FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080708 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   to compare the effect of panchwalkaladi mouth gel and mouthwash with kanchanara guggulu in the management of tonsillitis 
Scientific Title of Study   Comparative efficacy of Panchwalkaladi mouth gel and mouthwash along with Kanchanara guggulu (orally) in the management of Tundikeri-Tonsillitis An open label double arm randomised controlled trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Suchitra Maurya 
Designation  MS scholar  
Affiliation   
Address  505 seminar hall Department of Shalakya tantra All India Institute of Ayurveda Guatampuri Sarita vihar New Delhi south delhi 110076 india

South
DELHI
110076
India 
Phone  7011844711  
Fax    
Email  ssonumaurya100@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr manjusha rajagopala 
Designation  professor and head of department 
Affiliation   
Address  room number 512 All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 room number 512

South
DELHI
110076
India 
Phone  9560788850  
Fax    
Email  hod-shalakya@aiia.gov.in  
 
Details of Contact Person
Public Query
 
Name  Dr Manjusha Rajagopala 
Designation  Professor and Head of department 
Affiliation  Al 
Address  room number 512 All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076

South
DELHI
110076
India 
Phone  9560788850  
Fax    
Email  hod-shalakya@aiia.gov.in  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Guatampuri Sarita vihar New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  Gautampuri Sarita vihar New Delhi 110076 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Suchitra Maurya  OPD No.102,208,All India Institute Of Ayurveda  Room No-505 Department Of Shalakya tantra 5th floor Academic block All India Institute Of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 South DELHI
South
DELHI 
7011844711

ssonumaurya100@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIA INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J039||Acute tonsillitis, unspecified. Ayurveda Condition: TUNDIKERI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: kanchanara guggulu, Reference: sharangdhar samhita, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: koshana jal), Additional Information:
2Intervention ArmProcedure-pratisAraNam, प्रतिसारणम् (Procedure Reference: Susruta samhita, Procedure details: Pratisarana with panchawalkaldi gel 2 times a day)
(1) Medicine Name: Panchawalkaladi gel, Reference: Bhavaprakasa, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0.5(mg), Frequency: bd, Duration: 6 Weeks
3Comparator ArmProcedure-gaNDUShaH, गण्डूषः (Procedure Reference: Ashtangahridayam, Procedure details: Gandusha will be done with Panchawalkala mouth wash twice a day)
(1) Medicine Name: Panchawalkala mouthwash, Reference: Bhavaprakasha, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: bd, Duration: 6 Weeks
4Comparator ArmDrugClassical(1) Medicine Name: Kanchanara guggulu, Reference: Sharangadhara samhita, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients having sign and symptoms of Tundikeri
Patients aged between 12-40 years of age irrespective of sex.
Patients who are willing to participate in the study and give consent
 
 
ExclusionCriteria 
Details  Patients with complications of Tonsillitis like Peritonsillar Abscess Parapharyngeal Abscess
Malignancy syphilis and TB presenting as tonsillar disease
Immunocompromised patients like cancer syphilis etc
Patients who are on other medication which may alter the result of study
To avoid further complication through disease
Pregnant and lactating female
Cases which require surgical intervention
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in signs and symptoms of Tundikeri Tonsillitis ie Congestion and Dysphagia  Before treatment and After treatment (42th day) 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in signs & symptoms of Tundikeri Tonsillitis ie Fever Pain size of tonsils burning sensation halitosis follicles on tonsils lymph node enlargement
To assess the antimicrobial & anti inflammatory activity on causative micro organisms
To evaluate the changes in hematological parameters in registered patient
 
Before treatment & After treatment (42th day) 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   25/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 

 

RESEARCH QUESTION

What is the efficacy of Panchwalakaladi mouth gel along with Kanchanara Guggulu in comparison to the Panchwalakaladi mouthwash along with Kanchanara Guggulu for the duration of 6weeks in the management of Tundikeri – Tonsillitis?

 

HYPOTHESIS

The oral administration of Panchwalakaladi mouth gel along with Kanchanara Guggulu is more effective than Panchwalakaladi mouthwash along with Kanchanara Guggulu for the duration of 6 weeks in the management of Tundikeri (Tonsillitis).

 

 

NULL HYPOTHESIS(H0)

The oral administration of Panchwalakaladi mouth gel along with Kanchanara Guggulu is not more effective than Panchwalakaladi mouthwash along with Kanchanara Guggulu for the duration of 6weeks in the management of Tundikeri (Tonsillitis).

 

 

ALTERNATE HYPOTHESIS(H1)

The oral administration of Panchwalakaladi mouth gel along with Kanchanara Guggulu is more effective than Panchwalakaladi mouthwash along with Kanchanara Guggulu for the duration of 6 weeks in the management of Tundikeri (Tonsillitis).

 

 

 

 

INTRODUCTION

Tonsillitis is a common illness in the childhood period resulting from pharyngitis.A person of any sex   and age may fall victim to bacterial infection, leading to tonsillitis is a common condition with nearly all children being infected at least once.  It is rare in infants and in persons who are above 50 years of age.1

It may be viral or bacterial. Clinical features are sore throat, dysphagia, earache, hyperemia of pillars, soft palate, and uvula, enlarged and tender cervical lymph nodes, pyrexia, etc. The treatment may include plenty of fluids, analgesics, and antimicrobial therapy. If not managed properly and on time, may lead to chronic tonsillitis, peritonsillar abscess, cervical abscess, acute otitis media, etc.

Chronic tonsillitis may be a complication of acute tonsillitis. Mostly it affects children and young adults and rarely occurs after 50 years. Chronic infection in sinuses or teeth may be a predisposing factor2. The Clinical features include recurrent attacks of sore throat with the cough, halitosis, dysphagia, and choking spells at night. Conservative treatment consists of orientation to general health with treatment of co-existent factors of teeth, nose, and sinuses. Tonsillectomy is indicated when tonsils interfere with speech, deglutination, and respiration3.

 

The clinical features of Tundikeri (NAMC CODE- GE-3) explained in the classics are similar to Tonsillitis.. Acharya Shushruta considered Tundikeri as Talugata Roga and Acharya Vagbhatt mentioned it in Kanthagata Roga under the heading of Mukha Roga. Tundikeri is due to vitiation of Kapha-Rakta

,there is manifestation of Shopha near Talu or Hanusandhi which resemble like Karpasa Phala and having characteristics like Shotha,Toda, Daha,Prapaka, Pichhila, Mandaruja etc .

 

 

 

NEED OF STUDY

There are about 7,455,494 cases of tonsillitis in India per year.14

Tonsillitis is a highly prevalent disease and is recurrent. Around 200,000 tonsillectomies are performed in India per year and they have complications associated with them.

Though the disease is managed by antibiotic regimen, The frequent episode of infection are justifiable for tonsillectomy. However surgical management is also having its own merits and demerits with limitations. Considering all these points there is a need to search and effective and safe treatment. This study is to highlight the efficacy of ayurvedic medicines in relieving the clinical features of Tundikeri.

Tundikeri (Tonsillitis) under the Talugata roga is one the most common disease with prevalence rate of 56% in 11-21 years of age group, 20% in 21-30 years of age group and 9% in 31-40 years of age group4. The recurrent attack of tonsillitis makes the disease chronic & vulnerable for other infectious diseases.

·       Few works have been carried out on tonsillitis at various institutions, among them one of the study has been conducted on tundikeri by Dr Kanika Bhatia et al entitiled “ The EFFICACY OF KANCHANARA GUGGULU WITH AND WITHOUT PANCHAVALKALADI GANDUSHA IN TUNDIKERI (TONSILLITIS) IN CHILDREN – AN OPEN LABELLED RANDOMIZED CONTROLLED CLINICAL TRIAL” and the study shows encouraging results. Based on this study further work shall be conducted. The present work aims to explore a novel topical formulation in the form of gel, as alternative formulations have certain drawbacks.to assess the effect of local application of Panchwalakaladi mouth gel/ mouth paint along with the Kanchanara Gugggulu, in the patients of tundikeri.

 

 

 

 

Benefits of Panchwalakaladi mouth gel/ mouth paint

·      Easy to apply

·      Not required to prepare freshly on daily basis.

·      Remains on lesion for longer duration.

·      Can be applied directly to the lesion.

·      Product is not wasted on unaffected area during application.

·      Application process require comparatively less time.

·      The product can be stored easily.

·      Comparatively less chances of spillage of the product.

·      Asepsis can be maintained easily.

 

REVIEW OF LITERATURE-

CLASSICAL-

a) Acharya Sushruta has described Mukharogas in Nidanasthana. There are 65 types of Mukharogas5 that occur in Saptaayatana i.e., seven regions which are: Aushtha, Dantamoola, Danta, Jihwa, Talu, Kantha and Sarva Mukha. Out of them, 8 occur in Aushtha, 15 in Dantamoola, 8 in Danta, 5 in Jihwa, 9 in Talu, 17 in Kantha and 3 in Sarva Mukha.  9 Talugata Roga namely Galshundika,Tundikeri, Adhrush, Manskachapa, Arbuda, Mansa-Sanghaat, Talupupputa, Talushosha, Talupaka.

Tundikeri is   defined as “Tundikerikarpasyamvanakarpasi phalm”which means Tundikeri resembles VanakarpasikaPhalam(cotton fruit)6. It is a disease which is caused by the vitiation of kapha and Rakta.

b) In Charaka Samhita, there is no direct reference about Tundikeri. But it can be taken under the context of  Ekadesheeya Shotha (localized swelling)7

c)Acharya Vagbhata considered it under the heading of Kathagataroga . Tundikeri exhibits Katina- shopha (hard swelling), resembling the fruits of karpasa situated at hanusandhi associated with pichchilata and mandaruka8

d)Yogaratnakara considered Tundikeri as a much painful disease.

Treatment principle

1.Shamana chikitsa: shoolahara, shotha hara, grandhi hara along with the , Gandusha, Kavala, dhooma, nasya.

2. Shastra chikitsa:  for Tundikeri is the same that of Galashundika, but only the difference is Bhedana karma is mentioned in place of Chedana according to Acharya Sushruta. The other treatment modalities in Ayurveda include the raktaavsechan, Pratisarana and Kshara karma.

Shastrakarma elaborated for Galashundika (Chedana) can be adopted in later stage.

 

CONTEMPORARY-

Tonsillitis is the inflammation of the tonsils, typically of rapid onset of Acute tonsillitis symptoms may include sore, throat, fever, enlargement of tonsils, large lymph nodes around the neck. It is commonly encountered nowadays due to the dietary habit of taking spicy food, cold beverages and cold climate.

 

Acute infection16 of the tonsil may involve these components and are thus classified as:

 

1.       Acute catarrhal or superficial tonsillitis

 

2.       Acute follicular tonsillitis

 

3.       Acute parenchymatous tonsillitis

 

4.       Acute membranous tonsillitis

 

 

Haemolytic streptococcus is the most commonly infecting organism. Other causes of infection may be    staphylococci, pneumococci or H. influenza. The treatment for acute tonsillitis will be bed rest, plenty of fluids, and administration of analgesics and antibiotics. If not managed properly and on time, it may lead to complications like peritonsillar abscess, parapharyngeal abscess, acute otitis media, rheumatic fever or may turn into chronic tonsillitis.

 

Chronic tonsillitis15

TYPES

1. CHRONIC FOLLICULAR TONSILLITIS. Tonsil crypts are full of infected cheesy material which shows on the surface as yellowish spots.

2. CHRONIC PARENCHYMATOUS TONSILLITIS. There is hyperplasia of lymphoid tissue. Tonsils are very much enlarged and may interfere with speech, deglutition and respiration (Figure 51.6). Attacks of sleep apnea may occur. Long-standing cases develop features of cor pulmonale.

3. CHRONIC FIBROID TONSILLITIS. Tonsils are small but infected, with history of repeated sore throats

TREATMENT

1.    Conservative treatment consists of attention oral health, diet, treatment of coexistent infection, nose and sinuses

2.    Tonsillectomy is indicated when tonsils in speech, deglutition and respiration or cause of recurrent attacks.

COMPLICATIONS

1.    Peritonsillar abscess.

2.    Intratonsillar abscess.

3.    Tonsilloliths.

4.    Tonsillar cyst

5.    Focus of infection in theumatic fever, acute nephritis, eye and skin disorders.

CLINICAL FEATURES

1.    Recurrent attacks of sore throat or acute tonsillitis

2.    Chronic irritation in throat with cough.

3.    Bad Taste in mouth and foul breath (halitosis) due to in swallowing and pas in crypts.

PREVIOUS RESEARCH WORK DONE

       

Name

Research topic

Group

Intervention

Result

Singh Baldev (PG)

1990

– A clinical study on Tundikeri (with special reference to Tonsillitis)

the study was divided into 3 groups in which group 1- tundikerihar vati1.5 gm daily in three divided doses,

group 2- marichyadi churan with honey for pratisaran tds, and group 3- combined therapy of both groups.

Marichyadi churan with honey for pratisaran

Group 3 showed better results in cardinal and associated sign and symptoms.

 

Pandey Uma (PG)– 1994

Role of Kalka Churna in the management of Tundikeri (Tonsillitis)

group1-wheat powder capsule of 1 gm tds, group2- kalak churan 1 gm with honey orally

group3-kalak churan 1 gm with honey for pratisaran,

group4-combined therapy of group 2 and 3.

 

kalak churan

honey orally

 

Group4 showed better results in cardinal and associated and associated symptoms and hematological value. Statistically high

Ram Babu Paswan (Ph.D.)  -2007

A Pharmacognostic, Phytochemical, and pharmacological studies on Hastishundi (heliotropium indicum Linn.) and allied species Heliotropium ovalifolium forsk. and their effect on Tundikeri (Tonsillitis)

 

Heliotropium ovalifolium forsk

group B – H. ovalifolium showed better results than group A)

 

 

Adhvaryu Tarak R. –2014

 

A clinical study on Tundikeri (Tonsillitis) in children & its management with Kanchanara Guggulu and Tankan-Madhu Pratisarana–

total of 31 patients aged between 5 and 16 years. Kanchnara Guggulu tablets were administered orally in Group A and in Group B, Pratisarana with Tankana- Madhu was done along with the oral administration of Kanchnara Guggulu tablets.

Kanchnara Guggulu tablets And Pratisarana with Tankana- Madhu

The results showed that in Group A, 21.43% of patients got complete remission, 42.86% of patients got marked improvement and 35.71% of patients got moderate improvement. In Group B, 25% of patients got complete remission, 58.33% of patients got marked improvement and 16.67% of patients got moderate improvement.

 

 

 

 

 

 

Other Work Done

HASSAN-

Amit Deshmukh –Clinical management of Tundikeri by Sphatika in children - (2000-2001)

Samudri Mohd. Asraf D –A clinical trial on Kshara Karma as a para-surgical procedure in Tundikeri (Tonsillitis)- (2002-2003)

PAPROLA-

Rajni Sawhney- Role of Ayurvedic drugs in the management of Tundikeri w.s.r. to Tonsillitis -2004

 

 

 

JAIPUR-

Sudhakar Sharma –Balakon ke Tundikeri ke Pariprekshya mein Peetaka Yoga ka Prabhavatmaka Adhyayan–1993

V K Panda–The effect of Kanchanara Twaka in the management of Tundikeri(Tonsillitis) of the children – 1997

PUNE-

Potdar Piyush P- Study the efficacy of Gandhaka Rasayana in Acute Tonsillitis – 2005

 

KERALA-

Jayan B.- Management of Tundikeri (Tonsillitis ) w.s.r. to Tankana - Madhu Pratisarana -1993

Preetha A – Effect of Sahadevadi Lepa in the Management of Tonsillitis – 1996

Anil Kumar M V – A study on the preventive aspects of recurrent Tonsillitis in children – 1998

Beena K – A clinical study on the effect of Sasaruthi (Emila sanctifolia ) in Tonsillitis –2000

BENGALURU-

Kousalya N.-Efficacy of Vachadi Kavalgraha & Triphaladya Guggul on Tundikeri – A clistudy -2

 

OBJECTIVE OF RESEARCH

 

PRIMARY OBJECTIVE

To evaluate the efficacy of Panchwalakaladi mouth gel along with Kanchanara guggulu in comparison to Panchwalakaladi Mouthwash with Kanchanara guggulu in the reduction of severity of cardinal features of Tundikeri i.e. Congestion and Dysphagia.

 

 

SECONDARY OBJECTIVE-

 

1.To evaluate the efficacy of Panchwalakaladi mouth gel along and Kanchanara guggulu in the reduction of severity of cardinal features of Tundikeri i.e. Congestion and Dysphagia.

2.To assess the antimicrobial activity of Kanchanara Guggulu and Panchwalakaladi mouth gel on common strains of Tonsillitis.

3.To evaluate the changes in hematological parameters in registered participants

 

METHODOLOGY

STUDY TYPE

Randomized Interventional Clinical study

PURPOSE

Treatment

MASKING

Open labelled

CONTROL

Controlled

TIMING

Prospective

END POINT

Efficacy

SAMPLE SIZE

64 (32 each group)

GROUPS

Patients are randomly allocated in two groups

Problem study

Hypertrophy of tonsil (CA0F.0)

Tundikeri NAMC CODE-GE-3, GF-2

Acute tonsillitis unspecified (CA03.Z) excluding streptococcus haemolyticus

Chronic disease of tonsils or adenoids unspecified (CA0F.Z)

Age group

12-40 year.

 

Study aims to see the differential response on cardinal features of tundikeri

 In patients of 12-40 years.

 

SAMPLE SIZE CALCULATION-

The study is planned to evaluate the improvement in cardinal signs of dysphagia and congestion (throat) in the patient of Tundikeri and to compare the effect of Panchwalakaladi mouth gel and Panchwalakaladi mouth wash with Kanchanara Gugggulu in both groups.

It is assumed that Panchwalakaladi gel would give 70% improvement symptomatically than 50% in mouthwash group.

Assuming the allocation ratio 1:1

80% power

5% level of significance and the two-sided test.

 

Assumption:

The observation is independent.

The variable under study is continuous or ordinal.

Formula:

n=    (Zα/2+ zβ) 2

12c (1 – c) (pn-0.5)2

pn =probability that a score from X is larger than a score from

Y is larger than ½.

c =1/1+k where k=allocation ratio.

The calculated sample size is 32 per group assuming 10% drop out it will be 35 per group.

 

STATISTICAL METHODS FOR ANALYSIS:

The base line data collected would be compared for frequency distribution using Chi square test, Mean Median, Standard deviation etc. would be calculated as necessary.

 

p (level of significance) <0.05

 

For objective parameters:

1. Paired t-test will be used to assess’ results for individual groups.

2. Unpaired t-test will be used to calculate the comparison of results between the groups.

 

For subjective parameters:

1. Wilcoxon signed-rank test will be used to assess’ results for individual group.

2. Mann-Whitney U test will be used to calculate the comparison of results between the groups.

 

Assumption:

The observation are independent.

The variable under study is continuous or ordinal.

 

 

Randomization: -

The patients divided into two groups on the basis of computerized random number chart.

 

METHOD OF PREPERATION

1.A detailed study of Tundikeri in Ayurvedic Classics and all the contemporary modern texts will be done.

2.The detailed review of the selected drug and authentication of procured drug will be done and the drug will be prepared in the pharmacy of AIIA if feasible or can be procured from GMP certified pharmaceutical company

3.Therapeutic intervention

 

 

 

SETTING:

Clinical study- for clinical study patient attending OPD of Shalakya tantra, All India institute of ayurveda Delhi, would be selected randomly based on the signs and symptoms of tundikeri (tonsillitis) irrespective of their sex, habitat, and religion etc. The eligible population will be divided into two groups.

 

 

CRITERIA FOR SELECTION–

 

Inclusion criteria-

1.    Patients having sign and symptoms of Tundikeri.

2.    Patients aged between 12-40 years of age, irrespective of sex.

3.    Patients who are willing to participate in the study and give consent.

 

Exclusion Criteria –

1.Patients with complications of Tonsillitis like Peritonsillar Abscess, Parapharyngeal Abscess.

2.Malignancy, syphilis, and T.B. presenting as tonsillar disease,

3. Immuno-compromised patients like cancer, syphilis etc.

4. Patients who are on other medication which may alter the result of study.

5. To avoid further complication through disease.

6.Pregnant and lactating female.

7.Cases which require surgical intervention

 

CRITERIA FOR DIAGNOSIS: -

1. History

2. Physical examination

3. On the basis of subjective and objective criteria of disease Tundikeri.

Subjective Parameters: -

Shotha (inflammation)

Prapaka (Suppuration)

Mukhadaurgandhya (halitosis)

Toda (pricking pain)

Daha (Burning sensation)

Galoparodha (dysphagia)

 

Objective Parameters: -

Raga (Reddish discoloration)

Lymph node enlargement

Follicles on tonsils

Size of tonsils

 

INVESTIGATIONS

1. Routine hematological (HB,TLC,DLC,ESR) will be carried out.

2. Swab culture of patients will be taken before and after treatment to access antimicrobial and anti-inflammatory activity.

3. The AIIA hospital’s laboratory will be the site of the aforementioned testing.

Sample collection: 5ml of venous blood will be taken from the arm using sterile techniques. Needle and syringe following a single puncture.

4. In accordance with the instructions, the patient will be instructed to tilt their head back and open their mouth wide for the throat swab. Only on those patients who haven’t taken any kind of antibiotic in last 1 month.Wearing gloves, the healthcare professional will move the sterile cotton swab up and down the tonsils in the throat.

 

GROUPING :

- Patients are randomly allocated using computerized randomization into two groups.

Groups are coded as A and B.

GROUP A :- Panchwalakaladi mouth gel along with Kanchanara Guggulu.

GROUP B:- Panchwalakaladi Gandusha/Mouthwash along with Kanchanara Guggulu

Groups

Drug

Duration

Anupana

Aushadhkaal

GROUP A

Kanchanara

Guggulu

 

 

 

Panchwakaladi mouth gel

 

6weeks

 

 

6weeks

Koshna jala

After food

(two times a day)

 

 

Gel is applied according to size of lesion two times a day(quantity sufficient for oral mucosa)

GROUP B

Kanchanara

Guggulu

 

 

Panchwakaladi

Gandusha

/Mouthwash

6weeks

 

 

6weeks

Koshna jala

After food

(two times a day)

 

10-15ml with luke warm water, according to the requirement (QS)-morning and evening for 3-5 minutes.

 

 

 

 

 

 

 

 

 

 

 

 

1.Kanchnara Gugggulu is mentioned in Sharanghar Samhita.

Ingredients of Kanchanara Gugggulu

 

Sno.

Drug

Botanical name

Rasa

Guna

Veerya

Vipaka

1

Kanchnaar Twak

Bauhinia variegeta Linn.

Kashaya

Laghu ruksha

Sheeta

Madhura

2

Haritki

Terminalia chebula Retz.

Madhura amala katu tikta kashaya

Laghu ruksha

Ushna

Madhura

3

Bibhitaki

Terminalia bellerica Roxb.

kashaya

Laghu ruksha

Ushna

Madhura

4

Amalaki

Emblica officinalis Gaertn.

Madhura amala katu tikta kashaya

Laghu ruksha

Sheeta

Madhura

5

Shunthi

Zingiber officinale Roxb.

Katu

Laghu snigdha

Ushna

Katu

6

Maricha

Piper nigrum Linn.

Katu tikta

Laghu ruksha tikshana

Ushna

Madhura

7

Pippali

Piper longum Linn.

Madhura katu tikta

Laghu snigdha

Anushna

Katu

8

Varuna

Cretaeva nurvala Buch-Ham

Tikta kashaya

Laghu ruksha

Ushna

Katu

9

Twak

Cinnamomum zeylanicum Breyn

Madhura katu tikta

Laghu ruksha tikshana

Ushna

Katu

10

Tamla patra

Cinnamomum tamala Nees and Eberm

Madhura katu

Laghu pichchhila tikshana

Sheeta

Madhura

11

Ela

Elettaria cardamomum Maton

Madhura katu

laghu

Ushna

Katu

12

Guggulu

Commophora mukul Engl..

Katu tikta kashaya

Laghu sara vishada

 

 

 

 

 

2.Panchwakal kwath Gandusha:

Ingredients of Panchwakaladi kwath

Panchavalakala Kwatha (Vatadi Varga and Mukhroga Chikitsa),

Bhavaprakasha of Bhavamishra.

Sno.

Drug

Botanical name

Rasa

Guna

Veerya

Vipaka

1

Vata

Ficus benghalensis Linn.

Kashaya

Guru Rooksha

Sheeta

Katu

2

Udumbara

Ficus racemosa Linn.

Kashaya

Guru Rooksha

Sheeta

Katu

3

Ashwatha

Ficus religiosa Linn.

Kashaya

Madhura

Guru Rooksha

Sheeta

Katu

4

Parish/ shirisha

Thespesia populnea (Linn.) Sol.ex Correa./ Albizia lebbeck (Linn.) Benth

Kashaya

Guru Rooksha

Sheeta

Katu

5

Plaksha

Ficus lacor Buch. Ham.

Kashaya

Guru Rooksha

Sheeta

Katu

 

 

 

DOSE AND DOSAGE FORM:

Psology

The adult dose Kanchanara Guggulu is 3gm13

Dose for the age group 12-20 years was calculated by applying Dilling’s formula

Adult dose X (age in years /20)

 

Age in years

Kanchanara Guggulu dose

Route

Anupana

Duration

12-20

500mg (1tab thrice a day)

 

oral

Koshana jal

6weeks

21-40

500mg (2 tab thrice a day)

oral

Koshana jal

6weeks

 

 

Age in years

Kanchanara

Guggulu dose

Route

Anupana

Duration

12-20

500mg (1tab thrice a day)

 

oral

Koshana jal

6weeks

21-40

500mg (2 tab thrice a day)

oral

Koshana jal

6weeks

 

 

Gandusha dosage:

For a period of six weeks, take 10-15millilitres with lukewarm water according to the requirement (QS) twice a day for three to five minutes in the morning and evening. Administration method and route: Gandusha administered orally.

The drugs will either be manufactured at AIIA or obtained from a pharmacy with a GMP certification

PROCEDURE FOR GANDUSHA

Formulation of Panchwalakaladi mouthwash in the form of liquid will be given to patient for Gandusha two times a day – morning and evening and patient will be asked to hold the Kwath in mouth to its full capacity for about 3-5 minutes. As Panchwalakaladi Gandusha will be provided to the patient in concentrated form, patient will be advised to add warm water into the Gandusha according to the requirement. Patient will be advised to tilt his head slightly upwards and hold liquid in mouth till the Kapola becomes full of Kapha secretion starts in Nasa and Netra12. The patient will be advised to spit out the beverage if any of these symptoms occur initially.

 

Total Duration: 9 weeks

Trial Duration- 6 weeks

Follow up: 3 weeks

ASSESMENT TIME: Before treatment and After treatment (42th day).

 

WITHDRAWL CRITERIA:

1)Patients have a negative reaction to the drug.

2)Children or guardians unwilling to continue the treatment.

The patient will be removed from the study with appropriate data recorders to be examined at the conclusion.

 

 

RESCUE MEDICATION

To alleviate any emergency, the use of rescue medication will be done as per the need of the patient, disease condition and discretion of the Investigator.

 

MANAGEMENT OF ADVERSE CASES

1.In the event that therapy has any unfavorable effects, more pharmaceutical medications may be recommended after consulting with modern physicians, or alternative ayurvedic medications may be given after consulting with specialists in the relevant domains.

2. The Pharmacovigilance Department or Cell of the AIIA must be notified of any adverse occurrence or response. The patient will return to the study once they are stabilized, under the guidance of the project’s mentors.

3. Information about these occurrences, including the length of the absence, kind, and dosages of the extra medications, will be noticed, documented, examined, and shared.

 

PARAMETER FOR ASSESSMENT OF STUDY OUTCOMES

•         Complete remission: R = 100% relief in the complaints.

•         Marked improvement: 76% ≤ R < 99% relief in the complaints.

•         Moderate improvement: 51%≤ R < 75%relief in the complaints.

•         Mild Improvement: 26%≤ R < 50%relief in the complaints.

•         Unchanged: Less than 0 ≤ R <25% relief in the complaint

 

 

PRIMARY OUTCOME-

Changes in signs and symptoms of Tundikeri -Tonsillitis i.e. Congestion and Dysphagia.

 

SECONDARY OUTCOME-

1.Changes in signs and symptoms of Tundikeri -Tonsillitis i.e. Fever, Pain, size of tonsils, burning sensation, halitosis, follicles on tonsils, lymph node enlargement.

2.To assess the antimicrobial and anti-inflammatory activity on causative micro-organisms.

3.To evaluate the changes in hematological parameters in registered patient.

 

Ethics committee clearance: -

1.Only after receiving approval from IEC AIIA Sarita Vihar, New Delhi, would the study begin.

2. Prior to the child’s enrollment in the study, the parent or guardian’s written informed agreement or assent will be obtained.

3. Any ADR that is reported by parents or kids will be noted and reported.

 

CO-OPERATION REQUIRED:-

Doing the research with assistance from the following AIIA, New Delhi departments.

1)       Department of Dravyaguna

2)       Department of Rog Nidana and Vikriti Vigyana.

3)       Department of Ras Shastra and Bhaishajya Kalpana.

4)       Department of Shalakya Tantra

 

 

PATIENT COMPLIANCE PROTOCOL

The relevance of the treatment plan, any possible side effects, and the anticipated results will all be clearly communicated to the participants.

The treatment plan will be covered in written instructions, which can be downloaded or printed. Doses, timing, and any other pertinent information might be included in this. To remind patients to take their medications or adhere to their treatment plans a compliance chart will be given to the patient along with recall through text messages

 

TRANSLATIONAL VALUE

Tonsillitis is a highly prevalent disease and is recurrent. There are about 7,455,494 cases of tonsillitis in India per year1. and they have complications associated with them. Though the disease is managed by antibiotic regimen causing antibiotic resistance. Surgical intervention also have adverse affect and removing lymphoid tissue increase susceptibility to further infection in long term. Considering all these points there is a need to search and effective and safe treatment.

 

CONTINUTIY OF CARE

After the study period is over, If the patient needs treatment for tonsillitis or any other symptom, appropriate advice and management will be provided in accordance with AIIA hospital policies.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GANTT CHART

ACTIVITIES

JAN 2024

FEB-APR

2024

APR-JUL

2024

AUG-OCT

2024

OCT 2024-FEB 2026

MAR

2026

APR 2026

MAY-JUNE

2026

SELECTION OF RESEARCH PROBLEM

REVIEW OF LITRATURE

PREPRATION OF SYNOPSIS

SUBMISSION OF SYNOPSIS

PRESENTATION OF SYNOPSIS

RE-EVALUATION OF SYNOPSIS AFTER IRB SUGGESTIONS

RE-SUBMISSION OF SYNOPSIS

PREPRATION OF PATIENT CONSENT FORM, PATIENT INFORMATION SHEET, CASE RECORD FORMS

IEC CLEARANCE

CTRI REGISTRATION

PROCUREMENT AND PREPRATION OF TRIAL DRUGS

RECRUITMENT OF SUBJECTS

COMMENCEMENT OF TRIAL

DATA ANALYSIS

SUBMISSION OF THESIS

 

 

 

 

 

DECLARATION BY CANDIDATE: -

 

I hereby declare that I would abide by the rules and regulations of the institution and university and this study will be completed with the time limit.

 

Name and sign of Scholar

Dr Suchitra Maurya

 

 

 

 

Name and sign of Guide:

Dr (Prof.) Manjusha Rajagopala

 

 

 

 

Name and sign of Co-guide: -

1.Dr Prashant Kumar Gupta

 

 

 

 

 

 

 

 

 

 

ESTIMATED BUDGET

DRUG

PRICE IN RUPESS

KANCHANARA GUGGULU

16000

PANCHWALKALADI GEL

20000

PANCHWALKALADI MOUTHWASH

10000

HB, TLC, DLC, ESR

22000

CULTURE AND SENSITIVITY TEST

5700

TOTAL

73000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                                   ACTIVITY CHART

                                          Procurement of raw drug

                    

                                      Authentication of the drug

 


                                               Processing of the drug

 


                                           Packing of the drug

 


          Screening of the patients via inclusion and exclusion criteria

 


                       Enrolment of the patients in the study

 


             Base line evaluation before treatment with investigations

 


                      

 

                              Randomization of enrolled patients

 

 

 


Kanchanara Gugggulu with Panchwalakaladi Mouth gel      

GROUP A(n=32)                               GROUP B(n=32)                                                                                                                                                                                                                                 

Kanchanara Gugggulu with Panchwalakaladi Mouth wash

 

 

 

 

                                      Follow up of evaluated patient

 


                                Analysis and interpretation of data

 


                                    Report preparation and submission

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STANDARD PROTOCOL FOR TESTING

 

1.   Description

2.   Colour

3.   Odour

4.   Consistency/Uniformity of content

5.   Microscopic (if powdered drugs incorporated)

6.   Rancidity test

7.   Identifications, TLC/HPLC

8.   Assay (Wherever possible)

9.   Viscosity

10.                 PH

11.                 Particle size (if powdered drugs incorporated)

12.                 Mesh size 125- 150

13.                 Spread ability

14.                 Microbial contamination

Total bacterial count

Total fungal count

Test for specific Pathogen

15.                 E. coli

16.                 Salmonella spp.

17.                 S.aureus

18.                 Pseudomonas aeruginosa

19.                 Pesticide residue Organochlorine pesticides

20.                 Organophosphorus pesticides

 

 

 

 

 

 

 

Standardization  protocol for Vati

 

1.   Description

2.   Colour

3.   Odour

4.   Weight variation

5.   Disintegration time, not more than 60 minutes guggulu tablets

6.   Identification ILC/HPTLC/GLC

7.   Assay

8.   Microbial contamination

9.   Total bacterial count

10. Total fungal count

11. Test for specific Pathogen

12.  E. coli

13.  Salmonella spp.

14.  S.aureus

15. Pseudomonas aeruginosa

 

 


REFERANCES-

 

1.    Adhvaryu T, Patel K, Kori V, Rajagopala S, Manjusha R. Evaluation of the effect of Kanchnara Guggulu and Tankana-Madhu Pratisarana in the management of Tundikeri (tonsillitis) in children. AYU. 2016;37(3):190.

 

2.    Dhingra PL, Dhingra S. Diseases of Ear, Nose, And Throat. 8th ed. Delhi: Elsevier; 2021:chap 51, p. 307

 

3.    Dhingra PL, Dhingra S. Diseases of Ear, Nose, And Throat. 8th ed. Delhi: Elsevier; 2021:chap 51, p. 308

 

4.    MedPulse – International Medical Journal, ISSN: 2348-2516, EISSN: 2348-1897, Volume 2, Issue 11, November 2015

 

5.    Sushruta. Sushruta Samhita. In: Shastri A, ed. Nidanasthana, Chapter 16, Verse No. 3. Varanasi: Chaukhambha Sanskrit Sansthan; 2015. Reprint. p. 381

 

6.    Tripathi B, editor. Commentary: Nirmala Hindi Commentary on Ashtanga Hridya of Vagbhatta. In: UttaraSthana, Chapter 21, Verse No. 47. Delhi: Chaukhamba Sanskrit Pratishthan; 2014. Reprint. p. 1030.

 

7.    Shashtri K, Chaturvedi G, editors. Commentary: Vidyotini Hindi Commentary On Charaka Samhita Of Agnivesha. Volume I, Sutrasthana. Varanasi: Chaukhamba Bharti Academy; 2015. Reprint. p. 377.

 

8.    Brahamanand Tripathi editor, Commentary: Nirmala Hindi Commentary on Ashtanga Hridya of Vagbhatta, UttaraSthana, Chapter21, verse no. 47, Delhi: Chaukhamba Sanskrit Pratishthan; reprinted 2014; p.1030

 

9.    Dr. Indradev Tripathi ,dr. Daya Shankar Tripathi, commentary : Vaidyaprabha Hindi commentary on Yogratnakar, Mukharoga Nidana, verse no. 53, Varanasi , Chowkhamba Krishnadas Academy. P712.

 

10. Sharangadhara, Sharangadhara Samhita, Madhya Khand-2/2-6, Edited by Pt. Parashuram Shastri      Vidyasagar, 1st edi.Varanasi: Chaukhambha Surbharti Prakashana,2006.

 

11. Dr. Seemameena and Dr. Rashmi Gupta (2020)’Classical Uses of Haridra (Curcuma Longa)’, International Journal of Current Advanced Research,09(07),pp. 22712-22715. Available from: http://dx.doi.org/10.24327/ijcar.2020.22715.4488

 

12. Nitin A. Vyawahare, Mohan B. Yeole Ayurlog: National Journal of Research in Ayurved Science- 2020; (8) (2): 01- 0 Kaval Gandush in oral health: A Review on Kaval Gandush.

 

13. The Ayurvedic Formulary of India part-1, second revised English edition, section -5 guggulu, p-67.

 

14. Department of Medical Microbiology, Faculty of Medicine and Health Sciences, University Putra Malaysia, Selangor, Malaysia, Muthanna A, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, University Putra Malaysia, Selangor, Malaysia, Shamsuddin NH, Department of Family Medicine, Faculty of Medicine and Health Sciences, University Putra Malaysia, Selangor, Malaysia, Abdul Rashid A, et al. Diagnostic Accuracy of Centor Score for Diagnosis of Group A Streptococcal Pharyngitis among Adults in Primary Care Clinics in Malaysia. MJMS. 2022 Aug 29;29(4):88–97

 

15. Dhingra PL, Dhingra S. Diseases of Ear, Nose, And Throat. 7th ed. Delhi: Elsevier; 2018:chap 51, p. 294.

 

16. Dhingra PL, Dhingra S. Diseases of Ear, Nose, And Throat. 7th ed. Delhi: Elsevier; 2018:chap 51, p. 292.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Annexure- 1

GRADING PATTERN1:-

1)Toda (pain)

1

No pain

0

2

Mild intense pain

1

3

Pain during deglutition

2

4

Pain during rest

3

 

2)Daha (burning sensation)

 

1

No burning sensation

0

2

Occasional localised burning sensation

1

3

Localised mild burning sensation in a particular hour of day

2

4

Burning sensation throughout the day but tolerable

3

5

ntolerable (affecting daily routine activity) generalized burning sensation throughout the day.

4

 

 

3)Jwara (temperature)

 

1

Normal temperature

0

2

98.6-100 F

1

3

100-102 F

2

4

>102 F

3

 

 

 

4) Aruchi

 

1

Normal taste in food, feeling to eat food on time

0

2

Aruchi -feeling to take food but not having taste

1

3

Anannabhilasha – not feeling to take food even if hungry

2

4

Bhaktadvesh – aversion to food

3

5

Abhaktachchanda

4

 

5) Sore throat

 

1

No sore throat

0

2

Sore throat with pain but no difficulty in taking food

1

3

Sore throat with pain and difficulty in taking food

2

4

Sore throat with difficulty in taking liquid too

3

 

6) Halitos

 

1

No halitosis

0

2

Present only when opening of mouth completely

1

3

Present during talking

2

 

 

7) Hoarseness of voice

 

1

No hoarseness

0

2

Hoarseness after long and loud talk

1

3

Hoarseness throughout day but no difficulty in speech

2

4

Can not make speech

3

 

8) Dysphagia

 

1

No difficulty

0

2

Difficulty in taking solid food only

1

3

Difficulty in taking solid and liquid food

2

4

Difficulty in swallowing saliva

3

 

 

 

9) Prapaka

 

1

No prapaka

0

2

Mild prapaka

1

3

Moderate prapaka

2

4

Severe prapaka

3

 

10) Raga

 

1

No erythema

0

2

Faint

1

3

Light red

2

4

Moderate red

3

5

Bright red

4

 

11)Shoth (Inflammation)

 

1

No shotha

0

2

Tonsils cover 25% of oral cavity

1

3

Tonsils cover 50% of oral cavity

2

4

Tonsils cover 75% of oral cavity

3

5

Tonsils cover >75% of oral cavity

4

 

12) Enlargment of lymhphnode

 

1

Not palpable

0

2

Unilateral enlargement

1

3

B/L enlargement of lymphnode

2

4

Visible -prominent lymphnode

3

 

Annexure-2

Size of tonsils:

Grade

Descriptions

0

No tonsils seen

1

In tonsillar fossa

2

Visible beyond anterior pillars

3

Extended ¾ of way to midline

4

Completely obstructing airway; kissing tonsils

 

 

 

Brodsky Grading Scale2

•        Grade 0 - tonsils within the tonsillar fossa

•        Grade1 - tonsils just outside of tonsillar fossa and occupy

•        Grade 2 - tonsils occupy 26-50% of the oropharyngeal width

•        Grade 3 - tonsils occupy 51-75% of the oropharyngeal width

•        Grade 4 - tonsils occupy more than 75% of the oropharyngeal width.

 

Centor score for sore throat14:

•        Fever ≥ 38 °C

•        Absence of cough

•        Swollen anterior cervical lymph nodes

•        Tonsillar exudates or swelling

 

 

 
Close