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CTRI Number  CTRI/2020/03/024335 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 27/03/2020
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   Effect Of Kushtadi Powder Application In Tonsillitis 
Scientific Title of Study   Randomized Controlled Clinical Study On The Effect Of Kushtadi Choorna Pratisarana In Tundikeri W.S.R To Tonsillitis In Children. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayalekshmi S 
Designation  PG Scholar 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
Address  Sri Sri College Of Ayurvedic Science And Research 21st KM Kanakapura Road, PO-Udayapura
Department Of PG Studies In Kaumarabhritya 21st KM, Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA
560082
India 
Phone  7034902561  
Fax    
Email  mailjayalekshmis@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudheer B R 
Designation  HOD, Professor 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
Address  Department Of PG Studies In Kaumarabhritya SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 21ST KM KANAKAPURA ROAD, PO-UDAYAPURA
Department Of PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research
Bangalore Rural
KARNATAKA
560082
India 
Phone  9900175777  
Fax    
Email  sudheerbrao@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayalekshmi S 
Designation  PG Scholar 
Affiliation  SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH 
Address  Sri Sri college Of Ayurvedic Science And Research 21st KM, Kanakapura Road,PO-Udayapura
Department Of PG Studies In Kaumarabhritya Sri Sri College Of Ayurvedic Science And Research 21st KM, Kanakapura Road, PO-Udayapura
Bangalore Rural
KARNATAKA
560082
India 
Phone  7034902561  
Fax    
Email  mailjayalekshmis@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College Of Ayurvedic Science And Research 21st KM, Kanakapura Road, PO- Udayapura, Bengaluru, 560082  
 
Primary Sponsor  
Name  Sri Sri College Of Ayurvedic Science And Research 
Address  21st KM Kanakapura Road, PO-Udayapura, Bengaluru 
Type of Sponsor  Private 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 Sudheer B R  Sri Sri College Of Ayurvedic Science And Research  Department of PG Studies In Kaumarabhritya 21st KM, Kanakapura Road, PO- Udayapura
Bangalore Rural
KARNATAKA 
9900175777

sudheerbrao@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL 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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KUSHTADI CHURNA APPLICATION  2g. Of Kushtadi Choorna Will Be Applied Locally Over Tonsils In Children Diagnosed With Tonsillitis Once In A Day For 7 Days 
Comparator Agent  SPHATIKA BHASMA  2g. Of Sphatika Bhasma Will Be Applied Locally Over Tonsils In Children Diagnosed With Tonsillitis Once In A Day For 7 Days 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Subjects of age group of 6-10 years will be included.
2. Subjects of both gender will be included irrespective of Religion and Socioeconomic status.
3. Subjects diagnosed with Tundikeri(Tonsillitis) will be included.
4. Subjects in whom the consent form is signed by parents/Guardian will be included.
 
 
ExclusionCriteria 
Details  1. Subjects below 6 years and above 10 years will be excluded.
2. Subjects having other Chronic Systemic diseases like Post streptococcal Glomerulo nephritis, Rheumatic fever etc will be excluded.
3. Subjects with peritonsillar abscess, tonsillar cyst and tonsilolith will be excluded.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
By Application Of Kushtadi Choorna Over Tonsils Locally, Reduction In The Symptoms Of Tonsillitis Will Be Assessed by assessing Reduction In The Size Of Enlarged Tonsils, Throat pain, Odynophagia, Dysphagia, Congestion over Tonsils And Pillars, Cough, Fever, Jugulodygastric lymphedenopathy, Halitosis, Change in voice  7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To Compare The Effect Of Herbal And Mineral Medicines In Tonsillitis  7 Days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   31/03/2020 
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="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   UGC APPROVED JOURNALS 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Acute infections of the upper respiratory tract contribute to over 20% of the morbidity of the population with the highest incidence in children. Among upper respiratory infections, Tonsillitis most often occurs in children aged 5-15 years without gender difference. Sore throat has an annual incidence of 100 in 1000 with Tonsillitis accounting for approximately 32 in 1000 patients per year.

The Tonsils are the immune system’s first line of defense against pathogens whenever there is an infection in oral cavity and upper respiratory system which may make the tonsils vulnerable to infection and inflammation. Antibiotics are the main line of treatment for Tonsillitis in Allopathic system of medicine which treats the current infection, but repeated administration of antibiotics can lead to many adverse effects like Nausea, Abdominal pain and blotting, Loss of appetite etc.

The disease Tundikeri mentioned in Ayurveda can be correlated to Tonsillitis which is characterized by- swelling in the throat especially Hanusandhi similar to Karpasaphala(fruit of cotton plant) which is Pichila(slimy) Katina(hard) and having  Mandaruja(pain).

Tundikeri is one among the Mukhagataroga(Diseases of Oral cavity) as mentioned in different classics and Pratisarana(Local application)is considered as one among the main line of treatment in Tundikeri to reduce the local inflammation, pain and makes the deglutition easy.

In the current study Kushtadi choorna is selected for Pratisarana.

The drugs have Anti inflammatory, Anti microbial, Analgesic and Anti pyretic actions which may effectively control Tonsillitis at an initial stage and prevent secondary infections.

 
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