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CTRI Number  CTRI/2022/07/043987 [Registered on: 13/07/2022] Trial Registered Prospectively
Last Modified On: 01/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of the effect of Shigru Taila Nasya,Gaganesvara Rasa and Haritakyadi Churna Virechana in Allergic Rhinitis. 
Scientific Title of Study   A Randomized Clinical Trial on the Role of Shigru Taila Nasya and Gaganesvara Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference To Allergic Rhinitis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish Kumar Varshney 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda Deemed To Be University Jaipur  
Address  PG Department Of Shalakaya tantra National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Jaipur
Madhav Vilas Palace, Jorawar Singh Gate, Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9784596886  
Fax    
Email  varshney43manish@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Shamsa Fiaz 
Designation  Prof. and Head of Department Shalakya Tantra  
Affiliation  National Institute of Ayurveda Deemed To Be University Jaipur 
Address  PG Department Of Shalakaya tantra National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Jaipur
PG Department Of Shalakaya tantra, Room no 309, National Institute Of Ayurveda, Deemed To Be University, Madhav Vilas Palace, Jorawar Singh Gate, Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  8764009846  
Fax    
Email  shamsa_fiaz@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Manish Kumar Varshney 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda Deemed To Be University Jaipur 
Address  PG Department Of Shalakaya tantra National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Jaipur
Madhav Vilas Palace Jorawar Singh Gate Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9784596886  
Fax    
Email  varshney43manish@gmail.com  
 
Source of Monetary or Material Support  
National institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002  
 
Primary Sponsor  
Name  National institute Of Ayurveda Deemed To Be University Jaipur 
Address  Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002  
Type of Sponsor  Research institution and hospital 
 
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 
DrManish Kumar Varshney  National Institute Of Ayurveda Deemed To Be University Jaipur  Deparment Of Shalakya Tantra Madhav Vilas Palace Jorawar SIngh Gate Jaipur
Jaipur
RAJASTHAN 
9784596886

varshney43manish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIA IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J309||Allergic rhinitis, unspecified. Ayurveda Condition: VATAJAPRATISYAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Gaganesvara rasa, Reference: Sahasrayogam Rasa yoga prakarana 22/7, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: honey), Additional Information: Starting along with Nasya Karma
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: AshtangHridaya sutra sthana20/9-10, Procedure details: Patients will be advised Nasya on empty stomach by performing Abhyanga on neck, face, forehead followed by hot water fomentation. In Pradhana Karma, Nasya drug in the dose of 6 drops per nostril will be administered followed by Paschat Karma with Haridra stick Dhoomapana and Saindhava Jala Kavala following all SOP’s related to Nasya Karma. )
(1) Medicine Name: Shigru Taila , Reference: Vangasen samhita Nasarogadhikar-102, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 14 Days
3Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Susruta samhita utter tantra 24/20, Procedure details: Sarvanga Abhyanga with Dashamoola taila and Bhaspa sweda will be done for only one day. 2nd day in morning 6 to 10 gms of Haritakyadi Churna Virechana (depending upon type of kostha) will be administered with luke warm water on empty stomach. Samsarjana Karma -3 to7 days- based on Koshta Shuddhi. )
(1) Medicine Name: Haritakyadi churna , Reference: Charak Samhita chikitsa sthanam rasayana-1/25-28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  (1) Patients willing to participate in the study
(2) Patients between the age group of 18– 60 yrs.
(3) Patients presenting with signs and symptoms of Vataja Pratishyaya mentioned in Ayurvedic Classics and Allergic Rhinitis according to Allopathic science.

 
 
ExclusionCriteria 
Details  1.Patients having history of systemic disease as Diabetes Mellitus, Hypertension, Hypothyroidism.
2.Patients suffering from gross deviation of nasal septum, nasal tumours, adenoid hyperplasia, nasal polyps etc.
3.Pregnant women.
4.Patients not fit for Nasya therapy and Virechana.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in visual analogues scale.  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in nasal congestion and turbinate hypertrophy.  30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
08/12/2022 
Date of Study Completion (India) 17/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The increasing prevalence of Allergic Rhinitis has affected global health problem effecting a quarter of the world population. Over 400 million people suffer from Allergic Rhinitis around the world and to a large extent it remains under diagnosed and under treated. About 20-30% of  Indian population  suffer from  at least  one  allergic  disease where allergic rhinitis alone constitutes about 55% of all allergies.

Allergic Rhinitis symptoms result in sleep disturbances, fatigue, depressed mood and cognitive functions which impairs quality of life and productivity. Many treatment modalities are explained in Allopathic science like corticosteroids, anti allergic drugs, inhalers, antihistamines etc. but none of them are totally effective in curing the disease as well as preventing its recurrence, more over they have their own side effects. Although innumerable preparations are available in modern science, no drug ensures complete relief without any side effects and the chances of recurrences are relatively high. Hence there is a need for more effective, safe, treatment modality which is especially beneficial in chronic cases to treat this problem from grass root level.

             Kostha suddhi is very beneficial for removing the Doshas from the body especially in chronic cases as the Doshas are lodged in different parts of body. Sarvanga Abhyanga and Swedana help in diverting the Doshas from Shakhas to  Koshta which can then can be expelled through Haritakyadi Churna Virechana. Moreover, in Vataja Pratishyaya, as there is Vimarga gamana of Vata Dosha, Virechana does Shareera shodhana and Vata Anulomana and hence it can be beneficial in this disease.  Along with that, Nasya Karma is considered as the main Shodhana therapy to expel Doshas from the Shiras.  Hence Shigru Taila Nasya has been selected which is considered as a drug of choice in Vataja Pratishyaya. In order to promote Shamana effect, Gaganesvara rasa is selected for internal administration in patients suffering from Vataja Pratishyaya (Allergic Rhinitis). Hence this study entitled,A Randomized clinical Trial on the Role of Shigru Taila Nasya and Gaganesvara  Rasa with or without Haritakyadi  churna  Virechana in Vataja Pratishyaya with special reference To  Allergic Rhinitis is selected for providing a better relief without any recurrence in order to find an effective solution to the above problem for curing the disease from its root cause.

Aim and Objectives

Aim

To evaluate the efficacy of Shigru Taila Nasya, Gaganesvara Rasa with and without Haritakyadi Churna Virechana in  Vataja Pratishyaya with special reference to Allergic Rhinitis

Objectives

·         To evaluate the efficacy of Shigru Taila Nasya and Gaganesvara Rasa orally with Haritakyadi Churna Virechana  in Vataja Pratishyaya with special reference to Allergic Rhinitis.

·         To evaluate the efficacy of Shigru Taila Nasya and Gaganesvara Rasa orally without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference to Allergic Rhinitis

Study Medication:

Group A - 15 patients of Vataja Pratishyaya will be  given Haritakyadi Churna Virechana followed by Shigru Taila Nasya along with internal administration of Gaganesvara Rasa.  

Group B – 15 patients of Vataja Pratishyaya will be given Shigru Taila Nasya and   internal administration of Gaganesvara Rasa.

·   

·       Treatment Plan :

 

Treatment  

Duration

Follow up

Group- 1

Koshta Shuddi-

Sarvanga Abhyanga and Swedana for one day followed by 6 to 10 gms of Haritakyadi Churna  Virechana  given with luke warm water

Marsha Nasya with Shigru Taila in dosage of 6 drops each nostril

 

 

3 to 7 days as per Koshta shuddhi

 

 

14 days (2 sittings each of 7 days with an interval of 7 days in between).

 

 

 

 

 

 

 

Once in 15 days

2 follow ups after treatment

 

Gaganesvara Rasa 250 mg b.d. with honey

21 days Starting along with Nasya karma

 

Group- 2

 Marsha Nasya with Shigru Taila in dosage of 6 drops in each nostril.

14 days (2 sittings each of 7 days with an interval of 7 days in between).

 

Gaganesvara Rasa 250 mg b.d. with honey                                

21 days, starting along with Marsha Nasya.

 

 

 

·           Assessment Criteria: -

 To assess the relief  in signs and symptoms mentioned below, a specific scoring pattern  will be adopted.

a.      ShirohShoola /Shirogaurava (Headache)

b.      Tanusravapravartan (Rhinorrhoea)

c.       Kshavathu (Sneezing)

d.      Aanaddha Nasa (Nasal obstruction)

e.       Swaropaghata  (Hoarseness of voice)

f.       Kasa (Cough)

g.      Kandu (Itching)

h.      Nasal Congestion.

i.        Turbinate hypertrophy

 

●       Laboratory Investigations –

Following investigations will be carried out before and after trial.

1.      Absolute Eosinophil Count(AEC)

2.      CBC

3.      ESR

4.      Allergen- specific Ig E Antibody Test.

Hypothesis:-

  Null Hypothesis- H0

  There is no difference in the effect of Shigru Taila Nasya, Gaganesvara  Rasa with or without Haritakyadi Churna Virechana in Vataja Pratishyaya with special reference To Allergic Rhinitis.

Alternate Hypothesis-                                              

 There is difference in the effect of Shigru Taila Nasya, Gaganesvara  Rasa with or without Haritakyadi Churna Virechana  in  Vataja Pratishyaya with Special reference To Allergic Rhinitis.



 
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