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CTRI Number  CTRI/2017/01/007708 [Registered on: 16/01/2017] Trial Registered Retrospectively
Last Modified On: 10/01/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of Yavagrajadi Churna Pratisarana and Kaval with Triphala Guggulu in Tonsillitis 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY OF YAVAGRAJADI CHURNA PRATISARANA AND YAVAGRAJADI KAVAL WITH TRIPHALA GUGGULU IN THE MANAGEMENT OF TUNDIKERI (TONSILLITIS) 
Trial Acronym  TYPK 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ronakgiri Gosai 
Designation  MD Ayurved scholar 
Affiliation  Government Akhandanand Ayurvedic College Ahmedabad 
Address  Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad GUJARAT 380001
216 yashtownship ambaji road near shantiniketan school patan 384265
Patan
GUJARAT
380001
India 
Phone  9016689310  
Fax    
Email  dr.ronakgiri9889@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemangi B Shukla 
Designation  MD Ayurved Head of Department and Reader 
Affiliation  Government Akhandanand Ayurvedic College 
Address  Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad Gujarat 380001
Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad Gujarat 380001
Ahmadabad
GUJARAT
380001
India 
Phone  9825504280  
Fax    
Email  drhemangishukla@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemangi B Shukla 
Designation  MD Ayurved Head of Department and Reader 
Affiliation  Government Akhandanand Ayurvedic College 
Address  Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad Gujarat 380001
Head of Department and Reader Upgraded Department of Shalakyatantra Government Akhandanand Ayurvedic College Bhadra Ahmedabad Gujarat 380001
Ahmadabad
GUJARAT
380001
India 
Phone  9825504280  
Fax    
Email  drhemangishukla@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurvedic College Bhadra and Maniben Ayurved Hospital Asarva Ahmedabad Gujarat 380001 
 
Primary Sponsor  
Name  Government Akhandanand Ayurvedic college and Hospital Bhadra Ahmedabad Gujarat  
Address  room number 3 Opd Of Shalakyatantra department Government Akhandanand Ayurvedic College Bhadra and room number 23 post graduate section Maniben Ayurved Hospital Asarva Ahmedabad Gujarat 380001 
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 Ronakgiri Gosai  Room Number 3 OPD Of Shalakyatantra Department Govt Akhandanand Ayurved College and Hospital  Government Akhandanand Ayurvedic college and Hospital Bhadra Ahmedabad Gujarat 380001
Ahmadabad
GUJARAT 		 9016689310

dr.ronakgiri9889@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  TundikeriRoga(Tonsillitis),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  YAVAGRAJADI CHURNA PRATISARANA WITH TRIPHALA GUGGULU  Yavagrajadi churna will be taken in 1/2 Karshamatra (6 gm.).Then Madhu will be added in it as a Q.S and mixed well. Mixture will be applied over the tonsils with the help of sterile Karpaskrutosani salaka under the bright light source and keep up to Vaksat matra (approx. 2 min). Patient is advised not to swallow the medicine. Mukhasudhdhi will be carried out by gargling with lukewarm water after the Pratisarana. Duration- once in a day up to 7 days. Schedule- max. 3 schedules with the interval of 7 days. and triphala guggulu will be given orally, Dose-3 gm(500mg each tablet). Duration-three times per day upto 5 weeks Anupana-Lukewarm water 
Comparator Agent  YAVAGRAJADI KAVAL WITH TRIPHALA GUGGULU  Patient will be advised to lie down comfortably. Mridu Mukhabhynaga will be done with nirgundi taila followed with Mridu Sweda. The patient will be asked to withhold yavagrajadi kalka (6gm yavagrajadi churna , 12gm madhu) in the oral cavity and will be advised to move the liquid comfortably in the oral cavity in such a way that it should reach the oropharynx. The procedure will be continued till the Samyak Kavala Lakshana appears. Duration- once in a day up to 7 days. Schedule- max. 3 schedules with the interval of 7 days. and triphala guggulu will be given orally, Dose-3 gm(500mg each tablet). Duration-three times per day upto 5 weeks Anupana-Lukewarm water  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1 Catarrhal Tonsillitis
2 Follicular Tonsillitis
3 Parenchymatous tonsillitis
 
 
ExclusionCriteria 
Details  1 Membranous tonsillitis,
2 Patient with complication of tonsillitis like Peritonsillar Abscess and parapharyngeal Abscess etc
3 Malignancy syphilis or TB presenting as tonsillar disease diabetes Mellitus and Hypertension pregnancy
4 Presence of other somatic or mental disorder requiring treatment
5 Immune compromised patients
6 Patients not willing to be registered for the trial
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
improvement in swelling, pain, difficulty in swallowing  5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   06/08/2016 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a randomized, parallel  group trial  in department of Shalakyatantra opd at Government Akhandanand Ayurvedic College and Hospital

Ahmedabad,Gujarat. Acharya sushrut mentioned that Tundikeri (Tonsillitis) should be treated with the drugs having properties like lekhana, shothahar,sandhaniya, ropan, raktastambhana and vedanasthapana etc. The drug Yavagrajadi yoga and Triphala guggulu have all above properties.

Therefore in the present study Yavagrajadi churna Pratisarana (Local application) and Triphala guggulu (oral medicine)  have been selected for clinical trials in group P. Yavagrajadi kaval(Gargling)  and Triphala guggulu have been selected for clinical trials in group K.

Methods – 

In group P, yavagrajadi churna  will be applied locally (pratisarana) on tonsils for 2 minutes for maximum 3 weeks  and patient will be given orally Triphala guggulu for maximum 5 weeks.

In group K, patient will be asked to withhold sufficient quantity of yavagrajadi kalka  in the oral cavity and will be advised to move the liquid comfortably (kaval) for maximum 3 weeks and patient will be given orally Triphala guggulu for maximum 5 weeks.

In both groups triphala guggulu will be administered orally with lukewarm water. 

 
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