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CTRI Number  CTRI/2024/04/066070 [Registered on: 22/04/2024] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   role of ayurveda in the management of gout 
Scientific Title of Study   Efficacy of virechana followed by bodhi kashaya yoga basti and virechana followed by bodhi kashaya pana in the management of vatarakta w.s.r. to gout - An open labelled randomized comparative clinical 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  Rakesh Kumar Majhi 
Designation  MD Scholar 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  room no-423, department of panchakarma, 4th floor, Institute of Teaching and Research in Ayurveda, jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  7008056499  
Fax    
Email  rakeshkumarmajhi518@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha G Tank 
Designation  Reader 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  room no-423, department of panchakarma, 4th floor,Institute of Teaching and Research in Ayurveda, jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9825391284  
Fax    
Email  neha@itra.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Neha G Tank 
Designation  Reader 
Affiliation  Institute of Teaching and Research in Ayurveda, Jamnagar 
Address  room no-423, department of panchakarma, 4th floor, Institute of Teaching and Research in Ayurveda, jamnagar


GUJARAT
361008
India 
Phone  9825391284  
Fax    
Email  neha@itra.edu.in  
 
Source of Monetary or Material Support  
Institute of Teaching and Research in Ayurveda Jamnagar 
 
Primary Sponsor  
Name  Institute of Teaching and Research in Ayurveda Jamnagar 
Address  Opposite B-Division police station, Gurudwara road ,Jamnagar 361008 
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 
Dr Rakesh Kumar Majhi  Institute of Teaching and Research in Ayurveda  Room no-423, 4th floor, institute building, department of Panchakarma.
Jamnagar
GUJARAT 		 7008056499

rakeshkumarmajhi518@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Institute of Teaching and Research in Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charaka samhita chikitsha sathana 29, Procedure details: 1. Anuvasana basti- Madhuyashtiyadi taila- 120ml 2. Asthapan basti- Makshika(Honey)-60ml Saindhav(Rock salt)- 10gm Madhuyashtiyadi taila- 120ml Kalka(putoyavani) -30gm Kwatha- 400ml )
(1) Medicine Name: bodhi kasaya yoga basti, Reference: charaka samhita chikitsha sathana 29, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 600(ml), Frequency: od, Duration: 8 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka samhita sutra sthana 15,, Procedure details: Deepana & Pachana followed by Sneha pana followed by Virechana and Samsarjana karma.)
(1) Medicine Name: Aragwadha phala majja, Reference: Charaka samhita kalpa sthana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of either sex.
Diagnosed patients of gout.
Patients Yogya for Basti karma and Virechana.

 
 
ExclusionCriteria 
Details  Patient having uncontrolled systemic diseases like HTN, DM, RA, active neoplastic disease, ulceration, progressive gangrenous changes and any other autoimmune diseases like Rheumatoid arthritis, SLE etc will be excluded.
Pregnancy, lactation.
Patients Ayogya for Basti karma and Virechana karma
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in pain swelling and redness  8 days for both A & B groups 
 
Secondary Outcome  
Outcome  TimePoints 
changes in serum uric acid level  8 days for both A & B groups 
 
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   Phase 3 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 04/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
Introduction:
Vatarakta is a metabolic disorder in which vitiated Vata circulates through Srotas, and already Dushit rakta obstructs Vata and again agitate Vata, which further leads to Vatarakta. Here, in the present study considering Gout will be taken for the study. Initial symptoms usually consist of intense episodes of painful swelling in single joint.
As per Ayurveda, disease occurs due to aggravation of Vata along with Rakta resulting obstruction in metabolic pathways leading to the joint pain, restriction in movement and joint swelling etc. In the classics; Virechana karma and Basti karma are specially indicated in Bahudosha Avastha as a curative measure.
Significance:
2015-2016 worldwide the prevalence of gout was 3.9% among adults with 5.2% in men and 2.7% in women. This prevalence has been doubled since 1990s According to above data, it becomes a great concern how to deal with Gout and treat properly. Modern science is using quick acting NSAIDS & uricosuric to treat which have control over joint pain but have potential adverse effect.Only few number of research works are done on Vatarakta. Hence, an attempt has been made here to study Efficacy of Virechana followed by Bodhi Kashaya Yoga Basti and Virechana followed by Bodhi Kashaya pana in the management of Vatarakta w.s.r to Gout.
Aim & Objectives:
To evaluate and compare the efficacy Of Virechana followed by Bodhi Kashaya Yoga Basti and Virechana followed by Bodhi Kashaya Pana in the management of Vatarakta w.s.r. to Gout.
Materials and Methods:
30 Diagnosed or newly Diagnosed pt of Gout will be enrolled in two groups. Group A patients will receive intervention with Virechana with Aragwadha phala majja and Eranda taila followed by Yoga Basti with Bodhi kashaya Yastimadhwadi taila.Group B patients will receive Virechana with Aragwadha phala majja and Eranda taila followed by Bodhi kashaya Pana with Madhu.
Results and Discussion:
Data generated during the above study will be present in a Systemic manner as shall be analyzed statically. Where the important points of the Conceptual study, Analytical study, Pharmacological study will be discussed.
Follow up: After completion of therapy, follow up will be done after 30 day to assess the status of patient, where patient will be asked to report.
Adverse effects:
This drug have no known unwanted effects. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar.
 
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