FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/11/047191 [Registered on: 10/11/2022] Trial Registered Prospectively
Last Modified On: 04/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Kashmaryadi Kwath Virechana in treatment of Vatarakta (Gout) 
Scientific Title of Study   A clinical study to evaluate the efficacy of virechana karma with kashmaryadi kwath in the management of vatarakta (gout) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sunil Baloda 
Designation  MD Scholar 
Affiliation  UPGIAS&R, DSRRAU, Jodhpur 
Address  PG Department of Panchkarma, University Postgraduate Institute of Ayurved Studies and Research, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9950459737  
Fax    
Email  suneelbaloda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gyan Prakash Sharma 
Designation  HOD & Associate Professor 
Affiliation  UPGIAS&R, DSRRAU, Jodhpur 
Address  PG Department of Panchkarma, University Postgraduate Institute of Ayurved Studies and Research, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9829798701  
Fax    
Email  atreyagyan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sunil Baloda 
Designation  MD Scholar 
Affiliation  UPGIAS&R, DSRRAU, Jodhpur 
Address  PG Department of Panchkarma, University Postgraduate Institute of Ayurved Studies and Research, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University

Jodhpur
RAJASTHAN
342037
India 
Phone  9529181919  
Fax    
Email  suneelbaloda@gmail.com  
 
Source of Monetary or Material Support  
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur 
 
Primary Sponsor  
Name  Dr Sarvepalli Radhakrishnan Rajasthan, Ayurved University, Jodhpur 
Address  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Karwar, Nagaur Road, Jodhpur, Rajasthan Pin 342037 
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 Sunil Baloda  Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University University Hospital of Ayurved  OPD No 7 PG Department of Panchkarma Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin 342037
Jodhpur
RAJASTHAN 		 9950459737

suneelbaloda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, UPGIAS&R, Jodhpur  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
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak Samhita, Procedure details: Deepana & Pachana With Panchkola Churna For 3-7 Days, Snehapana With Guduchi Ghrit For 3-7 Days, Abhyanga & Swedana For 3 Days, Virechana Karma With Kashmaryadi Kwath For 1 Day, Samsarjana Karma For 3-7 Days.)
(1) Medicine Name: Kashmaryadi Kwath, Reference: Charak Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 2 Weeks
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Subjects presenting with clinical features of vatarakta.
2 Patient having chronicity less than 1 year.
3 Subjects of both sex between the age group of 20 to 60 years.
4 Patient having serum uric acid level above 5 mg/dl and presenting the sign and symptoms of vatarakta. 
 
ExclusionCriteria 
Details  1 Subjects with uncontrolled metabolic disorders and other systemic disorders
2 Subjects with autoimmune diseases of joints
3 chronicity for more than 1 year. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Subjective Parameters
1 Pain (Ruka) VAS Scale
2 Burning Sensation (Daha)
3 Malaise (Angmarda)
4 Local Colour Changes in the Skin

Objective Parameters
1 Tenderness (Sparshasahyata)
2 Edema (Shwayathu)
3 Walking Ability
4 Peripheral Pulses 		 45 Days 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the efficacy of treatment in 30 patients with the help of PAIN VAS SCALE, Burning Sensation (Daha), Malaise (Angmarda), Local Colour Changes in the Skin & Tenderness (Sparshasahyata), Edema (Shwayathu), Walking Ability, Peripheral Pulses.  45 days 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/11/2022 
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)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The variety of drugs like uricosuric, NSAIDS are used to treat the Gouty Arthritis symptomatically, which have many potential adverse effects like vomiting, G.I. bleeding, hepato renal toxicity etc. Hence I have taken this disease for study. There arises the need for the approach from Ayurveda to manage the “Vatarakta”. Due to rising technology, the human society is leading with mechanical life and is unable to follow the Dinacharya and Ritucharya which are explained in our science. Ayurveda aims at prevention and to cure diseases. With less burden of cost, defining the most effective treatment of Vatarakta is the need of the day. Internal medications, external medications and Panchkarma treatments are adopted for treating Vatarakta. The study is open labelled trial to prove the efficacy of virechana karma with kashmaryadi kwath in the management of vatarakta (gout). There is single group and no of patients are 30 
Close