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CTRI Number  CTRI/2023/09/057480 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 11/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management Of Vatarakta (Gout) Through Ayurveda  
Scientific Title of Study   A Clinical Evaluation Of Patoladi Kwatha In The Management Of Vatarakta (Gout)  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ali Mohmad 
Designation  Pg Scolar 
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Pg Department Of Kayachikitsa Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  6375146301  
Fax    
Email  aligbdc41@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Brahmanand Sharma 
Designation  Associate Professor  
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Pg Department Of Kayachikitsa Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9460318138  
Fax    
Email  bkmudgal9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Brahmanand Sharma 
Designation  Associate Professor  
Affiliation  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Pg Department Of Kayachikitsa Post Graduate Institute Of Ayurved Dr S R Rajasthan Ayurved University Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9460318138  
Fax    
Email  bkmudgal9@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute Of Ayurved Jodhpur 
 
Primary Sponsor  
Name  Post Graduate Institute Of Ayurved Jodhpur Rajasthan 
Address  Post Graduate Institute Of Ayurved Jodhpur DrS R Rajasthan Ayurved University Jodhpur 342037 
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 Ali Mohmad  Post Graduate Institute Of Ayurved Jodhpur  Kayachikitsa Department Room Number 6 Dr S R Rajasthan Ayurved University Jodhpur 342037
Jodhpur
RAJASTHAN 
6375146301

aligbdc41@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute Of Ayurved Institutional Ethics Committee   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 ArmDrugClassical(1) Medicine Name: Patoladi Kwatha, Reference: Chakradutta Vatarakta Chikitsa Prakarana 23/11, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients Between The Age Group Of 20-75 Years Of Either Sex Present With Clinical Features Of Vatarakta Well Diagnosed And Confirmed Case Of Vatarakta (Gout) Patients Having Serum Uric Acid Levels Of More Than 6 mg/dl To 12 mg/dl With Or Without Any Associated Features Like Joint Pain And Inflammation  
 
ExclusionCriteria 
Details  Patients Below 20 Years And Above 75 Years Will Be Excluded Pregnant And Lactating Mother Patients With Evidence Of Malignancy  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Assessment Of Subjective And Objective Parameters Before And After Treatment  6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To Observe Any Side Effects If Occur During Clinical Trial  45 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 3 
Date of First Enrollment (India)   21/09/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

INTRODUCTION

Vatarakta in Ayurveda is considered as one such chronic illness. Vatarakta, a common metabolic disorder is a grievous medical condition present in society. Vataraka as the name suggests is the vitiation of Vata Dosha and Rakta Dhatu (blood). In this condition the normal Flow of Vata is obstructed by Rakta Dhatu. This obstructed Vata again vitiates the Rakta,

this pathological state is known as Vatarakta. In Vatarakta mainly small joints of the feet and hands are affected. It is also called Khuddavata, Vatabalasaka, Adhyavata, Vatashonita etc.

Vatarakta is characterized by severe pain, tenderness, inflammation & burning sensation in the affected part of the body. Types of Vataraka include Uttana, Gambhira, Vata Pradhan, Pitta Pradhana, Kapha Pradhana and Rakta Pradhana.

 
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