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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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. |