| CTRI Number |
CTRI/2025/10/096304 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the Role of Amritadi Kwath and Trivrittadi Kwath in the Management of Gout (Vatarakta) |
|
Scientific Title of Study
|
A comparative clinical evaluation of amritadi kwath and trivrittadi kwath in the management of vatarakta w.s.r.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 |
Manju Saini |
| Designation |
PhD Scholar |
| Affiliation |
Guru Ravidas Ayurved University |
| Address |
Govt Ayurvedic College, Moti bag Road Patiala Punjab
VPO Kharkan,Una road,Hosiarpur,Punjab 146110
Patiala
PUNJAB
147001
India |
| Phone |
09417708920 |
| Fax |
|
| Email |
manjusaini79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. AMITABH SINGH |
| Designation |
PROFESSOR |
| Affiliation |
Desh Bhagat University Mandi Gobindgarh |
| Address |
Room No. 3, Deptt of kayachikitsa,Opd block ,ground floor,Desh BhagatAyurvedic college Mandi Gobindgarh Distt Fatehgarh Sahib
Off to NH 44,Amloh road,Mandi gobindgath,Distt.Fatehgarh sahib,Punjab 147301
Patiala
PUNJAB
147301
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
dr.s.d.pandey123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. S.D. Pandey |
| Designation |
PROFESSOR |
| Affiliation |
Desh Bhagat University Mandi Gobindgarh |
| Address |
Room No. 3, Department of kayachikitsa,opd block,ground floor,Desh Bhagat Ayurvedic college, Mandi Gobindgarh Distt Fatehgarh Sahib
Off to NH 44,Amloh road,Mandi gobindgarh, distt Fatehgarh sahib,Punjab 147301
Patiala
PUNJAB
147301
India |
| Phone |
9872583155 |
| Fax |
|
| Email |
dr.s.d.pandey123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self sponsered |
| Address |
Govt Ayurvedic Collge Patiala
147001 |
| Type of Sponsor |
Other [self sponsered phd study] |
|
|
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 |
| Manju Saini |
Govt Ayurvedic Hospital |
Room No. 7 Kayachikitsa OPD, OPD Block, Ground Floor, Shere Punjab Market, Patiala
Patiala
PUNJAB |
9417708920
manjusaini79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Desh Bhagat Univesity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadi Kwatha, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TRIVRITADI KWATHA, Reference: BHAVPRAKASH, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to participate in the trial
2. Patients between the age group of 20 years -65 years.
3. Patients having serum uric acid more then 7mg/dl in males and more then 6mg/dl in females with symptoms of Vatrakta |
|
| ExclusionCriteria |
| Details |
1. Patients who do not consent to participate in the trial.
2. Patients below the age of 20 and above 65 years of age.
3. Patients with asymptomatic hyperuricemia and suffering from Secondary gout.
4. Patients suffering from chronic respiratory, cardiac, hepatic, renal and hormonal disorders
5. Pregnancy and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms like Pain, redness, swelling, stiffness, Burning in Joints, Reduction in serum uric acid level |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the frequency of attack of vatrakta |
30 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/11/2025 |
| 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)
|
Not Applicable |
| 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
|
The present clinical study titled “A Comparative Clinical Evaluation of Amritadi Kwatha and Trivrittadi Kwatha in the Management of Vatarakta w.s.r. to Gout” aims to evaluate and compare the therapeutic efficacy of two classical Ayurvedic formulations, Amritadi Kwatha and Trivrittadi Kwatha, in the management of Vatarakta (Gout). Vatarakta is a metabolic disorder correlated with gout in modern medicine, characterized by hyperuricemia and deposition of urate crystals in joints, leading to pain, swelling, and inflammation. This interventional comparative clinical trial will include 120 patients diagnosed with Vatarakta, divided into two groups of 60 each. Group I will receive Amritadi Kwatha 20 ml twice daily, and Group II will receive Trivrittadi Kwatha 20 ml twice daily for 30 days, with follow-ups on the 15th, 30th, and 60th days. The study aims to assess improvement in clinical symptoms and serum uric acid levels to identify an effective, safe, and affordable Ayurvedic management approach for Vatarakta (Gout). |