| CTRI Number |
CTRI/2026/04/108679 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
17/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Vataraktanashak Yoga And Kaishora Guggulu In Patients Of Hyperuricemia |
|
Scientific Title of Study
|
An Open-Label, Randomised, Comparative Clinical Study to Evaluate the Efficacy of
Vataraktanashak Yoga and Kaishora Guggulu in the Management of Vatarakta with Special
Reference to Hyperuricemia (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 |
Yash Nana Rathod |
| Designation |
PG Scholar |
| Affiliation |
APMS ayurved mahavidyalaya,sion |
| Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9834339988 |
| Fax |
|
| Email |
dryashrathod018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yash Nana Rathod |
| Designation |
PG Scholar |
| Affiliation |
APMS ayurved mahavidyalaya,sion |
| Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India
MAHARASHTRA
400022
India |
| Phone |
9834339988 |
| Fax |
|
| Email |
dryashrathod018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hemant Shridhar Paradkar |
| Designation |
Associate Proffesor |
| Affiliation |
APMS ayurved mahavidyalay,sion |
| Address |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9834339988 |
| Fax |
|
| Email |
hemant.paradkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| APMs Ayurved Mahavidyalaya,Seth R V Ayurvedic hospital,sion ,near sion railwa station,Sion East ,Mumbai ,Maharasthtra,India |
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurved Hospital |
| Address |
Near sion railway station,sion east,mumbai 400022 |
| Type of Sponsor |
Other [(charitable ayurvedic 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 |
| Yash Nana Rathod |
Seth RV Ayurvedic Hospital |
Department of Kayachikitsa, 4th floor, APMS Ayurved Mahavidyalaya, near Sion railway station, Sion East, Mumbai 22
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA |
9834339988
dryashrathod018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APM AYURVED MAHAVIDYALAYA SION |
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 | Other than Classical | | (1) Medicine Name: Vataraktanashak yoga, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: lukeworm water), Additional Information: -administered orally for 45 days with lukewarm water | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishora guggule, Reference: bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukeworm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 25 to 70 years.
Both male and female patients.
Clinically diagnosed cases of Vatarakta.
Serum uric acid: Males 7 to 12 mg per dL and Females 6 to 12 mg per dL.
Presence of at least two symptoms such as joint pain, swelling, stiffness, tenderness, or burning sensation |
|
| ExclusionCriteria |
| Details |
Chronic renal failure.
Pregnant and lactating women.
Rheumatoid arthritis.
HIV or HBsAg positive patients.
Chronic alcoholism.
Peripheral vascular disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in serum uric acid level from baseline to Day 45 and reduction in clinical symptoms such as joint pain, swelling, stiffness, tenderness, and burning sensation.
|
baseline and day 45
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in use of rescue medication, improvement in patient quality of life, and assessment of adverse events. |
Baseline,day45,and during follow up if applicable |
| improvement in clinical symptoms of vatarakta |
baseline and day 45 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/05/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is an open label randomized comparative clinical trial designed to evaluate the efficacy of Vataraktanashak Yoga and Kaishora Guggulu in the management of Vatarakta with special reference to gout. A total of 80 patients fulfilling the inclusion criteria will be randomly allocated into two groups with 40 patients in each group. Group A will receive Vataraktanashak Yoga and Group B will receive Kaishora Guggulu for a duration of 45 days. The primary outcome measures include change in serum uric acid levels and improvement in clinical symptoms such as joint pain, swelling, stiffness, tenderness and burning sensation. The study aims to evaluate the comparative effectiveness and safety of both interventions in the management of gout. |