| CTRI Number |
CTRI/2025/08/092929 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two Ayurveda milk-based enema in Gouty Arthritis |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy Of Trimisrita Ksheera Vasti (Yoga Vasti) versus Guduchyadi Ksheera Vasti (Yoga Vasti) In The Management Of Gouty
Arthritis (Vatarakta): A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSohan Lal Sao |
| Designation |
Pg Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Room no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
440001
India |
| Phone |
7999593841 |
| Fax |
|
| Email |
sohansao895@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSohan Lal Sao |
| Designation |
Pg Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Room no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
440001
India |
| Phone |
7999593841 |
| Fax |
|
| Email |
sohansao895@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Ade |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha |
| Address |
Room no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College
Hospital and Research Centre Hirapur Salod Wardha
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA
440001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre , Hirapur Salod Wardha, Maharashtra, India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 40 Department of Panchkarma Mahatma Gandhi Ayurved College Hospital
and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India |
| 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 Sohan Lal Sao |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 40 Department
of Panchkarma Mahatma
Gandhi Ayurved College
Hospital and Research
Centre Salod Hirapur
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
7999593841
sohansao895@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital And Research 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 | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sahastrayog, Procedure details: Trimisrita ksheer yog vasti )
(1) Medicine Name: Trimisrita ksheer yog vasti - Niruh 660ml Anuvasan vasti 100 ml , Reference: Sahastrayog, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 660(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Journal of ayurveda and integrated medical science , Procedure details: Guduchyadi ksheer yog vasti )
(1) Medicine Name: Guduchyadi ksheer yog vasti - Niruh vasti 660ml anuvasan vasti 100ml, Reference: Journal of ayurveda and integrated medical science , Route: Rectal, Dosage Form: Ksheerpaka, Dose: 660(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with hyperuricemia
Presenting with the following symptoms in sandhis (joints) of paada (foot) or hastha (hand) Toda (Pricking pain) Sparshasahyata (Tenderness) Daha (Burning sensation) Supti (Numbness) Shopha (Swelling), Raaga (discoloration)
Patients of either sex, aged 25 to 70 years.
Patients with chronicity of disease less than 10 years
Patients fit for Vasti Karma (Vasti Yogya)
Serum uric acid ranges from 6.00 mg/dl to 9.00 mg/dl. |
|
| ExclusionCriteria |
| Details |
Cases of Kochs arthritis
Patients diagnosed with Septic arthritis
Individuals having Chronic renal failure
Those suffering from Severe systemic Multiorgan syndromes
The patients unfit for Vasti Karma (Vasti Ayogya) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess And Compare The Efficacy Of Trimisrita Ksheera Vasti (Yoga Vasti) versus Guduchyadi Ksheera Vasti (Yoga Vasti) In The Management Of Gouty Arthritis (Vatarakta): A Randomized Controlled Trial |
at baseline 9 day
24 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and Assessment of Efficacy Of Trimisrita Ksheera Vasti (Yoga Vasti) versus Guduchyadi Ksheera Vasti (Yoga Vasti) In The Management Of Gouty Arthritis (Vatarakta): A Randomized Controlled Trial |
at baseline 1 Week 2 day
3 Weeks 3 days
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
17/09/2025 |
| 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="2"
Months="0"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 8 days treatment period and at Day follow up period 0th, 9th and 24th day. |