| CTRI Number |
CTRI/2025/02/081087 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchakarma Matra Basti] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of trimishrak taila matra basti in management of vatarakta |
|
Scientific Title of Study
|
Open randomised control clinical trial of trimishrak taila matra basti in vatarakta with special reference to 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 |
DrNayan Ashok Dhadel |
| Designation |
PG Scholar |
| Affiliation |
Hon.Shri Annasaheb Dange Ayurvedic Medical College Post Graduate And Research Centre |
| Address |
At Post Wadiratnagiri,Jotiba Tal.Panhala, Dist. Kolhapur
Opd no 09,Panchakarma OPD,ground floor,Dhanvantari ayurveda
hospital Ashta, Tal Walwa Dist Sangli Opd no 09, Panchakarma
OPD,ground floor,Dhanvantari ayurveda hospital Ashta, Tal Walwa
416301
Sangli
MAHARASHTRA
416229
India |
| Phone |
9284636272 |
| Fax |
|
| Email |
nayandhadel02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArchana Wadkar |
| Designation |
Associate Professor |
| Affiliation |
Hon.Shri Annasaheb Dange Ayurvedic Medical College Post Graduate And Research Centre |
| Address |
Vishrambag Sangli
Opd no 09,Panchakarma OPD,ground floor,Dhanvantari ayurveda
hospital Ashta, Tal Walwa Dist Sangli Opd no 09,Panchakarma
OPD,ground floor,Dhanvantari ayurveda hospital Ashta, Tal Walwa
416301
Sangli
MAHARASHTRA
416415
India |
| Phone |
9423248506 |
| Fax |
|
| Email |
archanaswadkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrArchana Wadkar |
| Designation |
Associate Professor |
| Affiliation |
Hon.Shri Annasaheb Dange Ayurvedic Medical College Post Graduate And Research Centre |
| Address |
Vishrambag Sangli
Opd no 09,Panchakarma OPD,ground floor,Dhanvantari ayurveda
hospital Ashta, Tal Walwa Dist Sangli Opd no 09,Panchakarma
OPD,ground floor,Dhanvantari ayurveda hospital Ashta, Tal Walwa
416301
Sangli
MAHARASHTRA
416415
India |
| Phone |
9423248506 |
| Fax |
|
| Email |
archanaswadkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangali Maharashtra 416301 india |
|
|
Primary Sponsor
|
| Name |
Dr Nayan Ashok Dhadel |
| Address |
OPD no 09 Panchakarma OPD Ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangali Maharashtra 416301 india |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| DrNayan Ashok Dhadel |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Centre |
OPD no 09 Panchakarma OPD Ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa
Sangli
MAHARASHTRA |
9284636272
nayandhadel02@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Ashta 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 | Comparator Arm | Procedure | - | Matra Basti | (Procedure Reference: Ashtang Hridyam , Procedure details: Matra Basti one time in day for 8 days )
(1) Medicine Name: Draksharasa siddha taila , Reference: Charak samhita , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | Matra Basti | (Procedure Reference: Ashtang Hridyam , Procedure details: Matra Basti one time in day for 8 days )
(1) Medicine Name: Trimishrak Taila , Reference: Sahastrayog , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having sign & symptoms of Vatarakta
2.Patient indicated for Matra Basti
3.Patient with or without elevated uric acid level but diagnosed with gout with respect clinical sign & symptoms. |
|
| ExclusionCriteria |
| Details |
1.Patient contraindicated for Matra Basti
2.Pregnant women
3.Patient diagnosed with any other systemic illness which are fatal & chronic in nature |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Trimishrak Taila Matra Basti in Vatarakta |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Trimishrak Taila Matra Basti & Draksharasa Siddha Taila Matra Basti in management of Vatarakta |
1 month |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
In this modern era, incidence of patient suffering from Vatarakta are increasing on steady pace due to changes in their lifestyle. Vatarakta is a metabolic disorder in which both vata & rakta afflicted by distinct etiological factors. Lakshanas of Vatarakta vyadhi are sandhi shool,sandhi toda,sandhi sthambha,sandhi vaivarnya,sparshaasahatva.In modern science it may be correlated with Gout. Prevalence rate of gout in India 0.2 to 3.5% per 1000 people. In charak chikitsa sthan, chikitsa for Vatarakta disease are snehayukta virechan or ruksha mrudu virechan,Raktamokshan,Basti etc. Out of which Basti is easier, cost effective & comfortable treatment for Vatarakta. Various studies are completed in Vatarakta but no any work done on Trimishrak Taila Matra Basti in Vatarakta which is mentioned in Sahastra Yoga is selected for study.
|