| CTRI Number |
CTRI/2025/10/095637 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In this study patients with Degenerative Joint Diseases Sandhigatavata will be selected for MATRA BASTI using VARAHA VASA to check its effects |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFECT OF VASA MATRA BASTI IN
THE MANAGEMENT OF DEGENERATIVE JOINT DISEASES W S R TO
DHATUKSHAYAJANYA SANDHIGATAVATA |
| Trial Acronym |
Vasa Matra Basti |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Pitre Neeraja Vasudev |
| Designation |
PG Scholar |
| Affiliation |
SDM COLLEGE OF AYURVEDA HOSPITAL AND RESEARCH CENTER |
| Address |
Department of Panchakarma
SDM College of AyurvedaHospital and Research Centre
Laxminagar Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9325222408 |
| Fax |
|
| Email |
neeru.pitre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Niranjan Rao |
| Designation |
HOD and Vice Principal |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Laxminagar Kuthpady Udupi |
| Address |
Department of Panchakarma
SDM College of Ayurveda Hospital and Research Centre
Laxminagar Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448835203 |
| Fax |
|
| Email |
rao.drniranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niranjan Rao |
| Designation |
HOD and Vice Principal |
| Affiliation |
SDM College of Ayurveda Hospital and Research Centre Laxminagar Kuthpady Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre
Laxminagar Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448835203 |
| Fax |
|
| Email |
rao.drniranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda Hospital and Research Centre
Laxminagar Kuthpady Udupi |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda Hospital and Research Centre Udupi |
| Address |
SDM College of Ayurveda Hospital and Research Centre
Laxminagar Kuthpady Udupi
574118 |
| Type of Sponsor |
Private medical college |
|
|
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 Pitre Neeraja Vasudev |
SDM College of Ayurveda Hospital and Research Centre |
Laxminagar Kuthpady Udupi 574118
Udupi
KARNATAKA |
9325222408
neeru.pitre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE- HUMAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: CHARAKA SAMHITA, Procedure details: MATRA BASTI WITH VARAHA VASA)
(1) Medicine Name: VARAHA VASA, Reference: CHARAKA SAMHITA, Route: Rectal, Dosage Form: Not Applicable, Dose: 30(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnostic criteria
Symptoms of Degenerative Joint Disease / Sandhigata vata (Dhatukshayajanya) present like
Shoola
Vata poorna driti Sparsha
Shotha
Prasarana akunchana Vedana
Atopa
Inclusion criteria
Patients fulfilling the diagnostic criteria of Degenerative Joint Disease / Sandhigata
vata (Dhatukshayajanya)
Patients age between 50-70 years
Patients fit for Sneha basti |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients with any systemic illness that affects the procedure
Patients with age less than 50 years |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assesment of Symptoms of Degenerative Joint Disease / Sandhigata vata
(Dhatukshayajanya)
Assessment of Samyak yoga lakshana of anuvasana basti |
0, 8 AND 16 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Criteria for clinical diagnosis of Osteoarthritis |
0, 8 AND 16 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/10/2025 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 IS AN OPEN LABEL RANDOMISED CLINICAL STUDY TO EVALUATE THE EFFECT OF VASA MATRA BASTI IN THE MANAGEMENT OF DEGENERATIVE JOINT DISEASES W.S.R. TO SANDHIGATA VATA. IN THIS STUDY MINIMUM OF 30 PATIENTS DIAGNOSED WITH DEGENERATIVE JOINT DISEASE ARE SELECTED BASED ON THE DIAGNOSTIC AND INCLUSION CRITERIA. THE PRIMARY OUTCOMES OF THE STUDY ARE SAMYAK YOGA LAKSHANAS OF ANUVASANA BASTI. THE SECONDARY OUTCOMES ARE CRITERIA FOR CLINICAL DIAGNOSIS OF OSTEOARTHRITIS ON 0, 8 AND 16 DAYS. |