| CTRI Number |
CTRI/2026/01/101166 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Compare Two Ayurvedic Treatment Procedures For Knee Osteoarthritis |
|
Scientific Title of Study
|
A Comparative Clinical Control Study Of Janubasti With And Without Asthishrunkhala Ksheer Basti In The Management of Janusandhigatvata W.S.R To Knee Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritu Rajesh Sawant |
| Designation |
MD Scholar |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital |
| Address |
Panchakarma Department Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9987317201 |
| Fax |
|
| Email |
sawantritu65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpana Gholap Dhomse |
| Designation |
HOD And Professor |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital |
| Address |
Panchakarma Department Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
|
| Email |
kalpu.gholap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Gholap Dhomse |
| Designation |
HOD And Professor |
| Affiliation |
Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital |
| Address |
Panchakarma Department Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9833971482 |
| Fax |
|
| Email |
kalpu.gholap@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurvedic Medical College And Hospital Kharghar |
|
|
Primary Sponsor
|
| Name |
Dr Ritu Rajesh Sawant |
| Address |
Panchakarma Department Dr G D Pol Foundation YMT Ayurvedic Medical College And Hospital Institutional Area Kharghar Navi Mumbai 410210 Raigarh Maharashtra 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 |
| Dr Ritu Rajesh Sawant |
YMT Ayurvedic Medical College And Hospital Kharghar |
Ground Floor Panchakarma OPD YMT Ayurvedic Medical College And Hospital Institutional area Sector 4 Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
9987317201
sawantritu65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr G D Pol Foundation YMT Ayurvedic Medical College And Charitable Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Siddhisthana Chapter 8 Shlok 4, Procedure details: Asthishrunkhala Ksheer Basti-
A)Purvakarma- Snehan With Dashmool Taila And Mrudu Nadi Sweda.
Preparation Of Basti- Asthishrunkhala Bharad-24gms,Godugdha-192ml,Murchit Til Taila-96ml,Murchit Goghrut-96ml,Madhu-96ml=480ml
B)Pradhankarma-Ask Patient To Pass Natural Urges.
Position-Patient lies In The Left Lateral Position,Right Leg Flexed & Left Leg Extended.
Lubricate The Catheter With Oil.Insert Gently Into The Rectum.Slowly Insert The Basti Dravya.Remove The Catheter Slowly And Instruct Patient To Lie Supine For Few Minutes.
C)Paschatkarma-Ask Patient To Retain The Basti For Maximum Duration.Give Light,Warm Food)
| | 2 | Comparator Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Acharya G.S. Panchakarma Illustrated, Procedure details: A)Purvakarma-Rogi Pariksha.
Materials-Black Gram Flour, Sahachar Oil,Bowl,Cotton.
B)Pradhankarma-Prepare A Dough Ring And Place It Around The Knee Joint.Seal The Edges To Prevent Leakage.Pour Warm Sahachar Oil Into The Ring.Maintain The Temperature By Replacing Or Reheating The Oil Continuously.
C)Paschatkarma-Remove The Oil And Dough .Wipe The Knee And Perform Mild Abhyanga. Advise Rest.)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed Case Of Sandhigatvata Based On Classical Ayurvedic Signs And Symptoms Sandhishool, Sandhishoth, Stambha, Akunchan Prasaran Vedana
2.Patients With Radiological Findings Of Osteoarthritis Grade 1 And Grade 2 Of Kellgren Lawrence Scale
3.Patients Of Either Sex
4.Patients Yogya For Basti |
|
| ExclusionCriteria |
| Details |
1.Patients With Severe Form of Systemic Disorders Like Uncontrolled Diabetes, Hypertension, Hypothyroidism
2.History Of Fracture Or Surgery On Knee Joint
3.Patients With Known Case Of Autoimmune Joint Disorders -RA,SLE
4.Pregnant Or Lactating Women
5.Patients With Radiological Findings Of Osteoarthritis Grade 3 And Grade 4 Of Kellgren lawrence Scale
6.Patients Agoya For Basti |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess The Efficacy Of Janubasti Combined with Asthishrunkhala Ksheer Basti In Reducing The Symptoms Sandhishool Shoth Stambha Akunchan Prasaran In The Management Of Janusandhigatvata |
Baseline , Day 15, Day 30, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyze The Effect Of Treatment Using Standard Tools Like VAS Scale, Range Of Motion By Goniometer |
Baseline, Day 15, Day 30, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
10/02/2026 |
| 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 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
|
Title - A Comparative Clinical Control Study Of Janubasti With And Without Asthishrunkhala Ksheer Basti In The Management Of Janusandhigatvata With Special Reference To Knee Osteoarthritis
Objectives- To Assess The Efficacy Of Janubasti Combined With Asthishrunkhala Ksheer Basti In Reducing The Symptoms Of Janusandhigatvata To Analyze The Effect Of Treatment Using Standard Tools Like VAS Scale Range Of Motion By Goniometer
Groups- Group A- Trial Group Janubasti With Asthishrunkhala Ksheer Basti Group B- Control Group Janubasti
Duration Of Procedure 15 Days
Name Of Student - Dr Ritu Rajesh Sawant Name Of Guide- Dr Kalpana Gholap Dhomse |