| CTRI Number |
CTRI/2025/06/088137 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The management of Janu sandhigatavata (Osteoarthritis of knee joint ) with the external application of Tintrini Swarasadi Taila Janu basti. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of tintrini swarasadi taila janu basti in the management of sandhigatavata w. s. r. to janu sandhi. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balasaheb Damu Chavan |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant ayurvedic college post graduate training and research
centre, panchkarma department OPD Kodoli, Tal. Panhala, Dist.
Kolhapur, State Maharashtra, 416114, India.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8380837089 |
| Fax |
|
| Email |
balasahebchavan33bc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ingavale Abhijeet Subhashrao |
| Designation |
Reader |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre, Panchkarma Department OPD Kodoli, Tal. Panhala Dist.
Kolhapur, State.Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822919000 |
| Fax |
|
| Email |
abhijeetingavale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Balasaheb Damu Chavan |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college post graduate training and research centre, Kodoli. |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre, Panchkarma Department OPD Kodoli, Tal. Panhala Dist.
Kolhapur, State.Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8380837089 |
| Fax |
|
| Email |
balasahebchavan33bc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Kodoli Tal
Panhala Dist Kolhapur 416114
|
|
|
Primary Sponsor
|
| Name |
Dr BALASAHEB DAMU CHAVAN |
| Address |
Panchkarma OPD and Ipd Ground floor Panchakarma dept
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Kodoli Tal Panhala Dist Kolhapur 416114 |
| 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 Balasaheb Damu Chavan |
Yashwant Dharmartha Rugnalay |
Yashwant Ayurvedic College Post GraduateTraining and Research Centre, Kodoli Panchkarma OPD Ground floor and IPD Second floor, Room No. 4 Panchakarma department. Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA |
8380837089
balasahebchavan33bc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tintrini Swarasadi Taila , Reference: Sahasrayogam, by Dr. Ramniwas Sharma & Dr. Surendara Sharma. Chowkhamba Sanskrit Series Office Varanasi Tailprakarn 3 ,Page no.88 , Route: Topical, Dosage Form: Taila, Dose: 400(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: Matra :- As per needed
Kala :- 45 min
Temperature :- Sukoshna Taila | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ksheerbala Taila , Reference: Sahasrayogam, by Dr. Ramniwas Sharma & Dr. Surendara Sharma. Chowkhamba Sanskrit Series Office Varanasi Tailprakarn 3 ,Page no.102 , Route: Topical, Dosage Form: Taila, Dose: 400(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -matra :- As per needed
Kala :- 45 min
Temperature :- Sukoshna Taila |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having sign & symptoms Shoola, Akunchana Prasaranjanya Vedana of janu sandhigatavata. |
|
| ExclusionCriteria |
| Details |
1. K/H/O Janusandhigata Aaghat (Trauma on knee joint).
2. K/H/O Congenital abnormalities and other structural deformities of Janusandhi.
3. K/H/O Severe Systemic illness.
4. Patient not willing for trial.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Tintrini Swarasadi Taila janu basti in the management of sandhigata vata w. s. r. to janu sandhi. assessing subjective parameters such Shoola, Akunchana Prasaranjanya Vedana of janu sandhigatavata. |
14 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study Janusandhigata vata in detail from various ayurvedic texts
To reduce sign and symptoms of sandhigata vata.
To assess the improvement by sign and symptoms and gradation of
assessment criteria.
To study etiopathology clinical manifestation of sandhigata vata.
To improve quality of life and reduce discomfort of patients.
To achieve the outcome of study in 14 days. |
14 Days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 |
|
Date of First Enrollment (India)
|
08/06/2025 |
| 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)
|
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
|
This is an Randomized open controlled clinical study to evaluate the efficacy of Tintrini Swarasadi taila Janu basti in the management of Sandhigatavata w. s. r. to Janu sandhi.”
The assesment of signs and symptoms will be done at regular follow ups. Observation will be drawn from the outcomes achieved in 14 days. |