| CTRI Number |
CTRI/2025/01/079112 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic trial for treatment of Knee Osteoarthritis |
|
Scientific Title of Study
|
Comparative study to evaluate the efficacy of Janubasti with Erand Taila and Ksheerbala Taila in the management of Janu Sandhigata Vata(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 |
Kartik Pokhriyal |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no. 123,Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Khera Dabar South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
8700823251 |
| Fax |
|
| Email |
kartikpokhriyal.bb5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Arun Gupta |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no. 142,Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Khera Dabar South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
08178361290 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Arun Gupta |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no. 142,Chaudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar Khera Dabar South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
08178361290 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh South West Delhi 110073 India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najaafgarh New Delhi 110073 |
| Type of Sponsor |
Government 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 |
| Prof Dr Arun Gupta |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no. 142, PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar South West Delhi 110073 India
South West
DELHI |
08178361290
arun24@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to participate in the study with written and informed consent, Classical sign and symptoms of sandhigata vata such as shoola, shotha, stambha, sparsha asahyata, sphutana, akunchana evam prasarana vedana at the janusandhi, Patients with radiological findings of Janu Sandhigata Vata(Knee Osteoarthritis) and Patients fit for janubasti |
|
| ExclusionCriteria |
| Details |
Patients below 40 and above 60 years of age, Patients suffering from uncontrolled hypertension and uncontrolled diabetes, Patients suffering from diseases like Carcinoma, Psoriatic arthritis, Gout, S.L.E., Polymyalgia rheumatica and Tuberculosis etc. and patients unfit for Janubasti |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Janubasti with Erand Taila may show improvements in Western Ontario and McMaster Universities Osteoarthritis Index, Visual Analogue Scale Score |
0th day, 15th day and 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Janubasti with Erand Taila may show improvements in classical Symptoms Of Janu Sandhigata Vata like shooola, shotha, sparsha asahyata, sandhi sphutana, sandhigraha. |
0th day, 15th day and 30th day. |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
01/02/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is a randomized control trial to evaluate the effect of Janubasti with Erand Taila in the management of classical symptoms of Janu Sandhigata Vata when compared to Janubasti with Ksheerbala Taila.In one group, Janubasti will be given with Erand Taila . The first assessment on 0th day, the second assessment on procedure completion 15th day, and follow up on 30th day. While in second group, Janubasti will be given with Ksheerbala Taila. The first assessment on 0th day, the second assessment on procedure completion 15th day, and follow up on 30th day. Patients will be enrolled in OPD and IPD of PG Department of Panchakarma, Ch. Brahm Prakash Ayurved Charak Sansthan. Janubasti with Erand Taila may show better results in reducing classical symptoms Janu Sandhigata Vata like shoola and shotha. WOMAC OA Index and VAS Scale are expected to be observed. |