| CTRI Number |
CTRI/2023/10/058616 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to see the effect of Janu Dhara karma and traction in the patients of knee joint pain |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Role of Janu Dhara With Parijaat Tail & Manual Traction In Janusandhigata Vata ( Osteoarthritis Of Knee Joint )
|
| 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 Sandeep Kumar |
| Designation |
MD sholar |
| Affiliation |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur |
| Address |
PG Department of Panchkarma, Post graduate institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University karwar
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9983668599 |
| Fax |
|
| Email |
sandeepbams21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar |
| Designation |
MD sholar |
| Affiliation |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur |
| Address |
PG Department of Panchkarma, Post graduate institute of Ayurveda, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University karwar
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9983668599 |
| Fax |
|
| Email |
sandeepbams21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Associate Professor and HOD |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur |
| Address |
PG Department of Panchkarma, Post Graduate Institute of Ayurveda, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University karwar, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda, Jodhpur , RAJASTHAN |
| Address |
Post Graduate Institute of Ayurved, Dr. Sarvepalli Radhakrishnan
Rajasthan Ayurved University, Nagaur Road, Karwad, Jodhpur
Rajasthan 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sandeep Kumar |
Post graduate institute of Ayurveda Jodhpur |
P.G Department of
Panchakarma(OPD
no-7), Post Graduate
Institute of Ayurved, Dr.
Sarvepalli
Radhakrishnan
Rajasthan Ayurved
University, Nagaur
Road, Karwad,
342037 India
Jodhpur
RAJASTHAN |
9983668599
sandeepbams21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur. Post Graduate Institute Of Ayurveda. Institutional Ethics Committee |
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 | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Astanda hridaya Sutrasthana 22, Procedure details: Patient will sit in comfortable position in droni with legs extended. The bowel containing oil will be heated gently by keeping over hot water. Sukhosna tail will be poured in dhara patra or Clean sponges will be dipped in sukhosna tail and squeezed by right mist and made to flow on knee joint in regular stream with dhara patra or along with the direction of inverted thumb.The height of stream is maintained about 4 angula (Approx. 8 inches ) throughout the procedure. Mild massage will be given )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a)Confirmed cases of janusandhigata vat
b)Patients between the age group of 20-70 years of either sex.
c) Clinically fit for jaanudhara.
d) Patient without malignancy or patient without going through treatment.
e) Subjects willing to follow the procedures as per the study protocol and voluntarily sign an
informed consent proforma |
|
| ExclusionCriteria |
| Details |
a) Pregnant and lactating woman.
b) Subjects contra-indicated for janudhara.
c) Patients suffering with other systemic chronic disorders like Malignancy, Cardiac and
Renal disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce knee joint pain
To reduce knee joint stiffness |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve the quality of life |
60 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)
|
11/12/2023 |
| 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 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 study is single arm, an open label trial , with single group of 30 patients to assess the efficacy of Janu Dhara with Parijaat tail & Manual traction in management of Janusandhigata Vata (Osteoarthritis of Knee Joint). The primary objective of present study is reducing subjective parameter using KOOS Score. Parijaat taila janudhara along with manual traction for 15 days will be given for present study. Follow up will be done on16th, 30th, 45th and 60th day of treatment.
|