| CTRI Number |
CTRI/2019/12/022217 [Registered on: 02/12/2019] Trial Registered Prospectively |
| Last Modified On: |
24/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Rhumed strong oil in Osteoarthritis of Knee Joint |
|
Scientific Title of Study
|
An open labeled interventional clinical trial to evaluate the efficacy of Rhumed strong oil in the management of Osteoarthritis of knee joint. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Panchakarma National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmagal108@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Karunanidhi Sharma |
| Designation |
Research officer |
| Affiliation |
Multani Pharmaceutical Ltd |
| Address |
OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda, Jaipur 302002, Rajasthan
OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda, Jaipur 302002, Rajasthan
New Delhi
DELHI
110020
India |
| Phone |
9818850080 |
| Fax |
|
| Email |
vdkarunanidhi.sharma@multani.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Himanshu S Tiwari |
| Designation |
Medical advisor |
| Affiliation |
Multani Pharmaceutical Ltd |
| Address |
OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda, Jaipur 302002, Rajasthan
OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda, Jaipur 302002, Rajasthan
New Delhi
DELHI
110020
India |
| Phone |
9654350714 |
| Fax |
|
| Email |
dr.hstiwari@multani.org |
|
|
Source of Monetary or Material Support
|
| Multani Pharmaceuticals Ltd., New Delhi |
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Ltd New Delhi |
| Address |
Address T-10
Okhla industrial area
Phase II
Okhla New Delhi 110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gopesh Mangal |
National Institue of Ayurveda |
OPd room no 2 and IPD of Panchakarma Department , National Institute of Ayurveda
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe NIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Rhumed strong oil |
Oil will be locally applied for 10 minutes to the affected joint/s twice day for 15 days. Dose 10-15 ml for external use |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age: from 40-70 years of either sex
Subjects with symptoms of Osteoarthritis of knee joint
Subjects who are willing to give informed consent any ready to comply the protocol
Subjects who are ready to provide regular follow up till the completion of the study
|
|
| ExclusionCriteria |
| Details |
Patients of age below 40 years and above 70 years of either sex
Patients having associated Pulmonary Tuberculosis, Burns, Open wounds and infective conditions, allergy, skin sensitivity , Knee joint replacement, Gouty arthritis, Rheumatoid arthritis etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the degree of swelling, stiffness, restricted movement of the joints, tenderness and development of any adverse effect |
one year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
11/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not any |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
It is an open labeled, single armed, single center, prospective, interventional clinical study to evaluate the efficacy of the Rhumed strong oil on 50 patients suffering from osteoarthritis of knee joint. The study will be conducted in Panchakarma department, NIA, Jaipur, Rajasthan. It will be advised to subjects to apply the oil 2 times a day on the affected knee joint/s for 15 days. The primary outcome measure will be to assess the efficacy of Rhumed strong oil in patients of Joints pain by assessing the degree of pain on day 0, day 15 and day 22. The secondary outcome will be assess the changes in swelling, tenderness, stiffness and restricted movement in joint.
|