| CTRI Number |
CTRI/2010/091/001079 [Registered on: 14/09/2010] |
| Last Modified On: |
02/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to asses efficacy of mustard pack on osteoarthritis of knee |
|
Scientific Title of Study
|
A randomized wait list controlled clinical trial to study the effect of mustard pack application in patients of osteoarthritis of knee. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| INYS-MRS-OA-MP-10 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Babina.N |
| Designation |
|
| Affiliation |
|
| Address |
INYS-MRS,Jindal nagar
Tumkur road
Bangalore
KARNATAKA
560073
India |
| Phone |
080 - 23717777 |
| Fax |
080 - 23717785 |
| Email |
dr.babina@jindalnaturecure.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Babina.N |
| Designation |
|
| Affiliation |
joint CMO |
| Address |
INYS-MRS,Jindal nagar
Tumkur road
Bangalore
KARNATAKA
560073
India |
| Phone |
080 - 23717777 |
| Fax |
080 - 23717785 |
| Email |
dr.babina@jindalnaturecure.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Babina.N |
| Designation |
|
| Affiliation |
|
| Address |
INYS-MRS,Jindal nagar
Tumkur road
Bangalore
KARNATAKA
560073
India |
| Phone |
080 - 23717777 |
| Fax |
080 - 23717785 |
| Email |
dr.babina@jindalnaturecure.org |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Yoga & Naturopathy
1-65, Institutional Area, Janakpuri, New Delhi - 110058 (India)
Ph : 011-28520430,31,32 |
| Institute of Naturopathy and Yogic Science Medical Research Society (INYSMRS).Jindal Nagar.Tumkur Road-Bangalore-73 |
|
Primary Sponsor
Modification(s)
|
| Name |
CCRYN |
| Address |
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
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.Mahesh |
INYS-MRS.Jindal Charitable Hospital |
Rajaji Nagar ,-
Bangalore
KARNATAKA |
ma.ka.drs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INYS ethics commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
kNEE JOINT OSTEOARTHRITIS, osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mustard pack application on knee |
once daily for 30 days |
| Comparator Agent |
no control intervention-waitlist control |
waitlist for 30 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Documented radiographic changes of osteoarthritis
2. Kellgren Lawrence grade >2
3. pre randomization VAS score between 4 to 9
|
|
| ExclusionCriteria |
| Details |
1. Rheumatoid Arthritis,Fibromyalgia,Recurrent Or Active Pseudo Gout
Cancer or Other Serious Medical Condition
2. History of kidney liver failure
3. oral steroids within last four weeks
4. Intra articular knee depo-corticosteroids within previous 3 months
5. significant knee injury in previous 6 months
6. open wound over knee
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOMAC Score.pain -VAS,50 feets walking time,range of movements -gioniometery. |
base line ,week 2 and week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life changes |
base line,week 2 nad week 4 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
12/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized waitlistcontrolled study.Subjects will be randomly allotted to two groups.the study group will receive mustard pack therapy from the day of recruitment,where as the waitlisted control group will be given advice on lifestyle measures about management of disease.they will get the treatment with mustard pack after a waitlist period of one month (equal to treatment period of study group).Subjects in both the groups will be allowed to take NSAID prescribed by their orthopedic surgeon as a rescue medication.Need of rescue medication in both the groups will be taken as a parameter for comparison of outcome. |