| CTRI Number |
CTRI/2020/01/022622 [Registered on: 06/01/2020] Trial Registered Prospectively |
| Last Modified On: |
03/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Indravaruni Yoga & Mulaka Taila in the management of osteoarthritis of knee joint |
|
Scientific Title of Study
|
A clinical study of Indravaruni Yoga & Mulaka Taila in degenerative Osteoarthritis W.S.R. of Sandhigata Vata |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arti jain |
| Designation |
Post graduation scholar |
| Affiliation |
Govt Dhanwantri Ayurvedic medical college and hospital |
| Address |
111 Seniour MIG Mehta mention Indira nagar Ujjain
Govt Dhanwantri Ayurvedic medical college and hospital Mangalnath Road
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9977517379 |
| Fax |
|
| Email |
draartijain24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NARESH JAIN |
| Designation |
Associate professor |
| Affiliation |
Govt Dhanwantri Ayurvedic medical college and hospital |
| Address |
1 st floor Kayachikitsa department Govt Dhanwantri Ayurvedic medical college Mangalnath Road
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9826064756 |
| Fax |
|
| Email |
nareshjainujn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NARESH JAIN |
| Designation |
Associate professor |
| Affiliation |
Govt Dhanwantri Ayurvedic medical college and hospital |
| Address |
1 st floor Kayachikitsa department Govt Dhanwantri Ayurvedic medical college Mangalnath Road
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9826064756 |
| Fax |
|
| Email |
nareshjainujn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Dhanwantari Ayurvedic College and Hospital Ujjian |
|
|
Primary Sponsor
|
| Name |
Govt Dhanwantari Ayurvedic College and Hospital Ujjian |
| Address |
Mangalnath Road Ujjain Madhya Predesh |
| 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 |
| Arti Jain |
Govt Dhanwantari Ayurvedic Hospital |
OPD No. 27 Kayachikitsa Department Govt Dhanwantari Ayurvedic Hospital Chiman Ganj Thane Ke Pichhe
Ujjain
MADHYA PRADESH |
9977517379
draartijain24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee Govt Dhanwatari Ayurvedic college and Hospital |
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 |
| Intervention |
1.Indravaruni Yoga with Mulaka Taila orally
2.Indravaruni Yoga per oral with Mulaka Taila for Local Application |
1.Indravaruni Yoga with lukewarm water 3 gm /BD after meal for 8 weeks along with mulaka taila 10 ml /OD with warm milk in morning daily for 8 weeks in sandhigata vata
2.Indravaruni Yoga with lukewarm water 3 gm /BD after meal for 8 weeks along with Mulaka Taila used in locally Abhyanga swedana daily for 8 weeks in sandhigata vata .
|
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients Presenting with Classical sign and Symptoms of Sandhigata Vata |
|
| ExclusionCriteria |
| Details |
Patients below 40 year and above 70 years of age
Pregnant women and lactating women
Associated with Trauma
Associated with other systemic or metabolic disorder |
|
|
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 |
| Change in classical sign & symptoms of Sandhigata vata (At the time of baseline & at the end of the treatment) |
Total study period 12 months
Treatment period 2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in physical function domain
Change in K L grading score( At the time of baseline & at the end of the treatment )
Assessment of change in the clinical parameters (on 0,15th,30th,45th and 60th day)
|
Total study period 12 months
Treatment period 2 months
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/01/2020 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study
is a randomized interventional clinical trial to evaluate the effect of
Indravaruni Yoga and Mulaka Taila in the management of degenerative
osteoarthritis W.S.R. Sandhigata vata. Total 40 patients will be enrolled in
present study. Selected patients will be divided in two groups on the basis of
computer generated randomization.
GROUP A 20 patients will be given Indravaruni
Yoga with lukewarm water 3 gm /BD
after meal, with orally Mulaka Taila 10ml / OD with war milk in morning daily for
8 weeks
GROUP B 20 patients will be given
Indravaruni Yoga with lukewarm water 3 gm /BD after meal with Mulaka Taila used in locally Abhyanga swedan
daily for 8 weeks will be given and efficacy compared with palliative
conservative medicine for degenerative osteoarthritis W.S.R. Sandhigata vata or
in follow up in degenerative
osteoarthritis W.S.R. Sandhigata vata. |