| CTRI Number |
CTRI/2017/09/009752 [Registered on: 13/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of the effect of Janu basti(exeternal oleation through a specialized method) and Matra basti(internal oleation using enema) in the management of osteoarthritis Of knee joints |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the role of Janu basti and Matra basti along with Adityapaka guggulu in the management of Janu sandhigata Vata ws.r. to 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 Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
P.G. Department of Panchakarma, National Institute of Ayurveda,Jorawar singh Gate,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvesh Kumar Singh |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
P.G. Department of Panchakarma, National Institute of Ayurveda,Jorawar singh Gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kumar |
| Designation |
P.G. scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
P.G. Department of Panchakarma, National Institute of Ayurveda,Jorawar singh Gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7597385005 |
| Fax |
07597385005 |
| Email |
miglani85@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jorawar singh Gate,Amber road, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda,Jorawar singh Gate, Jaipur |
| 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 |
| Dr Sarvesh Kumar Singh |
National Institute of Ayurveda Jaipur |
Department of Panchakarma,National Institute of Ayurveda,Jorawar Singh Gate Jaipur
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, National institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
osteoarthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Janu Basti with Sahachara Taila for 14 days along with oral administration of Adityapaka Guggulu tablets twice a day for 30 days |
Janu Basti will be done with Sahachara Taila for 14 days along with oral administration of Adityapaka Guggulu tablets twice a day for 30 days in 15 patients |
| Comparator Agent |
Matra Basti with Sahachara Taila for 14 days along with oral administration of Adityapaka Guggulu tablets twice a day for 30 days |
Matra Basti will be done with Sahachara Taila in the dose of 60 ml once a day for 14 days along with oral administration of Adityapaka Guggulu tablets twice a day for 30 days in 15 patients |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
(1)Patients with the clinical features of Janu-Sandhigata Vata (Osteoarthritis of knee joint).
(2)Patients fit for Basti and Svedana.
(3)Patients with radiological findings of Osteoarthritis along with clinical features
|
|
| ExclusionCriteria |
| Details |
(1)Patients having developed deformity.
(2)Patients with severe form of systemic disorders.
(3)Pregnant women and lactating mother.
(4)Associated with simple or compound fractures.
(5)Patients unfit for Basti and Svedana.
(6)Patients under gone knee replacement surgery.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in WOMAC osteoarthritis Index |
30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1)Radiological improvement in osteoarthritis
(2)Improvement in clinical symptoms of osteoarthritis |
three months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/09/2016 |
| Date of Study Completion (India) |
10/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The trial is a open label randomized clinical trial. The primary aim of the trial is to compare the efficacy of Janu basti (in this therapy medicated oil is sustained externally on specific area of knee joint in certain amount for certain period) with the efficacy of Matra basti ( a form of oily enema) in the management of Janusandhigatavata w.s.r. to osteoarthritis of knee joint. Total 30 patient will be taken for trial. The patient will be randomly divided into two groups of 15 patients each. In group A Janu basti with Sahachar taila will be done for 14 days and oral medication of Adityapaka guggulu will be given for 30 days in the dose of 500 mg twice in a day.In group B Matra basti will be done with Sahachar taila in the dose of 60 ml for 14 days and oral medication of Adityapaka guggulu will be given for 30 days in the dose of 500mg twice in a day. The primary outcome will be the improvement in WOMAC osteoarthritis index.The patient will be assessed after one month and three month of treatment. |