| CTRI Number |
CTRI/2017/08/009216 [Registered on: 01/08/2017] Trial Registered Prospectively |
| Last Modified On: |
29/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on local application of oil on knee joint (Janu pichu) and anal administration of drugs (basti) along with oral medicine in the management of osteoarthritis Of knee joints |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Ksheer bala taila in Matra basti and Janu pichu along with Aswagandha shatavari ksheer pak in the management of Janu sandhigata vata w.s.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 |
| 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 |
| Address |
P.G. Department of Panchakarma, National Institute of Ayurveda,Jorawar singh Gate,Jaipur
RAJASTHAN
302002
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Champak Kumar Pathak |
| Designation |
M.D. 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 |
9435759284 |
| Fax |
|
| Email |
drchampakkrpathak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jorawar Singh Gate,Jaipur,Rajasthan |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
National Institute of Ayurveda,Jorawar singh Gate,Jaipur |
| 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 Sarvesh Kumar Singh |
National institute of Ayurveda |
Room no.2,P.G.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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Janu Pichu with Ksheerbala Taila for 10 days along with oral administration of Aswagandha Shatavari Ksheer pak(drugs processed in milk) in the dose of 10 g twice a day for 30 days |
Janu pichu will be done with Ksheerbala Taila once a day for 10 days along with oral administration of Aswagandha Shatavari Ksheer pak in the dose of 10 g twice a day for 30 days in 15 patients |
| Intervention |
Matra Basti with Ksheerbala Taila for 10 days along with oral administration of Aswagandha Shatavari Ksheer pak(drugs processed in milk) in the dose of 10 g twice a day for 30 days |
Matra Basti will be done with Ksheerbala Taila in the dose of 60 ml once a day for 10 days along with oral administration of Aswagandha Shatavari Ksheer pak in the dose of 10 g twice a day for 30 days in 15 patients |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 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. |
|
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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 |
2month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1)Radiological improvement in osteoarthritis
(2)Improvement in clinical symptoms of osteoarthritis |
2 months |
|
|
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 |
|
Date of First Enrollment (India)
|
01/09/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 pichu (in this therapy medicated oil soaked in cotton 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 pichu with ksheerbala taila( oil) will be done for 10 days and oral medication of Ashwagandha Shatavari Ksheer pak will be given for 30 days in the dose of 10g twice in a day.In group B Matra basti will be done with Ksheerbala taila in the dose of 60 ml for 10 days and oral medication of Aswagandha shatavari ksheer pak will be given for 30 days in the dose of 10g twice in a day. The primary outcome will be the improvement in WOMAC osteoarthritis index.The patient will be assessed after two months of treatment. |