| CTRI Number |
CTRI/2018/10/015907 [Registered on: 05/10/2018] Trial Registered Prospectively |
| Last Modified On: |
03/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of oral intake of Prasarani Taila and rectal administration of Prasarani Taila in the treatment of osteoarthritis of Knee joints |
|
Scientific Title of Study
|
An open lebel randomized clinical study to evaluate the comparative efficacy of Matra basti with Prasarani taila and Prasarani taila pana in the management of Janusandhigatavata 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 |
Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India
Room no.2 Department of Panchakarma, National institute of Ayurveda Jaipur, India
Jaipur
RAJASTHAN
302004
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 |
Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India
Room no.2, Department of Panchakarma National institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8739860237 |
| Fax |
|
| Email |
sarveshksingh21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
M.D. Scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
Room no.2,Department of Panchakarma, National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India
Room no.2,P.G.Department of Panchakarma National institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9887908459 |
| Fax |
|
| Email |
drashokrau05@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Ayurveda, Jorawar Singh Gate,Jaipur ,INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Madhav Vilas Hospital,Jorawar Singh Gate,Jaipur,Rajasthan,India |
| 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 Jaipur |
Room no.2,Department of Panchakarma,National institute of Ayurveda,Jorawar Singh Gate, Jaipur,India
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
8739860237
sarveshksingh21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics commitee, National Institute of Ayurveda Jaipur |
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 |
Anal administration of Matra Basti in the dose of 60 ml once a day with Prasarni Taila for 14 days |
Matra Basti(anal administration of oil) will be done with Prasarani Taila in the dose of 60 ml once a day for 14 days |
| Comparator Agent |
oral administration of Prasarini Taila in the dose of 20 ml twice a day in morning and evening for 14 days |
Taial pana (oral administration) of Prasarini Taila in the dose of 20 ml twice a day in morning and evening with empty stomach and with lukewarm water for 14 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 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 Matra Basti and Taila Pana.
(3)having symptoms of OA (above 3 months and maximum 10 years confirmed
by radiological changes as per grade I to III of Kellgren & Lawrence
radiological scale and diagnosed as per American college of
Rheumatology diagnostic criteria for OA of the knee) and willing
able to participate in the study for 04 weeks |
|
| 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 under gone knee replacement surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in WOMAC total score |
One month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the changes in the score of three sub scales i.e.
WOMAC Pain subscale, WOMAC Stiffness subscale, WOMAC physical
function subscale and Global assessment of disease activity |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/01/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
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 Matra basti( ( a form of oily enema) with Prasarini Taila(oil) and efficacy of oral intake of Prasarini taila ( oily) in the management of Janusandhigatavata w.s.r. to osteoarthritis of knee joint. Total 60 patient will be taken for trial. The patient will be randomly divided into two groups of 30 patients each. In group A Matra basti with Prasarini taila will be done for 14 days .In group B oral intake( Taila Pana) of Prasarini taila in the dose of 20ml twice a day for 14 days . The primary outcome will be the improvement in total score of WOMAC osteoarthritis index.The patient will be finally assessed after one month of treatment. |