| CTRI Number |
CTRI/2019/01/017150 [Registered on: 18/01/2019] Trial Registered Prospectively |
| Last Modified On: |
18/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study the effects of matra basti and shamana sneha with Vishnu taila in Janu sandhigata vata |
|
Scientific Title of Study
|
Management of Janu sandhigat vata (osteoarthritis of knee joint )with matra basti and shamana sneha with Vishnu tail -an open labelled randomized comparative clinical trial . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hiralben pravinbhai gohel |
| Designation |
Pg scholar |
| Affiliation |
Govt akhandanand ayurved college bhadra ahmedabad |
| Address |
room no 11 panchakarma dept Govt akhandanand ayurved college bhadra ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9408848258 |
| Fax |
|
| Email |
gohelhiral10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krupali raut |
| Designation |
Lecturer |
| Affiliation |
Govt akhandanand ayurved college bhadra ahmedabad |
| Address |
room no 11 panchkarma department Govt akhandanand ayurved college bhadra ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9427149250 |
| Fax |
|
| Email |
rautkajal77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hiral gohel |
| Designation |
pg scholar |
| Affiliation |
Govt akhandanand ayurved college bhadra ahmedabad |
| Address |
room no 11 panchkarm department Govt akhandanand ayurved college bhadra ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9408848258 |
| Fax |
|
| Email |
gohelhiral10@gmail.com |
|
|
Source of Monetary or Material Support
|
| room no 11 panchkarm department Govt.akhandanand ayurved college, bhadra , Ahmedabad |
|
|
Primary Sponsor
|
| Name |
Govt akhandanand ayurved college bhadra ahmedabad |
| Address |
Govt akhandanand ayurved college bhadra ahmedabad |
| 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 |
| Hiral gohel |
govt akhandanandayurved college |
room no 11 panchkarma deprtment govt akhandanadayurvedic hospital bhadra ahemdabad
Ahmadabad
GUJARAT |
9265264745
gohelhiral10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
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 |
matra basti and shamana sneha |
Total 15 Basti will be administered to each patient in the course of Matra Basti MATRA BASTI 15 Matra Basti will be administered to each patient Each Basti will be administered as per classical method of Matra Basti Drug Vishnu Tail
Preparation method Vishnu Tail will be made as per described by Chakrdatta Dose 50 -70 ml
Basti pradan kal Immidiately after meal (At noon)
Patients will be treated with Shamana Sneha of Vishnu Tail with 15 days Drugs As per described in group A
Preparation method As per described in group A Dose 20 30 ml Time Shamana Sneha will be taken at Annkale prakanshite at lunch time Duration– 15 days
|
| Comparator Agent |
dashmool kwath |
Drugs Dashmool Kwath Dose 30 ml Time Twice a day at morning and evening(empty stomach)
Duration– 15 days Contents of Dashmool Kwath (Reference- Chakrdatta chi 22/82)
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Matra Basti Yogya Snehpana Yogya Patients having signs & symptoms of Sandhigat Vata (Osteoarthritis of knee joint) with fulfilling Diagnostic criteria
|
|
| ExclusionCriteria |
| Details |
Matra Basti Ayogya Snehpana Ayogya Patients suffering from Vatarakta Amavata Systemic Lupus Erythematous (SLE) Bone TB Psoriatic arthritis and other serious systemic disorders will be excluded
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of sign and symptoms of janusandhigata vata and objective criteria |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of sign and symptoms of janusandhigata vata and objective criteria |
15 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/01/2019 |
| 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="0"
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
|
Management of Janu sandhigat vata ( osteoarthritis of knee joint ) with matra basti and shamana sneha with vishnu tail - an open labelled randomized clinical trial |