| CTRI Number |
CTRI/2020/08/027462 [Registered on: 28/08/2020] Trial Registered Prospectively |
| Last Modified On: |
18/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management of Sandhivata |
|
Scientific Title of Study
|
A STUDY OF ‘JANU’ AND ‘SAKTHIGATA ANI MARMA’ W.S.R TO SANDHIVATA AND THERAPEUTIC EFFECT OF SVEDENA AND VIMLAPANA KARMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manish Choudhary |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Rachana Sharir DSRRAU Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9571475995 |
| Fax |
|
| Email |
shivamanishchoudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mahendra Sharma |
| Designation |
Professor & HOD |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Rachana Sharir DSRRAU, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166191561 |
| Fax |
|
| Email |
vdmahendrasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mahendrs Sharma |
| Designation |
Professor & HOD |
| Affiliation |
DSRRAU, Jodhpur |
| Address |
P.G. Department of Rachana Sharira DSRRAU Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166191561 |
| Fax |
|
| Email |
vdmahendrasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Nagaur Road Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur PIN-342037 |
| 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 Mahendra Sharma |
Dr. Sarvepalli Radhakrishnan rajasthan Ayurved University, University Hospital of Ayurved |
OPD No. 13 Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwar Nagaur Road Jodhpur Pin- 342037
Jodhpur
RAJASTHAN |
9166191561
vdmahendrasharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
svedana & Vimplapana Karma |
Patra pinda svedana and vimlapana with maha visha garbha taila on janu and ani marma for 7 days after every 15th day follow up for 45 days. |
| Intervention |
svedena and vimlapana karma with general prescribed medicines |
Patra pinda Svedana and vimlapana karma with maha vishagarbha taila on janu and ani marma in linear and circular motion along with general prescribed medicine. svedana and vimlapana will be done for 7 days after every 15 days follow up for 45 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients having classical features of sandhishoola,sandhishotha,sthabdhata and sparshaasahyta. |
|
| ExclusionCriteria |
| Details |
patients having severe disease like cardiac disease,pulmonary tuberculosis,diabetes,renal function impairment,raised value of serum uric acid than normal value,extreme reduce in joints,chronicity of sandhigatavatavata more than 5years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in subjective and objective critria |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to find efficacy of vimlapana and svedena karma with mahavisgarbh tail in sandhivata |
45 days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
07/09/2020 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IT IS A RANDOMIZED PARALLEL GROUP CLINICAL TRIAL OF 30 PATIENTS WHICH ARE DIVIDED IN 2 GROUPS CONSISTS OF 15 PATIENTS.FIRST GROUP WILL BE TREATED WITH MEDICINE PRESCRIBED IN O.P.D/I.P.D AND SVEDENA AND VIMLAPANA KARMA ON JANU AND SAKTHIGATA ANI MARMA WHILE SECOND GROUP WILL BE TREATED WITH ONLY SVEDENA AND VIMLAPNA KARMA.
|