CTRI Number |
CTRI/2019/05/019131 [Registered on: 15/05/2019] Trial Registered Prospectively |
Last Modified On: |
14/05/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Role OF LAGHU VISHAGARBHA TAILA
AND MARMA THERAPY IN THE MANAGEMENT OF SANDHIGATA VATA w.s.r. TO OSTEOARTHRITIS
|
Scientific Title of Study
|
A Comparative Clinical Study Of Local Application OF LAGHU VISHAGARBHA TAILA
AND MARMA THERAPY IN THE MANAGEMENT OF SANDHIGATA VATA w.s.r. TO OSTEOARTHRITISâ€
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrSunil Kumar Joshi |
Designation |
Professor |
Affiliation |
Rishikul campus |
Address |
Shalya tanra department Rishikul campus ,u.a.u ,Haridwar
Hardwar UTTARANCHAL 249401 India |
Phone |
9897523499 |
Fax |
|
Email |
mrityunjaymission@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Urvashi |
Designation |
P.g scholar |
Affiliation |
Rishikul campus |
Address |
Department of shalya tantra Rishikul campus, u.a.u,haridwar
Hardwar UTTARANCHAL 249401 India |
Phone |
9761055936 |
Fax |
|
Email |
urvashipanwar2009@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Urvashi |
Designation |
P.g scholar |
Affiliation |
Rishikul campus |
Address |
Department of Shalya tantra Rishikul campus, u.a.u,haridwar
Hardwar UTTARANCHAL 249401 India |
Phone |
9761055936 |
Fax |
|
Email |
urvashipanwar2009@gmail.com |
|
Source of Monetary or Material Support
|
Department of Shalya tantra Rishikul ayurvedic hospital |
|
Primary Sponsor
|
Name |
Uttrakhand Ayurved University |
Address |
Uttrakhand Ayurved Uiversity,Railway road ,Harrawala, Dehradun |
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 |
Urvashi |
Rishikul Ayurvedic Hospital |
Department of Shalya tantra Rishikul campus, U.A.U,Haridwar Hardwar UTTARANCHAL |
9761055936
urvashipanwar2009@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Uttrakhnd ayurved university |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group A |
15 patients of this group will be treated with laghu vishagarbha taila
•Mode of administration – local gentle application on the affected joint.
|
Comparator Agent |
Group B |
15 patients will be given marma therapy.
•Mode of administration – local , Thrice a day 15-18 times per sitting
|
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Inclusion Criteria
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Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
INCLUSION CRITERIA-
1.Patients fulfilling the diagnostic criteria of Sandhigata Vata (OA)
2.Patients aged between 30 -70 years will be included of either sex.
|
|
ExclusionCriteria |
Details |
EXCLUSION CRITERIA-
1.Patients having history of joint trauma, secondary and other systemic illness.
2.Patients suffering from any systemic diseases like tuberculosis, rheumatoid arthritis, gouty arthritis, psoriatic arthritis .
3.Patient suffering from infectious osteoarthritis.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Complete remission:100% relief
Markedly improved:76-99% relief
Moderately improved:51%-75% relief
Improved:26%-50% relief
Unchanged:0% – 25% relief
|
Complete remission:100% relief
Markedly improved:76-99% relief
Moderately improved:51%-75% relief
Improved:26%-50% relief
Unchanged:0% – 25% relief
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Exacerbation in sign and symptom |
90 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
|
N/A |
Date of First Enrollment (India)
|
20/05/2019 |
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="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Sandigata Vata
is a common condition which can be correlated with osteoarthritis. Sandhigata
vata is a common type of Vatic disorder
afflicting the society. Owning to distracting nature and difficult anagement ata
vyadhi has been included in Asht mahagad. Osteoarthritis is a joint failure, a
disease in which all structures of the joint have under gone pathology change.
This is accompanied by increasing thickness and sclerosis of the subchondral
bony plate, by outgrowth of osteophytes at the joint margin, by stretching of
the articular capsule, by mild synovitis in many affected joints, and by the
weakness of muscles bridging the joint. OA is a long term chronic disease
characterized by the deterioration of cartilage in joints which result in bones
rubbing together and creating stiffness, pain and impaired movement. The
disease most commonly affects the joints in the knees, hands, feet, and spine
and is related to ageing. It is also associated with a variety of both modifiable
and non-modifiable risk factors, including obesity lack of exercise, genetic
predisposition, bone density, occupational injury, trauma and gender.
|