| CTRI Number |
CTRI/2019/02/017696 [Registered on: 18/02/2019] Trial Registered Prospectively |
| Last Modified On: |
17/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study on the combined effectiveness of maharasnadi kashaya with shunti churna and matra basti with ksheerabala taila in the management of osteoarthritis of knee |
|
Scientific Title of Study
|
Clinical study on the combined effectiveness of maharasnadi kashaya with shunti churna and matra basti with ksheerabala taila in the management of janu sandhigata vata( osteoarthritis of knee) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Kiran |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda |
| Address |
Sri Dharmasthala Manjunatheshwara college of ayurveda Hassan
Thanneeruhalla
Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
8277409245 |
| Fax |
|
| Email |
kkiran0909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasantha B |
| Designation |
Assistant professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda |
| Address |
Sri Dharmasthala Manjunatheshwara college of ayurveda Hassan
Thanneeruhalla
Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886213224 |
| Fax |
|
| Email |
drvasantha@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
K Kiran |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda |
| Address |
Sri Dharmasthala Manjunatheshwara college of ayurveda Hassan
Thanneeruhalla
Hassan
573201
Hassan
KARNATAKA
573201
India |
| Phone |
8277409245 |
| Fax |
|
| Email |
kkiran0909@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr K Kiran |
| Address |
Sri Dharmasthala Manjunatheshwara college of ayurveda Hassan |
| Type of Sponsor |
Private 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 K Kiran |
Sri Dharmasthala Manjunatheshwara college of ayurveda hassan |
In patient department of kayachikitsa division
Hassan
KARNATAKA |
8277409245
kkiran0909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheshwara college of ayurveda Hassan |
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 |
| Intervention |
Maharasnadi kashaya
Shunti churna
Ksheerabala taila |
Maharasandi kashaya in the dose of 15 ml tid afterfood along with shunti churna 4g tid afterfood orally
Ksheerabala taila 70ml daily afterfood for matra basti procedure ie through rectal route
|
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
O.A of bilateral knees
Patients willing to participate and sign the informed consent form |
|
| ExclusionCriteria |
| Details |
Congenital bone deformity
Known case of tuberculosis, HIV, HbSAg, carcinoma
Uncontrolled DM and HTN |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.The signs and symptoms of Janu Sandhi Gata Vata assessed at day1,day8 and day 24 2.ACR Revised criteria (2016) for early diagnosis of knee O.A assessed on day1,8 and day24 3.Ritchie articular index for assessment of tenderness assessed at day1,8 and day24 |
1.The signs and symptoms of Janu Sandhi Gata Vata on day 1,8,24 2.ACR Revised criteria (2016) for early diagnosis of knee O.A on day1,8,24 3.Ritchie articular index for assessment of tenderness on day1,8,24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
WOMAC osteoarthritis index (modified)
Range of movements - measured by goniometer.
Body mass index |
WOMAC osteoarthritis index (modified) measured on day1,day8 and day24 of study
Range of movements - measured by goniometer on day1,day8, day24 of study.
Body mass index- on day1,day8 and day24 |
|
|
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 4 |
|
Date of First Enrollment (India)
|
18/02/2019 |
| 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="0"
Days="24" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis of knee has a prevalance of 22-39% in Indian. Prravalance increases dramatically with age . The major risk factors associated with osteoarthritis of knee are oldage, obesity, excessive usage of knee which makes it an important cause of disabilty. O.A od knee remebles lakshanas of janusandhi gata vata. Interventions like maharasnadi kashaya with shunti churna and matra basti with ksheerabala taila in a prescribed dosage as per classics is told beneficial in vata vyadhi as per ayurvedic classics. Considering the prevalance of O.A of knee and the classical reference of interventons, the study has been taken as a research topic |