| CTRI Number |
CTRI/2019/07/020129 [Registered on: 10/07/2019] Trial Registered Prospectively |
| Last Modified On: |
09/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two therapies, anterior knee joint dipping in oil and whole knee joint dipping in oil with new instrument in patients with Janusandhigata vata(Osteoarthritis of Knee joint) |
|
Scientific Title of Study
|
COMPARITIVE CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF JANU BASTI WITH CONVENTIONAL METHOD AND JANU AVAGAHA WITH MODIFIED INSTRUMENT IN THE MANAGEMENT OF JANUSANDHIGATA VATA |
| Trial Acronym |
RACE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnimesh Mohan |
| Designation |
PG Scholar |
| Affiliation |
Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Departmentof Panchakarma
Sri DharmasthalaManjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
BM Road Thanniruhalla Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9457438200 |
| Fax |
|
| Email |
saxena.animeshmohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnimesh Mohan |
| Designation |
PG Scholar |
| Affiliation |
Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Departmentof Panchakarma
Sri DharmasthalaManjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9457438200 |
| Fax |
|
| Email |
saxena.animeshmohan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Panchakarma
Sri DharmasthalaManjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India
Hassan
KARNATAKA
573201
India |
| Phone |
9448705660 |
| Fax |
|
| Email |
ashvinipanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan 573201 Karnataka
India |
| 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 Animesh Mohan |
Sri Dharmasthala Manjunatheshwara Ayurveda Hospital |
OPD No 14 and IPD, Department of Panchakarma, Sri Dharmasthala Manjunatheshwara Ayurveda Hospital
BM Road Thanniruhalla Hassan 573201
Hassan
KARNATAKA |
7905616470
saxena.animeshmohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri DharmasthalaManjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
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 |
Janu Avagaha using Murchita tila taila |
Janu Avagaha using Murchita tila taila with modified Janu Avagaha instrument for 45 minutes once in a day for 7 consecutive days |
| Comparator Agent |
Janu Basti using Murchitatila taila |
Janu Basti using Murchitatila taila with conventional method,45 minutes once in a day for 7 consecutive days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects diagnosed as per the criteria for Janusandhigata vata (Osteoarthritis of knee joint)
2. Persistent pain for 3 months prior to recruitment
3. Moderate‑to‑severe pain on walking
4. Either gender in age group 40 – 70 years
5. Fully ambulant, literate and willing to participate in the study.
6. Subjects of either gender, irrespective of socio-economic status |
|
| ExclusionCriteria |
| Details |
1. Acute knee pain
2. Secondary OA
3. Major medical or psychiatric disorders.
4. Congenital bone deformity
5. Grade 4 Joint deformity35
6. History of HIV, HbSAg, Carcinoma and Tuberculosis
7. Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Signs and symptoms of Janusandhigata Vata (Osteoarthritis of Knee joint) will be assessed by giving suitable scoring at three intervals namely before, 4th day and 8th day i.e. after completion of treatment.
The disease activity of the patient will be assessed by WOMAC Osteoarthritis Index, Range of movement- Measured using Goniometer |
before, 4th day and 8th day i.e. after completion of treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Swelling, tenderness will be evaluated on the basis of standard criteria of Ritchie Articular Index, Crepitus, Walking velocity, pain during movement |
before, 4th day and 8th day i.e. after completion of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
15/07/2019 |
| 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="2"
Months="0"
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
|
This study is an open label, double
arm, prospective, comparative clinical study to know the effectiveness of A.
Janu
Basti using Murchitatila taila with conventional method, 45 minutes once in a
day for 7 consecutive days in 20 patients B.
Janu
Avagaha using Murchitatila taila with modified Janu Avagaha instrument for 45
minutes once in a day for 7 consecutive days for 20 patients
that will be conducted in India. The primary
outcome measures will be WOMAC
Osteoarthritis Index, Range of movement- Measured using Goniometer, Swelling(Sotha),
tenderness will be evaluated on the basis of standard criteria of Ritchie
Articular Index, Crepitus, Walking velocity, pain during movement (AkuncanaPrasaraneVedana)
at 8 days. |