| CTRI Number |
CTRI/2021/10/037470 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
16/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study of a AVI- TR 01 ointment in Patients with arthritis of knee and low back ache. |
|
Scientific Title of Study
|
A parallel arm interventional Clinical Study to Assess the Efficacy and Tolerability of a AVI- TR 01 ointment in Patients with chronic osteoarthritis of knee and low back ache. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/21-22/001 Ver.1. dated 6 April 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Umesh Gajare |
| Designation |
Consultant |
| Affiliation |
Jyoti Clinic and Research Centre |
| Address |
OPD 1 Ground floor B 3 Saipritam kaliwadi Rahatni link Road
Kalewadi Pune MAHARASHTRA India
Pune
MAHARASHTRA
411017
India |
| Phone |
8796739140 |
| Fax |
|
| Email |
dr.gajareumesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Managing Director |
| Affiliation |
Mprex Healthcare Pvt. Ltd. |
| Address |
501 Crossroads Wakad Pune MAHARASHTRA India
Pune
MAHARASHTRA
411057
India |
| Phone |
8554912644 |
| Fax |
|
| Email |
gayatri.mbgindia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish Nagaonkar |
| Designation |
Partner |
| Affiliation |
M.N.Pharmaceuticals |
| Address |
27 Madhumansion Old P B Road NIPANI Belgaum
KARNATAKA
India
Belgaum
KARNATAKA
591237
India |
| Phone |
7892647421 |
| Fax |
|
| Email |
pharmaceuticals.m.n@gmail.com |
|
|
Source of Monetary or Material Support
|
| MN Pharmaceuticals, R S NO 51 1B KLE CBSE CORNER BUDALMUKH ROAD NIPANI |
|
|
Primary Sponsor
|
| Name |
MN Pharmaceuticals |
| Address |
R S NO 51 1B KLE CBSE CORNER BUDALMUKH ROAD NIPANI |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Umesh Gajare |
Jyoti clinic and research center |
OPD 1, Ground floor, B3 Sai Pritam, Kalewadi, rahatani link road, Kalewadi
Pune
MAHARASHTRA |
8796739140
dr.gajareumesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Medical Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M190||Primary osteoarthritis of other joints. Ayurveda Condition: Sandhivat, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AVI- TR 01 ointment |
Apply sufficient amount to the affected area and massage gently. Do not rub. For topical use only. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects aged 30 to 65 years
Patients with back pain for at least 3-6 months with score on VAS more than or equal to 4
Patients with Knee pain for at least 3-6 months with score on VAS more than or equal to 4
Suffering from joint discomfort for at least 3 months duration
Subjects agreeing to discontinue any use of analgesics during the study.
Ready to provide written informed consent
Willing to come for the follow-up visits for evaluation
|
|
| ExclusionCriteria |
| Details |
Surgery for low back pain/ knee joint pain in the last 6 months or planning for surgical intervention during the course of the study.
Sensitive skin and damaged/ broken skin at the application site.
Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Paget’s disease, hemophilia etc.
Presence of any severe medical or psychological condition
Patients participated in another clinical drug trial within 3 months before recruitment in this trial
Any other medical condition that in the Investigators opinion would preclude patient participation
Subjects with past history of addiction abuse and rehabilitation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in pain score with VAS
Changes in WOMAC score
Changes in severity of other symptoms like swelling, tenderness
|
Baseline, Day 7 and Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of quality of life (QoL)
Changes in in requirement of analgesics as a rescue medication
Assessment of patient compliance
Assessment of study product tolerability
Adverse events/ Adverse drug reactions
|
Baseline, Day 7 and Day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/10/2021 |
| 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="14" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study is to clinically validate the effectiveness of AVI- TR 01 ointment in subjects suffering from osteoarthritis of knee and low back ache
|