Clinical Study of a AVI- TR 01 ointment in Patients with arthritis of knee and low back ache.
- Conditions
- Health Condition 1: M190- Primary osteoarthritis of other joints
- Registration Number
- CTRI/2021/10/037470
- Lead Sponsor
- MN Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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, Pagetâ??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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in pain score with VAS <br/ ><br>Changes in WOMAC score <br/ ><br>Changes in severity of other symptoms like swelling, tenderness <br/ ><br>Timepoint: Baseline, Day 7 and Day 14
- Secondary Outcome Measures
Name Time Method Assessment of quality of life (QoL) <br/ ><br>Changes in in requirement of analgesics as a rescue medication <br/ ><br>Assessment of patient compliance <br/ ><br>Assessment of study product tolerability <br/ ><br>Adverse events/ Adverse drug reactions <br/ ><br>Timepoint: Baseline, Day 7 and Day 14