Health Condition 1: M190- Primary osteoarthritis of other joints
Conditions
Interventions
Intervention1: AVI- TR 01 ointment: Apply sufficient amount to the affected area and massage gently. Do not rub. For topical use only.
Control Intervention1: Nil: Nil
Sponsors
MN Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in pain score with VAS Changes in WOMAC score Changes in severity of other symptoms like swelling, tenderness Timepoint: Baseline, Day 7 and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Baseline, Day 7 and Day 14 | — |
Countries
India
Contacts
Public ContactMr Ashish Nagaonkar
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed