A Clinical Study on Topical Pain formulation in arthritis

Efficacy of a Topical Pain formulation in participants suffering from Osteoarthritis of Knee(s) - A randomized, double blind, placebo controlled, multi-centric, comparative, prospective study - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076439

Enrollment

300

Registered

2024-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed cases of knee pain due to Osteoarthritis 2. Knee joint(s) pain between 30 to 70 on Visual Analogue Scale (VAS) (both inclusive) (mild to moderate pain)

Exclusion criteria

Exclusion criteria: 1. Known chronic severe (more than four years) cases of OA and having developed any kind of joint deformity. 2. Known cases of rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis other than OA, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease 3. Participants with history of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit 4. Participants requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study 5. Participants using systemic corticosteroids within 1 month of screening, 6. Intra articular visco supplementation within the past 3 months 7. Participants with any other investigational drug within 1 month prior to randomization; 8. Participants with uncontrolled diabetes mellitus and hypertension 9. Participants with known tuberculosis, HIV, ischemic heart disease, cancer, kidney failure 10. Pregnant and lactating women 11. Known hypersensitivity to any of the ingredients of Study drugs or to NSAIDs 12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his her participation in, and completion of the protocol

Design outcomes

Secondary

Measure	Time frame
1. Change in pain, stiffness and physical function using graded scale 2. Change in knee joint tenderness and warmness on graded scale 3. Time of onset of action (as pain reliever) after application in min/hrs. 4. Duration of action (as pain reliever) after application in min/hours 5. Global Assessment for overall change in OA by subject and investigator Timepoint: Baseline visit, visit 1 (Day 14) and Visit 2 (Day 28)	—

Measure

Time frame

1. Change in pain, stiffness and physical function using graded scale 2. Change in knee joint tenderness and warmness on graded scale 3. Time of onset of action (as pain reliever) after application in min/hrs. 4. Duration of action (as pain reliever) after application in min/hours 5. Global Assessment for overall change in OA by subject and investigator Timepoint: Baseline visit, visit 1 (Day 14) and Visit 2 (Day 28)

—

Primary

Measure	Time frame
1. Change in knee joint pain on Visual Analogue Scale 2. Change in joint swelling (inflammation) using knee joint girth measurements Timepoint: Baseline visit, visit 1 (Day 14) and Visit 2 (Day 28)	—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Haleon India

atul.x.sharma@haleon.com9820801694

Outcome results