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To determine the efficacy and safety of a topical formulations of diclofenac (2.32% w/v solution)with Methyl Salicylate 10% w/v and Menthol 5% w/v versus a topical Diclofenac Gel (1.16% w/w) with Methyl Salicylate 10% w/w and Menthol 5% w/w in acute low back ache and sprains.

A randomized, two arm, open label, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical formulations of diclofenac (2.32% w/v solution) with Methyl Salicylate 10% w/v and Menthol 5% w/v versus a topical Diclofenac Gel (1.16% w/w) with Methyl Salicylate 10% w/w and Menthol 5% w/w in acute low back ache and sprains.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/091/000001
Enrollment
140
Registered
2011-01-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Acute low back ache and sprains.

Interventions

Intervention1: Diclofenac Topical solution (Diclofenac diethylamine 2.32% w/v) + Methyl Salicylate 10% w/v + Menthol 5% w/v: 4 times a day. Control Intervention1: Diclofenac gel (Diclofenac diethylami

Sponsors

Troikaa Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Male or females patients aged 18- 70 years. 2.Patients with acute low back ache or pain following sprains or sports injuries of duration not more than 2 days 3.Patients with at least moderate pain of VAS ≥ 4

Exclusion criteria

Exclusion criteria: 1.Patients below 18 years or above 70 years of age. 2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation 3.Any contraindication to diclofenac / NSAIDs 4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application 5.Concomitant skin disease at site of application 6.Use of another topical product at application site 7.Pregnant women and lactating mothers 8.Women of child bearing age not practicing or not willing to use contraceptive 9.Unwilling patients. 10.Patients already on oral NSAIDs/ analgesics. 11.Patients requiring hospitalization or other treatment for pain.

Design outcomes

Secondary

MeasureTime frame
Degree of functional impairmentTimepoint: At Visit 1(Baseline) and Visit 2(Day 7, End of Study Visit);Degree of local signs (Swelling, Tenderness)Timepoint: At Visit 1(Baseline) and Visit 2(Day 7, End of Study Visit);Need for rescue analgesia (Paracetamol 500 mg 4 times daily or as advised by the Principal investigator)Timepoint: At Day 3 (Telephonic follow up) and Visit 2 (Day 7, End of Study Visit);Pain intensity at passive movement.Timepoint: At Visit 1(Baseline) and Visit 2(Day 7, End of Study Visit);Pain intensity at restTimepoint: At Visit 1(Baseline), Day 3(Telephonic follow up) and Visit 2(Day 7, End of Study Visit);Patients & Physicians global assessment.Timepoint: At Visit 2(Day 7, End of Study Visit)—

Primary

MeasureTime frame
50% pain reduction at 7 daysTimepoint: Visit 2(Day 7, End of Study Visit);50% pain reduction at 7 daysTimepoint: Visit 2(Day 7, End of Study Visit);50% pain reduction at 7 daysTimepoint: Visit 2(Day 7, End of Study Visit)—

Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

VP - Medical Services Department

Vijayajaiswal@troikaapharma.com0792685624245

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026