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.
- Conditions
- Health Condition 1: null- Acute low back ache and sprains.
- Registration Number
- CTRI/2011/091/000001
- Lead Sponsor
- Troikaa Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method