In patients presented with mechanical low back pain in emergency department.

A multicentric, randomized, parallel group, open-label, comparative phase 3 clinical trial to evaluate the efficacy, safety and to analyze analgesic effect of Ketoprofen 2.5 % w/w + Alcohol 36.8 % v/w gel (manufactured by Akums Drugs & Pharmaceuticals Limited.) versus Ketoprofen Gel (manufactured by Minareni) in patients with musculoskeletal pain.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052328

Enrollment

178

Registered

2023-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure

Interventions

Intervention1: Ketoprofen Gel manufactured by Akums Drugs & Pharmaceuticals Limited: Ketoprofen IP 2.5% w/w Alcohol IP 36.8% v/w 1 time local application at pain site Total duration 7 DAYS Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients (male and female) presenting with mechanical low back pain in emergency department with VAS score >= 40mm on Visual Analogue Scale. 2. Patients who are able to and willing to provide written informed consent. 3. Patients who are cooperative and with understanding skills. 4. Patients willing and assessed to be able to participate in all aspects of the core study, including investigational product application, completion of evaluations, and compliance with protocol requirements.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity/ history of allergy to any of the Investigational productâ??s components. 2. Patient, unwilling to participate in the clinical trial study. 3. Patients having pain more than 24 hours. 4. Patients having pain lower than with a pain score of 40 mm on visual analogue scale. 5. Patients having allergy to ketoprofen. 6. Recent use of psycho-active medication, drug or alcohol addiction. 7. Female, pregnant or breast feeding patient.

Design outcomes

Primary

Measure	Time frame
To determine the change in the VAS (Visual Analogue Scale) scoreTimepoint: from baseline to 15 minutes and 30 minutes after local application of the investigational product at pain site.	—

Secondary

Measure	Time frame
Number of participants reporting adverse events (AEs).Timepoint: from baseline to end of the study;Number of participants reporting local reactions such as skin rash, itching etc. Timepoint: from baseline to 15 minutes and 30 minutes	—

Countries

India

Contacts

Public ContactDr S Sadgune

Mudra Clincare

dr.sayalitarte@gmail.com8291745386

Outcome results

None listed

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