A study to evaluate safety and efficacy of tablet containing fixed dose of Diclofenac Potassium 50mg and Paracetamol 325 mg andTrypsin Chymotrypsin 50000 AU in management of acute muscle pai

Phase 4

Completed

• Conditions: Health Condition 1: M192- Secondary osteoarthritis of otherjoints

• Registration Number: CTRI/2021/03/032436
• Lead Sponsor: Aglowmed Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-05-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1)Male or female patients between 20-65 years of age,

2)Willing to give written informed consent and willing to comply with trial protocol.

3)Out patients with diagnosis of acute musculoskeletal pain.

4) Patients with at least 6 mm baseline pain rating on VAS scale.

5)Patients not on any anti-inflammatory or other therapy in the past 2 weeks known to affect the study outcome.

6)Ready to comply with protocol.

7)Patients with normal renal and hepatic function as assessed by laboratory examination

Exclusion Criteria

1) Pregnant and lactating women

2) Patients with H/O any drug allergy

3) Unwilling to comply with the protocol requirements

4) Patients with gastro-intestinal disease, peptic ulcer, bleeding disorder and fecal blood loss.

5) Patients with cardiac, hepatic, renal dysfunction and haemopoetic disorder

6) Patients with hypertension

7) Patients deemed ineligible by the investigator

8) H/O skin lesions, skin ulcers

Study & Design

• Study Type: PMS
• Study Design: Not specified