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

A Prospective, Multicentric, Non-comparative Phase IV Clinical Trial Evaluating Safety and Efficacy of Fixed Dose Combination (FDC) of DICLOFENAC POTASSIUM BP + PARACETAMOL IP +TRYPSIN AND CHYMOTRYPSIN (50MG-+325MG+50,000 ARMOUR) FILM COATED TABLETS in the management of acute musculoskeletal pain

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2021/03/032436

Enrollment

200

Registered

2021-03-30

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: M192- Secondary osteoarthritis of otherjoints

Interventions

Intervention1: Not applicable: Not applicable Intervention2: DICLOFENAC POTASSIUM BP 50MG AND PARACETAMOL IP 325MG AND TRYPSIN AND CHYMOTRYPSIN 50000 ARMOUR FILM COATED TABLETS: Dose- One tablet BID f

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary objective of the given Phase-IV trial is to prove evidence of safety. The time-point for assessment of safety and efficacy is 3-5 days after dosing and at the end of trial at Day 10 or early as per investigatorÃ¢â?¬â?¢s discretion based on patient response to treatment. Timepoint: The patients will be evaluated for safety and efficacy at the time of inclusion in the study, intermittently on Day 3-5 and at the end of study on Day 10 or before as per investigator discretion. Safety of patients will be evaluated by vital signs (temperature, blood pressure, Pulse rate and respiratory rate) and monitoring well-being / adverse events during entire study period.	—

Measure

Time frame

The primary objective of the given Phase-IV trial is to prove evidence of safety. The time-point for assessment of safety and efficacy is 3-5 days after dosing and at the end of trial at Day 10 or early as per investigatorÃ¢â?¬â?¢s discretion based on patient response to treatment. Timepoint: The patients will be evaluated for safety and efficacy at the time of inclusion in the study, intermittently on Day 3-5 and at the end of study on Day 10 or before as per investigator discretion. Safety of patients will be evaluated by vital signs (temperature, blood pressure, Pulse rate and respiratory rate) and monitoring well-being / adverse events during entire study period.

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Secondary

Measure	Time frame
Efficacy Parameter: The inflammatory marker levels (C-Reactive Protein) shall be measured at baseline and at the end of study. % improvement in physical measurement of inflammation and inflammatory markers shall be analysed. The Clinical Global Impression of change (CGIC) will be assessed at the completion treatment. Timepoint: % improvement in VAS score of pain during intermittent visit on Day 3-5 and at the completion of study on Day-10 or before shall be analysed. Tenderness shall also be assessed at baseline and during each visit. Swelling score shall be assessed based on physical measurement on Day 0, Day 3-5 and Day 10 or before as per Investigator discretion.	—

Measure

Time frame

Efficacy Parameter: The inflammatory marker levels (C-Reactive Protein) shall be measured at baseline and at the end of study. % improvement in physical measurement of inflammation and inflammatory markers shall be analysed. The Clinical Global Impression of change (CGIC) will be assessed at the completion treatment. Timepoint: % improvement in VAS score of pain during intermittent visit on Day 3-5 and at the completion of study on Day-10 or before shall be analysed. Tenderness shall also be assessed at baseline and during each visit. Swelling score shall be assessed based on physical measurement on Day 0, Day 3-5 and Day 10 or before as per Investigator discretion.

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Countries

India

Contacts

Public ContactKapil Pandya

Inquest Biopharm Pvt Ltd

kapil@inquestbp.com917949000004

Outcome results

None listed

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