A study of Trypsin, Bromelain, Rutoside and Diclofenac combination in comparison with Diclofenac to observe rapid healing of the wound and reducing pain intensity in surgery patients.

An open label, multicentric, randomized, comparative clinical trial to evaluate safety and efficacy of fixed-dose combination of Trypsin 48 mg, Bromelain 90 mg, Rutoside 100 mg and Diclofenac 50 mg tablet in comparison to Diclofenac 50 mg tablet in wound management.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032053

Enrollment

200

Registered

2021-03-17

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: L089- Local infection of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: FDC of Trypsin 48 mg, Bromelain 90 mg, Rutoside 100 mg and Diclofenac 50 mg tablet: 1 tablet orally 3 times/day for 7 days. Control Intervention1: Diclofenac: Diclofenac 50 mg Control I

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years. 2. Patients with elective clean and uncontaminated surgery. 3. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to any of the study drugs. 2. Patients with severe renal impairment. 3. Patients with severe hepatic impairment. 4. Patients with hereditary coagulation disorder. 5. Women who are pregnant or lactating. 6. Patients with any other condition that, in the opinion of the investigator, does not justify his/her inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Percentage of patients reporting incidences of adverse events.Timepoint: Day 0 to Day 7	—

Secondary

Measure	Time frame
Mean change in Numerical Pain Rating Scale (NPRS).Timepoint: Day 0 to Day 7;Mean change in the total score of surgical wound symptoms.Timepoint: Day 0 to Day 7	—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Limited

Bhupesh.Dewan@zuventus.com022-30610000

Outcome results

None listed

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