A clinical study of Trypsin, Bromelain and Rutoside combination in wound management.

An open label, prospective, multicentric, randomized, controlled, comparative clinical trial to evaluate the safety and efficacy of fixed dose combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg tablets in comparison to Trypsin: Chymotrypsin tablets with 1,00,000 armour units of enzymatic activity in wound management.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/035082

Enrollment

200

Registered

2021-07-23

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 and Rutoside 100 mg tablet: 2 tablets orally 3 times/day for 7 days Control Intervention1: Trypsin: Chymotrypsin tablets with 1,00,000 armour units

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 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) scoreTimepoint: Day 0 to Day 7;Mean change in the total score of surgical wound symptomsTimepoint: 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