A study to evaluate the Safety and Effectiveness of Fixed Dose Combination of Trypsin 96 mg plus Bromelain 180 mg plus Rutoside Trihydrate 200 mg versus Trypsin - chymotrypsin (1,00,000 AU) in patients with surgical wounds after minor surgery

Phase 4

Recruiting

• Conditions: Patients with surgical wounds after minor surgery

• Registration Number: CTRI/2017/10/010004
• Lead Sponsor: Macleods Pharmaceuticals Ltd

Brief Summary

This Multicentric,Open label, Randomized, Comparative, Clinical Study will evaluate Safety andEfficacy of Fixed Dose Combination of Trypsin 96 mg + Bromelain 180 mg +Rutoside Trihydrate 200 mg enteric coated tablet versus Chymoral Forte (Trypsin - chymotrypsin (1,00,000 AU)) entericcoated tablet in patients for healing potential in surgical wounds afterminor surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-16
• Last Update Posted: 2019-08-01

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 383

Inclusion Criteria

• 1.Male or female patients who are 18 to 65 years of age with surgical wounds after minor surgery.
• 2.Patients able to follow all study directions and commit to come at all follow-up visits as per the protocol.
• In addition, subjects must be willing to accept the restrictions of the study.
• 3.Subjects have the willingness and ability to understand and provide written informed consent to participate in the study.

Exclusion Criteria

• 1.Patients with Uncontrolled diabetes mellitus or any other metabolic disorder.
• 2.Patients with known hypersensitivity to any of the study related drugs.
• 3.Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis.
• 4.Patients taking medicines such as tetracycline group of drugs, amoxicillin, aspirin, anticoagulants including clopidogrel should be excluded.
• 5.Patients who are currently enrolled in another clinical investigation or have been enrolled in any surgical wound trial within a period of 30 days prior to enrollment in this study.
• 6.Women of child bearing age not using any contraceptive.
• 7.Pregnant or nursing women.
• 8.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To evaluate safety and tolerability in patients with surgical wounds after minor surgery. Incidence of adverse events and serious adverse events.	For 1: Day 5, 10. | For 2: Baseline, Day 10.
Safety will be evaluated based on the adverse events reported and their plausible causal relationship with the study drug.	For 1: Day 5, 10. | For 2: Baseline, Day 10.
2. Laboratory Investigations:	For 1: Day 5, 10. | For 2: Baseline, Day 10.
Hematology; Biochemistry.	For 1: Day 5, 10. | For 2: Baseline, Day 10.

Secondary Outcome Measures

Name	Time	Method
Number/percentage of patients with complete wound regeneration on day 5 and 10
BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) score	Baseline, day 5, 10
Patient and investigator global efficacy impression	Day 10

Trial Locations

Locations (13)

Anu Hospital; 🇮🇳 Krishna, ANDHRA PRADESH, India

BhaktiVedanta Hospital & Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

Christian Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Inamdar multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Ishwar Institute of Healthcare; 🇮🇳 Aurangabad, MAHARASHTRA, India

KIMS; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

KRM Hospital and Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

L.T.M.M.C. & L.T.M.G.H, Sion, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Lifepoint Multispeciality Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Mavens Hospital; 🇮🇳 Ajmer, RAJASTHAN, India

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Anu Hospital

🇮🇳Krishna, ANDHRA PRADESH, India

Dr G Ramesh

Principal investigator

08662434855

anuhospitalscr@gmail.com