A Study to evaluate the Safety and Efficacy of FDC of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg plus Diclofenac Sodium 50 mg enteric coated tablet versus Diclofenac Sodium 50 mg enteric coated tablet in patients with surgical wounds after minor surgery.

Phase 4

Recruiting

• Conditions: Patients with surgical wounds after minor surgery

• Registration Number: CTRI/2017/11/010384
• Lead Sponsor: Macleods Pharmaceuticals Ltd

Brief Summary

This Multicentric, Open label, Randomized, Comparative, Clinical Study will evaluate Safety and Efficacy of Fixed Dose Combination of Trypsin 48 mg + Bromelain 90 mg + Rutoside Trihydrate 100 mg + Diclofenac Sodium 50 mg enteric coated tablet Versus Diclofenac Sodium 50 mg enteric coated tablet in patients for healing potential in surgical wounds after minor surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female patients who are 18 to 65 years of age with surgical wounds after minor surgery.
• 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.
• Subjects have the willingness and ability to understand and provide written informed consent to participate in the study.

Exclusion Criteria

• Patients with Uncontrolled diabetes mellitus or any other metabolic disorder.
• Patients with known hypersensitivity to any of the study related drugs.
• Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis.
• 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.
• 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
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.
Hematology; Biochemistry.	For 1: Day 5, 10. | For 2: Baseline, Day 10.
Incidence of adverse events and serious adverse events.	For 1: Day 5, 10. | For 2: Baseline, Day 10.
1. To evaluate safety and tolerability in patients	For 1: Day 5, 10. | For 2: Baseline, Day 10.
with surgical wounds after minor surgery.	For 1: Day 5, 10. | For 2: Baseline, Day 10.
2. Laboratory Investigations:	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.	Baseline,Day 5 and Day 10.
BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) score	Baseline,Day 5 and Day 10.
Patient and investigator global efficacy impression	Day 10

Trial Locations

Locations (9)

Anu Hospital; 🇮🇳 Krishna, ANDHRA PRADESH, India

Bhatia Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. D. Y. Patil Medical College, hospital & Research Center; 🇮🇳 Pune, MAHARASHTRA, India

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

Popular Hospital; 🇮🇳 Varanasi, UTTAR PRADESH, India

Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital; 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Sir Sayajirao General Hospital; 🇮🇳 Vadodara, GUJARAT, India

Sudbhawana Hosptial; 🇮🇳 Varanasi, UTTAR PRADESH, India

Vinaya Hospital And Research Centre; 🇮🇳 Kannada, KARNATAKA, India

Anu Hospital

🇮🇳Krishna, ANDHRA PRADESH, India

Dr K Durga Nagaraju

Principal investigator

9885127788

drnagarajuk@gmail.com