Phlogam and Disperzyme use for reducing pain and swelling after small surgery

Phase 4

Completed

• Conditions: Complications of surgical and medical care, not elsewhere classified,

• Registration Number: CTRI/2017/12/010804
• Lead Sponsor: Aksigen Hospital Care

Brief Summary

This was a multicentre, randomised, assessor blind, active controlled, phase IV study to assess the safety and efficacy of two treatment groups - Phlogam and Dispezyme ( Two different formulations  of Bromelain, Trypsin and Rutoside), and compared the same against Serratiopeptidase in post-operative inflammation in subjects undergoing minor surgery and dental procedures. 1. Significantly more proportion of subjects reported with none/mild swelling or no/mild pain on Day 3 and Day 8 in treatment groups compared to Serratiopeptidase

2. Significantly more proportion of subjects reported vert good/excellent pain relief and swelling reduction on Day 3 and day 8 in treatment groups compared to Serratiopeptidase

3. 50% or more of maximum total pain relief over 8 hours from baseline was acheived with treatment groups

4. All 3 treatments were well tolerated and no significant safety concerns were noted.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study Completion: 2018-05-30
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 303

Inclusion Criteria

• 1.Subjects who have undergone one of the following (but not limited to) surgical procedures, as Day Care surgery under local or regional blocks, with or without sedation: 1.1 Minor oral surgeries (e.g. tooth extraction) 1.2Toe nail excision 1.3Lipoma excision 1.4Sebaceous cyst excision 1.5Warts excision 1.6Corn excision 1.7Ganglion excision 2.Subject is otherwise healthy and medically stable, judged by medical history, physical examination, and vital signs’ examination performed post-surgery.
• 3.Subject able to understand the purpose of the study, and willing to comply with the study procedures, in the opinion of the investigator 4.Subject willing to provide written informed consent as per current requirement of health regulatory authority.

Exclusion Criteria

• 1.Subjects who develop post-operative complication or condition which requires hospitalization for >24 hours 2.Subjects chronically receiving systemic or topical steroidal or non-steroidal anti-inflammatory agents (including study drug Phlogam®/Disperzyme®), or analgesics, and immunosuppressive agents within respective 5 half-lives prior to administration of either Phlogam®/Disperzyme® or Serratiopeptidase in the study, except paracetamol and analgesics used as part of pre- and intra-operative medication 3.Subject is allergic, hypersensitive, or intolerant to investigational products or its excipients including lactose.
• 4.Subject is contraindicated to receive Phlogam®/ Disperzyme® or Serratiopeptidase as per the local prescribing information.
• 5.Subject has history of use of recreational drugs within 12 months prior to receiving the study drugs.
• 6.Sexually active women, unless surgically sterile or post-menopausal or willing to use an acceptable method of birth control for the duration of study.
• 7.Pregnant or lactating women.
• 8.Subject has received any investigational product or used any invasive investigational medical device within 30 days before the planned first dose.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. To compare the proportion of subjects reporting no pain/mild pain	Day 3 post operative
1. To compare the proportion of subjects reporting none/mild swelling	Day 3 post operative
3.To compare the subject reported global assessment of change for pain and swelling	Day 3 post operative
4.To compare the investigator reported global assessment of change for pain and swelling	Day 3 post operative
5.To compare the number of subjects reporting any treatment emergent adverse event, any AE or SAE	Day 3 post operative

Secondary Outcome Measures

Name	Time	Method
1. To compare the events in primary outcome on Day 8 Post Operative.	2. Number of rescue medications used in either groups.

Trial Locations

Locations (9)

Ajanta Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Grant Medical College & J.J. Group of Hospitals; 🇮🇳 Mumbai, MAHARASHTRA, India

KLES Dr. Phrabhakar Kore Hospital and Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

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

Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

Rajalakshmi Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Rajiv Gandhi Medical College and Hospital; 🇮🇳 Thane, MAHARASHTRA, India

Shivam Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Shree hospital; 🇮🇳 Pune, MAHARASHTRA, India

Ajanta Research Centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Rajesh Kumar Prajapati

Principal investigator

9559782773

dr.rajeshkgmu@gmail.com