CTRI/2017/12/010804
Completed
Phase 4
A multicentre, randomized, assessor blind, active controlled, comparative, phase IV study to assess the safety and efficacy of two fixed dose combinations (FDC) formulations of trypsin BP 48/96mg plus bromelain 90/180 plus Rutoside trihydrate BP 100/200 mg viz Phlogam and Disperzyme in post-operative inflammation in subjects undergoing minor surgery and dental procedures
Aksigen Hospital Care0 sites309 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aksigen Hospital Care
- Enrollment
- 309
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 signsâ?? 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
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
Outcomes
Primary Outcomes
Not specified
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