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 个研究点目标入组 309 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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
•4.Subject willing to provide written informed consent as per current requirement of health regulatory authority.

•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 PhlogamÂ®/DisperzymeÂ®), or analgesics, and immunosuppressive agents within respective 5 half-lives prior to administration of either PhlogamÂ®/DisperzymeÂ® 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 PhlogamÂ®/ DisperzymeÂ® 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

发起方

Aksigen Hospital Care