Health Condition 1: T80-T88- Complications of surgical and medical care, not elsewhere classified Health Condition 2: null- Patients with post operative inflammation who have undergone minor surgical procedures, as Day Care surgery under local or regional blocks, with or without sedation including dental procedures
Conditions
Interventions
Intervention1: Phlogam®: contains
Trypsin B.P. 48 mg
Bromelain 90 mg
Rutoside trihydrate B.P. 100 mg
2 tablets - three times a day for 7 days
Intervention2: Disperzyme: contains
Trypsin B.P. 96 mg
Sponsors
Aksigen Hospital Care
Bharat Serums and Vaccines Ltd
Eligibility
Inclusion 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) 1.2 Toe nail excision 1.3 Lipoma excision 1.4 Sebaceous cyst excision 1.5 Warts excision 1.6 Corn excision 1.7 Ganglion 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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To compare the proportion of subjects reporting none/mild swelling 2. To compare the proportion of subjects reporting no pain/mild pain 3. To compare the subject reported global assessment of change for pain and swelling 4. To compare the investigator reported global assessment of change for pain and swelling 5. To compare the number of subjects reporting any treatment emergent adverse event, any AE or SAETimepoint: Day 3 post operative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the events in primary outcome on Day 8 Post Operative. 2. Number of rescue medications used in either groups.Timepoint: Day 8 of Post Operative | — |
Countries
India
Contacts
Public ContactDr Ganesh Divekar
Bharat Serums and Vaccines Ltd
Outcome results
None listed