NCT02493179

Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery

Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Hayat Pharmaceutical Co. PLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) as a prospective, randomized, parallel, double blind Placebo- controlled study.

Detailed description

A prospective, randomized, parallel, double blind Placebo- controlled study to examine the efficacy of dose regimen of serratiopeptidase (serodase 5 mg) on 112 males and females volunteers in the treatment of inflammation after third molar surgery, comparing drug treatment vs placebo over a period of 20 weeks To assess the dose effectiveness of the dose regimen of Serodase 5 mg; the primary outcomes are trismus and swelling while inflammation is a secondary outcome.the expected duration of participants participation will be around 5 days divided into 4 visits, the time point of the measurment are (0,2,4 and 5 days). The results are expected to assess the improvement of the maximal interincisal distance, reduction of swelling and improvment in the sensation of post-operative pain.

Conditions

• Trismus
• Swelling
• Inflammation

Interventions

Type	Name	Description
DRUG	Serodase 5 mg	Serodase 5mg two tablets three times per day
DRUG	Placebo	Placebo two tablets three times per day

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-01-01
• Completion: 2016-02-01
• First posted: 2015-07-09
• Last updated: 2015-07-09