Efficacy Evaluation of the (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
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|ClinicalTrials.gov Identifier: NCT02493179|
Recruitment Status : Unknown
Verified July 2015 by Hayat Pharmaceutical Co. PLC.
Recruitment status was: Not yet recruiting
First Posted : July 9, 2015
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Trismus Swelling Inflammation||Drug: Serodase 5 mg Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||February 2016|
Active Comparator: Serodase 5 mg
Serodase ( Serratiopeptidase) 5 mg
Drug: Serodase 5 mg
Serodase 5mg two tablets three times per day
Other Name: Serratiopeptidase 5 mg tablets
Placebo Comparator: Placebo
Placebo two tablets three times per day
Other Name: Placebo tablets
- Trimus by measuring the interincisal distance [ Time Frame: 5 days ]the increase in the interincisal distance will show a positive effect on the Trismus
- Swelling by using The Laskin method [ Time Frame: 5 days ]the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .
- Post-operative pain [ Time Frame: 5 days ]pain will be measured using the numerical pain scale from (0-10) after surgery.