Efficacy Evaluation of the Dose Regimen of Serratiopeptidase (Serodase 5 mg Tablet) in the Treatment of Inflammation After Third Molar Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 112
- 主要终点
- Trimus by measuring the interincisal distance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants presented with impacted lower wisdom tooth needs Buccaneers flap with buccal and distal bone removal.
- •male or female 18-50
- •participant is willing and able to give informed consent for paricipation in the study.
- •Able and willing and able with all study requirments.
排除标准
- •other oral surgical procedures during the same session except the removal of supernumerary third molars.
- •female subject who is pregnant or lactating
- •subjects has participated in any clinical research study within the previous 8 weeks.
- •subjects on anti coagulant drugs .
- •Unwilling participants to continue the study and those with abnormality of wound healing process.
研究组 & 干预措施
Serodase 5 mg
Serodase ( Serratiopeptidase) 5 mg
干预措施: Serodase 5 mg (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Trimus by measuring the interincisal distance
时间窗: 5 days
the increase in the interincisal distance will show a positive effect on the Trismus
Swelling by using The Laskin method
时间窗: 5 days
the decrease in swelling will shows a positive effect on swelling based distances at predetermined time points .
次要结局
- Post-operative pain(5 days)