CTRI/2017/10/010004招募中4 期
A Multicentric, Open label, Randomized, Comparative, Clinical Study evaluating Safety and Efficacy of Fixed Dose Combination of Trypsin 96 mg plus Bromelain 180 mg plus Rutoside Trihydrate 200 mg enteric coated tablet versus Chymoral Forte (Trypsin - chymotrypsin (1,00,000 AU)) enteric coated Tablet in patients for healing potential in surgical wounds after minor surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 383
- 试验地点
- 13
- 主要终点
- 1. To evaluate safety and tolerability in patients with surgical wounds after minor surgery. Incidence of adverse events and serious adverse events.
研究概览
简要总结
This Multicentric,Open label, Randomized, Comparative, Clinical Study will evaluate Safety andEfficacy of Fixed Dose Combination of Trypsin 96 mg + Bromelain 180 mg +Rutoside Trihydrate 200 mg enteric coated tablet versus Chymoral Forte (Trypsin - chymotrypsin (1,00,000 AU)) entericcoated tablet in patients for healing potential in surgical wounds afterminor surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients who are 18 to 65 years of age with surgical wounds after minor surgery.
- •2.Patients able to follow all study directions and commit to come at all follow-up visits as per the protocol.
- •In addition, subjects must be willing to accept the restrictions of the study.
- •3.Subjects have the willingness and ability to understand and provide written informed consent to participate in the study.
排除标准
- •1.Patients with Uncontrolled diabetes mellitus or any other metabolic disorder.
- •2.Patients with known hypersensitivity to any of the study related drugs.
- •3.Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis.
- •4.Patients taking medicines such as tetracycline group of drugs, amoxicillin, aspirin, anticoagulants including clopidogrel should be excluded.
- •5.Patients who are currently enrolled in another clinical investigation or have been enrolled in any surgical wound trial within a period of 30 days prior to enrollment in this study.
- •6.Women of child bearing age not using any contraceptive.
- •7.Pregnant or nursing women.
- •8.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
结局指标
主要结局
1. To evaluate safety and tolerability in patients with surgical wounds after minor surgery. Incidence of adverse events and serious adverse events.
时间窗: For 1: Day 5, 10. | For 2: Baseline, Day 10.
Safety will be evaluated based on the adverse events reported and their plausible causal relationship with the study drug.
时间窗: For 1: Day 5, 10. | For 2: Baseline, Day 10.
2. Laboratory Investigations:
时间窗: For 1: Day 5, 10. | For 2: Baseline, Day 10.
Hematology; Biochemistry.
时间窗: For 1: Day 5, 10. | For 2: Baseline, Day 10.
次要结局
- Number/percentage of patients with complete wound regeneration on day 5 and 10
- BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) score(Baseline, day 5, 10)
- Patient and investigator global efficacy impression(Day 10)
研究者
研究点 (13)
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