Efficacy and Safety of Silfamin for Common Cold With or Without Sore Throat: Preliminary Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Score of common cold and sore throat
研究概览
简要总结
This is a 2-arm, prospective, randomized, double-blind, placebo-controlled, and three-days-treatment clinical study comparing the efficacy and safety of Silfamin at a dose of 2 tablets@150 mg twice daily in subjects with common cold.
详细描述
There will be 2 groups of treatment; each group will consist of 30 subjects receiving the following regimens for three days:
Treatment I : 2 tablets of Silfamin 150 mg 2 times daily Treatment II : 2 tablets of Placebo 2 times daily
Eligible subjects will be evaluated for treatment efficacy at 0 hours (just before drug administration), 1 and 2 hours after the first dose. For the next doses, subject will perform a self-assessment for treatment efficacy at 1 and 2 hours after every dosing, and record it in subject's diary.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy (by anamnesis) men or women aged 18 to 60 years with mild or moderate common cold with or without sore throat (Common cold Score of 1 or 2)
- •Willing to participate in the study by signing the informed consent
排除标准
- •Body temperature of > 37.3˚C and/or refuse to follow health protocol for COVID-19
- •Known hypersensitivity to herbal drugs containing Nigella sativa and/or Phaleria macrocarpa
- •Pregnant or lactating women
- •Have received any analgesic, anti-inflammatory or other common cold preparation within the past 24 hours
- •Presence of vomiting or diarrhea within the past 24 hours and still ongoing at the start of study
- •Severe illness, e.g. severe hypertension (> 160/100 mmHg)
研究组 & 干预措施
Silfamin
2 tablets of Silfamin 150 mg twice daily
干预措施: Silfamin (Drug)
Placebo
2 tablets of Placebo twice daily
干预措施: Placebo tablet of Silfamin (Drug)
结局指标
主要结局
Score of common cold and sore throat
时间窗: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
Score of common cold and sore throat measured at 0 hours (just before drug administration) for the first dose, 1 and 2 hours after every dosing
VAS score of sore throat
时间窗: 30 minutes, 60 minutes, 90 minutes, 2 hours, 1 day, 2 days, 3 days
VAS score of sore throat measured at 0 hours (just before drug administration), 1 and 2 hours after every dosing
次要结局
- Adverse events(1, 2, 3 days)