Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 主要终点
- Changes of score daily measured by WURSS-K before, during and after treatment
研究概览
简要总结
The purpose of this study is to determine whether Socheongryong-tang (SCRT) and Yeongyopaedok-san (YPS) are effective in the treatment of upper respiratory tract infection.
详细描述
Upper respiratory tract infections (URTIs) are the most prevalent disease of human beings, it incur a significant health burden on populations in terms of human suffering and economic losses. Usually, antibiotic therapy is not helpful since most infections are virally induced. Over 200 serologically different viral types are responsible for human URTIs, so that preventions of URTIs including vaccination are impassable. SCRT and YPS are widely used to treat the respiratory disease. The objective of this study is to determine the efficacy of SCRT and YPS in symptomatic relief of patients with URTIs.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18~60 years old
- •Clinical diagnosis of common cold
- •Occurring no longer than 48 hours before enrollment
- •Presented with runny nose, sore throat, plugged nose, scratchy throat, cough, hoarseness, headache, muscle ache (runny nose, sore throat and at least 1 of others or 1 of runny nose, sore throat and at least 3 of others)
排除标准
- •Allergic rhinitis, asthma, COPD, sinusitis (2 and more recurrence per year), septal deviation, anatomical otitis media, exudative pharyngitis
- •Received antihistamines, NSAIDs, corticosteroids, antibiotics, decongestants
- •Hepatic cancer, liver cirrhosis, renal failure, congestive heart failure
- •Pregnant or lactation
研究组 & 干预措施
Placebo
Placebo (encapsulated starch + lactose)
干预措施: Placebo (Drug)
SCRT(Socheongryong-tang )
encapsulated Socheongryong-tang extract
干预措施: SCRT (Drug)
YPS (Yeongyopaedok-san)
Encapsulated Yeongyopaedok-san extract
干预措施: YPS (Drug)
结局指标
主要结局
Changes of score daily measured by WURSS-K before, during and after treatment
时间窗: daily (7 days)
次要结局
- Time of symptom disappearance(daily)
- Changes of score daily measured by WURSS-K before, during and after treatment in pattern identification(daily (7days))
研究者
Yang Chun Park
Professor
Korea Health Industry Development Institute