CTRI/2020/07/026434已完成Phase 3 4
A prospective, single arm, multicentric clinical study to evaluate the safety and efficacy ofHERBOVIR syrup in subjects with upper respiratory tract infection along with standard of care
VENKAT PHARMA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年7月13日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in the Wisconsin Upper Respiratory Symptom Survey
研究概览
简要总结
Earlier clinical studies using Nutraceutical ingredients of herbal origin have demonstratedsignificant improvement in Immunity.
HERBOVIR is an herbal preparation containing multipleherbal extracts known to boost immunity.
These herbals are used for various infectious ailmentsfrom many centuries and with abundant literature evidences
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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.Subjects aged 18-65 years of age and of either sex 2.subjects who were disposed to give consent to the study and willing for follow-up 3.Subjects who are willing to sign ICF 4.Clinical signs and symptoms of an URTI with a duration of up to 24 hours accompanied with or without fever 37.5 C (axillary body temperature) or higher 5.At least 1 of 3 types of URTI symptoms – Nasal (plugged nose, runny nose, sneezing), Pharyngeal (scratchy throat, sore throat, pharyngeal hyperaemia), Cough (ordinary cough without suspicion of acute lower respiratory tract disease).
- •At least 1 of 5 general symptoms – feeling tired, weakness, body ache, irritable or whiney,or less active 6.Not be in need of hospitalized medical care at screening.
排除标准
- •1.Age less than 18 years and more than 65 years 2.Pregnancy 3.Severe or complicated course of URTI.
- •4.Signs of acute lower respiratory tract disease.
- •5.Daily use of antibiotics, steroids and cytotoxic agents.
- •6.Any uncontrolled systemic disease, infection 7.Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease• or any other disorder.
结局指标
主要结局
Change from baseline in the Wisconsin Upper Respiratory Symptom Survey
时间窗: Day 0 to Day 7
次要结局
- •Adverse events (AEs),(•frequency and severity Number of subjects who discontinue study due to adverse events)
研究者
研究点 (1)
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