JPRN-jRCT2031210063进行中（未招募）1 期
The exploratory study investigating the efficacy and safety of Ephedrine alkaloids-free Ephedra Herb extract (EFE) in patients with COVID-19 in the early stages of infection- Double-blind, randomized, multicenter Phase I / II controlled trial
Odaguchi Hiroshi0 个研究点目标入组 156 人开始时间: 2021年4月30日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •(1) Subjects who can obtain written consent, based on their free intention
- •(2) Subjects whose age at the time of obtaining consent is 20 years or older and under 80 years
- •(3) Subjects who are SARS-CoV-2 positive by PCR or antigen test within 3 days before baseline-test
- •(4) Subjects whose COVID-19 symptoms (upper respiratory tract inflammation such as fever and cough) appiered within 7 days before baseline-test and mild (Resting SpO2 96% or more)
- •(5) Subjects who were judged no problem by the investigator to participate in this clinical trial based on medical examination, vital signs, laboratory test values, chest X-ray, etc.
排除标准
- •(1) Subjects who participated in other clinical studies and clinical trials within 12 weeks before the start of study drug administration. And subjects who are planning to participate in clinical studies and clinical trials of unapproved drugs during this study period.
- •(2) Subjects who administered therapeutic medication for COVID-19 within 7 days before the start of study drug administration.
- •(3) Subjects without symptoms due to COVID-19 (upper respiratory tract inflammation such as fever and cough)
- •(4) Subjects whose infection episode is recurrence or reinfection of SARS-CoV-2
- •(5)Subjects who cannot interrupt the administration of prohibited drugs specified in the clinical trial protocol during the study period
- •(6)Subjects with SpO2 less than 96% without oxygen therapy
- •(7) Subjects with serious or uncontrolled underlying disease, e.g. chronic obstructive pulmonary disease, chronic kidney disease, hepatic dysfunction, diabetes mellitus, hypertension, cardiovascular disease, malignant tumor, body mass index; BMI 30 or higher obesity (not excluded if the disease are mild and controlled)
- •(8) Subjects with impaired consciousness such as the disorientation
- •(9) Subjects with hypersensitivity to Ephedra Herb or Kampo medicines containing Ephedra Herb
- •(10)Pregnant women, subjects who are breastfeeding or may be pregnant
- •(11) In the case the subject is women who can pregnant, whose pregnancy test is positive For both men and women, subjects who do not agree to perform contraception during the clinical trial.
- •(12) Subjects with pacemakers
- •(13) Subjects who have cohabitant participating or have participated in this clinical trial.
- •(14) Subjects who judged by the investigators to be ineligible
研究者
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