ITMCTR2200006369招募中未知
A multicenter, double-blinded, randomized, parallel group and placebo-controlled clinical study of the efficacy and safety of Fuzheng Jiedu granules in the treatment of COVID-19
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Traditional Chinese Medicine)0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 85（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following criteria:
- •1. SARS-CoV-2 positive;
- •2. Aged between 18 and 85 (including 18 and 85)
- •3. At the time of entry, the subject has at least one of the following clinical symptoms with a symptom score =1, including but not limited to: fever, cough, sore throat, stuffy or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or dyspnea, chills;
- •4. Subjects shall meet at least one of the following requirements: 1) The time between the samples tested positive for SARS-COV-2 and the first using of test drug is no more than 3 days; 2) =3 days from the first onset of COVID-19 symptoms to the first administration of the investigational drug;
- •5. The TCM syndrome differentiation in screening period was divided into Yang deficiency and wet toxin not clear; Symptoms: pale complexion, fear of cold, cold limbs, fatigue, chest tightness, shortness of breath, nausea, poor stomach intake, thin stools, pale and dark tongue, yellow and greasy or white and greasy coating, weak or heavy pulse.
- •6. Informed consent signed by the subject or his/her legal representative.
排除标准
- •Subjects with one of the following conditions will be excluded:
- •1. Subjects have received antiviral therapy before entry, such as Paxlovid, ritonavir, and SARS-COV-2 monoclonal antibody therapy (excluding previous treatment for COVID-19);
- •2. Subjects have received convalescent plasma from convalescent patients and other clinical trial drugs for COVID-19 indication before entering the study (excluding previous treatment for COVID-19);
- •3. Subjects have been treated with proprietary Chinese medicine or Chinese medicine prescription before entering the study (excluding previous treatment of COVID-19);
- •4. Suspected bacterial, fungal, viral or other infections other than the Novel Coronavirus during the screening period;
- •5. Subjects had bronchopneumonia, chronic lung abscess, chronic cough for more than 8 weeks, chronic pharyngitis with cough and other diseases before entering the study;
- •6. Mechanical ventilation is required or is expected to be urgently required;
- •7. In the investigator's judgment, the subject is in a death crisis or death is inevitable within the next 24 hours, regardless of treatment;
- •8. During the screening period, one of the following conditions occurs: 1) ALT or AST> 1.5x ULN; 2) eGFR < 60 ml/min. 3) Hemoglobin <8.0g/L, platelet <5000/uL;
- •9. Used other investigational drugs 30 days prior to baseline visit or during the drug's five half-lives (whichever is longer), or planned to use the drug during the study;
- •10. Subjects will participate in other clinical studies within 30 days of the screening period;
- •11. Female subjects during pregnancy, lactation or lactation;
- •12. Unable to complete the scale due to uncorrectable visual and auditory impairment;
- •13. Allergies or allergies to known research drugs;
- •14. Female subject is pregnant or breast-feeding or planning to become pregnant during the study period;
- •15. The male subject's wife or partner plans to become pregnant during the study period;
- •16. Those who are not suitable for inclusion as assessed by the researcher, such as those with obvious Yin deficiency syndrome and damp-heat syndrome.
研究者
相似试验
招募中
不适用
HIPER-500KCT0002734Samsung Medical Center120
进行中（未招募）
不适用
The aim of this clinical study is to show efficacy and safety of cells in patients suffering from stress urinary incontinence and to show superiority of cells in female patients with stress urinary incontinence over placebo.Stress urinary incontinence (SUI) of moderate severity (Grade 2 and Grade 3) in female patientsMedDRA version: 17.0Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-021871-10-ATInnovacell Biotechnologie AG - Life Science Center Innsbruck372
进行中（未招募）
不适用
The aim of this clinical study is to show efficacy and safety of cells in patients suffering from stress urinary incontinence and to show superiority of cells in female patients with stress urinary incontinence over placebo.Stress urinary incontinence (SUI) of moderate severity (Grade 2 and Grade 3) in female patientsMedDRA version: 14.1Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-021871-10-BGInnovacell Biotechnologie AG - Life Science Center Innsbruck372
进行中（未招募）
不适用
The aim of this clinical study is to show efficacy and safety of cells in patients suffering from stress urinary incontinence and to show superiority of cells in female patients with stress urinary incontinence over placebo.Stress urinary incontinence (SUI) of moderate severity (Grade 2 and Grade 3) in female patientsMedDRA version: 17.1Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-021871-10-DEInnovacell Biotechnologie AG - Life Science Center Innsbruck372
进行中（未招募）
不适用
The aim of this clinical study is to show efficacy and safety of cells in patients suffering from stress urinary incontinence and to show superiority of cells in female patients with stress urinary incontinence over placebo.Stress urinary incontinence (SUI) of moderate severity (Grade 2 and Grade 3) in female patientsMedDRA version: 18.0Level: PTClassification code 10066218Term: Stress urinary incontinenceSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2010-021871-10-CZInnovacell Biotechnologie AG - Life Science Center Innsbruck369