CTRI/2022/02/040687尚未招募4 期
A Prospective, Randomized, Multi-center, Open-label, Interventional Study to Evaluate the Safety and Efficacy of Imusil (Kutki Extract 200 mg plus Guduchi extract 60 mg plus Amla extract 60 mg) tablet in Treatment of Adult Subjects with mild COVID-19
Glowderma Lab Private Limited4 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Rate of SARS-CoV2 RT-PCR negativity and changes in CT value in nasopharyngeal and/or oropharyngeal swab at Day 4plus1 and Day 8plus2
研究概览
简要总结
A Prospective, Randomized, Multi-center, Open-label, Interventional Study to Evaluate the Safety and Efficacy of Imusil® (Kutki Extract 200 mg + Guduchi extract 60 mg + Amla extract 60 mg) tablet in Treatment of Adult Subjects with mild COVID-19
Primary Efficacy Outcome:
•Rate of SARS-CoV2 RT-PCR negativity and changes in CT value in nasopharyngeal and/or oropharyngeal swab at Day 4plus1 and Day 8plus2
•Proportion of subjects with a 2-point decrease in ordinal scale (as recommended by WHO) at Day 4plus1 and Day 8plus2
•Changes in blood inflammatory indexes for CRP, Interleukin IL-6, and D-Dimer at Day4plus1 and Day 8plus2.
Secondary Safety Outcomes:
•Adverse events (AEs) during the study
•Serious adverse events (SAEs) during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects of ≥18 to 60 years of age both inclusive 2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures 3.Confirmed case of COVID-19 infection by RT-PCR and mild (without any non-invasive ventilation or high flow oxygen or assisted ventilation) cases of COVID-
- •Scores of 2-3 on the WHO Eight point Ordinal Scale 4.Time interval between symptoms onset and randomization of no more than 2 days 5.One or more of the following symptoms: Fever of ≥100.4°F Cough Sore throat Headache Nasal congestion Malaise Diarrhea Loss of smell Loss of taste 6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment.
- •A subject is of child-bearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active.
排除标准
- •1.Subjects with a history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening 2.Known or suspected hypersensitivity to any herbal medication containing extracts of Kutki or Guduchi, or Amla 3.Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study 4.Men who are unwilling to use contraception while receiving investigational product 5.Subjects with a history of any severe disease which is expected to prevent compliance with the present protocol 6.Subjects with respiratory rate >24/min or with SPO2 ≤93% 7.Subjects with a history of severe renal and hepatic impairment.
- •(creatine ≥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN) 8.Recent treatment with any herbal immunomodulator in the past 7 days 9.Known history of failure to control systemic fungal, bacterial or viral infection 10.Subjects with a history of the following co-morbidities: uncontrolled diabetes, uncontrolled hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome 11.Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection 12.Have a history of neurological or psychiatric disorders, including epilepsy or dementia 13.Subjects for whom ventilator support is required at screening 14.Subjects not willing to give their informed consent to participate in the clinical trial 15.According to the Investigators judgment, there are concomitant diseases with a serious safety hazard or affect the subject 16.Using other experimental drugs or participating in other clinical trials in the prior one month.
结局指标
主要结局
Rate of SARS-CoV2 RT-PCR negativity and changes in CT value in nasopharyngeal and/or oropharyngeal swab at Day 4plus1 and Day 8plus2
时间窗: Day 4 and Day 8
Proportion of subjects with a 2-point decrease in ordinal scale (as recommended by WHO) at Day 4plus1 and Day 8plus2
时间窗: Day 4 and Day 8
Changes in blood inflammatory indexes for CRP, Interleukin IL-6, and D-Dimer at Day4plus1 and Day 8plus2.
时间窗: Day 4 and Day 8
次要结局
- Adverse events (AEs) during the study(Serious adverse events (SAEs) during the study)
研究者
研究点 (4)
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