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 Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •1.Male or female subjects of ââ?°Â¥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-19. 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 ââ?°Â¥100.4Ã?°F
- •Sore throat
- •Nasal congestion
- •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 ââ?°Â¤93%
- •7.Subjects with a history of severe renal and hepatic impairment. (creatine ââ?°Â¥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.
研究者
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