CTRI/2020/11/029328已完成2 期
A prospective, interventional, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of IND02 capsules (Cinamuneâ?¢) in SARS-CoV2 positive patients with mild to moderate COVID-19, managed as per the Government of India COVID-19 management guidelines, at COVID-19 management centres offering integrated Ayurvedic care.
Indus Biotech Limited0 个研究点目标入组 118 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
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 with >= 18 years and < 60 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule.
- •2.Patient with confirmed diagnosis for COVID-19, and who has tested positive for infection with SARS-CoV2 virus.
- •Note: COVID-19 infection confirmed by RT-PCR following ICMR/WHO protocol in <= 5 days prior to randomization in the study.
- •3.Patient is either requiring hospitalisation for COVID-19 or agrees to maintain a home or other quarantine as recommended by the study Investigator at the time of randomization in the study.
- •4.Patient with WHO Clinical Progression Scale score of 2 to 5
排除标准
- •1.Patients with a known history of allergy or intolerance to Cinnamon.
- •2.Participation in another concurrent clinical trial for COVID-19 or in any other trial within the 6 months prior to this study enrolment.
- •3.Patients classified as severe or critical COVID-19 patients as per AYUSH guidelines.
- •4.Patients with pre-existing respiratory conditions, or with severe primary respiratory disease or other pneumonia, who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion.
- •5.Patients with other serious diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion.
- •6.Patients requiring mechanical ventilation at screening.
- •7.Patients with uncontrolled and unstable comorbid conditions.
- •8.Immunocompromised individuals or patients who are already receiving immunosuppressant therapies.
- •9.Patients who are currently on or may require parenteral nutrition during the course of the study.
- •10.Female patients who are breastfeeding or pregnant at the time of enrolment in the study.
- •11.Female patients of childbearing potential who, within 4 weeks prior to study enrolment, did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the study period.
- •12.Any medical or other condition that in the opinion of the Investigator would preclude the patientâ??s participation in the study.
- •13.Current abuse of alcohol; and current or past (last 12 months) abuse of drugs.
研究者
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