CTRI/2020/08/027120已完成3 期
An open label, double arm, multicenter, randomized, controlled, clinical study to evaluate the efficacy and safety of an anti-viral polyherbal phytochemical composition Virowin (Mfd. By Amulya Herbs, Haryana) in conjunction with multivitamin Energy Z capsules (Mkt. By Amulya Herbs, Haryana) compared with standard protocol in treating mild to moderate COVID-19 patients.
Amulya Herbs0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive).
- •2. Patients with RT-PCR confirmed diagnosis of COVID-19
- •3. Patients with mild to moderate COVID-19 infection
- •4. Subjects willing to give written informed consent
- •5. Subjects able to take the Product orally and comply with the study protocol
- •6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry
排除标准
- •1.Patients with persistent vomiting
- •2.Critically ill patients
- •3.Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections
- •4.Patients with altered mental state
- •5.Patients with multiple organ failure requiring ICU monitoring and treatment
- •6.Patients with respiratory failure and requiring mechanical ventilation
- •7.Patients with shock
- •8.Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results.
- •9.Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
- •10.Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission
- •11.Patient who have participated in another investigational study within 3 months prior to enrolment in this study
- •12.Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives.
- •13.Pregnant subjects
研究者
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