Phase II, open label, randomized controlled trial to evaluate safety and efficacy of ShatPlus as an immunomodulator in adult Covid 19 positive patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19
研究概览
简要总结
The coronavirus disease 2019 (COVID-19) is a global pandemic. Presently there is a quest of an
appropriate treatment which could arrest the fatality of the disease and also enhance the recovery
rate of the affected individuals. With years of rigorous R&D, BVG has developed ShatPlus
formulation, having immune-modulatory, anti-viral, immune-stimulant, anti-inflammatory and
anti-oxidant effects studied through scientific validation. The Ayurvedic ingredients used in the
above formulation are scientifically reported to have anti-viral effects. BVG Life Sciences Limited
herewith has planned clinical trial to clinical validate “ShatPlusâ€, an ayurvedic proprietary
medicine against COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted with RT-PCR confirmed COVID-19 illness.
- •Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8) Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations.
排除标准
- •Pregnant women Breastfeeding women Requiring ICU admission at screening Patients above 65 years of age and below 18 Years Past History of MI, Epileptic episodes Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening Any other condition by which subject proves unfit from investigator perspective Not giving consent.
结局指标
主要结局
No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study
Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study
Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study
Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale
时间窗: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study
次要结局
- Change in National Early Warning Score(Hematological parameters like WBS, HB and platelet count etc.)