A Randomized, Double-blind, Placebo-controlled Study to Evaluate the effect of an Ayurvedic Regimen administered in nCoV-2 (COVID – 19) Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Mean time (days) for clinical recovery.
研究概览
简要总结
This is a randomized, double-blind, parallel-group placebo-controlled interventional study. To combat the COVID-19 virus with Ayurveda, we discovered that natural phytochemicals in Ashwagandha, Giloy, and Tulsi indeed have the potentials to combat COVID-19 and its pathogenicity.
The investigational regime comprises of Divya Coronil Tablets, Divya Swasari Vati which are oral tablets and the product is Anu tail which is a liquid dosage form in form of nasal drops.· To render the proportion of patients showing clinical improvement in mild, moderate and severe COVID-19 cases. The patients will be divided into 2 categories. Category I patients will receive standard COVID-19 treatment along with the experimental ayurvedic medicine while category II patients will receive standard COVID-19 treatment along with placebo.
Primary Endpoint**:**To get CT value of RT-PCR / RT- PCR negative.
**Secondary Endpoints:**To get normal or near-normal values of important markers like CRP, IL6 and TNFα., Length of time to clinical improvement/disease progression.
These details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 and Day 14 or the day of discharge and on one follow up visit on Day 28.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18- 60 years of both male and female gender.
- •Laboratory confirmed COVID-19 patients determined through (RT-PCR).
- •Patient consenting to participate in the study and follow instructions.
- •Agree to attend hospital for follow up on predetermined schedule.
排除标准
- •Laboratory confirmed COVID-19 asymptomatic cases.
- •Patients on parenteral nutrition.
- •Pregnant and lactating mothers and those who have pregnancy plan.
- •Person with serious critical illness like End stage liver or renal disease, Coronary artery disease, Stroke or Renal tubular acidosis.
- •Participants with any immunosuppressive medication or in an immune compromised state or hematological disease.Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind.
结局指标
主要结局
Mean time (days) for clinical recovery.
时间窗: Details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 ,Day 14 and on one follow up visit on Day 28.
To render proportion of patient showing clinical improvement in mild, moderate and severe COVID-19 cases.
时间窗: Details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 ,Day 14 and on one follow up visit on Day 28.
次要结局
- To restore health and reduction in serum viral load.(Rate of patients with negative SARS-CoV2 on nasal or throat swab RT-PCR test.)