Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Virological Clearance as measured by RT PCR of nasopharyngeal swab
研究概览
简要总结
COVID-19 infection is known to affect individuals with weak immunity more severely. Therefore, enhancing immunity is definitely one of the ways the doctors across the globe have been using for treating COVID-19 cases.
The study is Interventional Randomized parallel group placebo controlled, Single Centric trial in which Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) will be accessed.
To combat COVID-19 virus with Ayurveda, we have screened close to 1000 phytochemicals from more than 100 medicinal plants, in-sillico. We looked for their binding affinities to COVID-19 essential proteins and host protein interactions. We have discovered that natural phytochemicals in Ashwagandha, Giloy and Tulsi indeed have potentials to combat COVID-19 and its pathogenicity.
The patients who will be included in the study’s active control group will receive -
Tablet Swasari Ras : (500 mg)
Tablet Pure Ashwagandha Extract : (500 mg)
Tablet Pure Giloy Extract : (500 mg)
Tablet Pure Tulsi Extract : (500 mg)
Anu Taila (Nasal drop)
The above mentioned ayurvedic medicines will be used at following dosage :
In the morning:
At-least 60 mins before break-fast : 4 drops of Anu Taila (Nasal drop), in each nostril.
At-least 30 mins before break-fast : Swasari Ras 2 gm (with luke-warm water)
At-least 30 mins after break-fast : 2 Tablets Pure Giloy Extract
1 Tablet Pure Ashwagandha
1 Tablet Pure Tulsi Extract (with luke-warm water)
In the evening:
At-least 30 mins before dinner : Swasari Ras 2 gm (with luke-warm water)
At-least 30 mins after dinner : 2 Tablets Pure Giloy Extract
: 1 Tablet Pure Ashwagandha
1 Tablet Pure Tulsi Extract (with luke-warm water)
The above mentioned active control group will be compared with Placebo group receiving placebo of same dosage form. Symptomatic treatment will follow in both group along with treatment.
The primary outcome of the study will be assessed by measuring virological clearance as measured by RT PCR for nasopharageal swab at baseline, 3rdday, 7thdays and 14th day.
The secondary outcomes will be assessed by measuring conversion from symptomatic to asymptomatic patient, reduction in CRP protein, ESR & IL-6. Further improvement in hematological parameter, Total leucocyte count and lymphocyte count. Safety analysis will also be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
入排标准
- 年龄范围
- 15.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Asymptomatic patients Mildly symptomatic patients Moderately symptomatic patients Age 15-80 years of age Patients able to give Informed consent and follow instructions Agree to follow at 14 days and 30 days after testing positive for COVID-19.
排除标准
- •Severely symptomatic patients (SaO2 <90%) Acute Respiratory Distress Syndrome (ARDS) Life expectancy less than 1 year due to other co-morbid conditions.
结局指标
主要结局
Virological Clearance as measured by RT PCR of nasopharyngeal swab
时间窗: Baseline, 3 Days, 7 Days, 14 Days
次要结局
- Conversion from Symptomatic to Asymptomatic patient(Reduction in C-reactive protein, ESR & IL-6)
