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临床试验/CTRI/2020/05/025273
CTRI/2020/05/025273已完成不适用

Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19)

Patanjali Research Institute1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年5月29日最近更新:

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)

研究者

申办方类型
Research institution

研究点 (1)

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