跳至主要内容
临床试验/CTRI/2020/10/028570
CTRI/2020/10/028570尚未招募2/3 期

An interventional, single arm study to observe and assess the effectiveness of “Vyaghradi Kashaya Tab†in preventing the progression of severity in asymptomatic, mild to moderate COVID-19 cases.

Ministry of AYUSH Govt of India1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年5月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Time taken to be tested negative for SARS-CoV2 in RT-PCR.

研究概览

简要总结

Coronavirus (COVID-19) is a pandemic started from Wuhan City of  China in December 2019, with the case of Pneumonia with unknown cause later on in the mid of January 2020 it was declared as an emergency. There are Numerous studies have been published, establishing evidence and opinion-based guides current COVID-19 pandemic, which has taken the world by storm. The sudden outbreak of COVID-19 making society of the people realizes the threat of communicable diseases to human being. A whole-of-society approach is needed to tackle 21st century epidemics so that all the different type of epidemic disease is to be taken into consideration. Genetics and biological factors, ecology and the physical environment; are also affecting causes. This increasing convergence of many factors that requires multi-disciplinary, multi-sectoral and multi-faceted approaches. Ayurved can be helpful in pandemic disease like COVID-19. In COVID patients Cough and sputum, Chest tightness, Difficulty breathing, Fever, Fatigue, Nasal congestion, runny nose, Sick and vomiting are the common symptoms. Vyaghradi Kashaya is indicated in Vatshleshmak jwara having the symptoms like cough, running nose, breathlessness. Therefore, the proposed study is designed to search out the effectiveness of Vaghradi Kashay in asymptomatic and mild to moderate cases of COVID-19. The composition of the drug is Kantakari (Solanum xanthocarpum), Sunthi (Zingiber officinale), Amruta (Tinospora cordifolia), Pippali (Piper longum).These drugs have antiviral, antibacterial, antioxidant and immunomodulator property.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or with mild to moderate symptoms.
  • All the patients of age group 18-65 yrs All those who are willing to give written consent for participation in the study.

排除标准

  • COVID patients with symptoms classified as severe or critical.
  • Persons with severe primary respiratory disease or other pneumonia Pregnant and lactating women Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., and who are considered to be excluded from the study as evaluated by the investigators COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials.

结局指标

主要结局

Time taken to be tested negative for SARS-CoV2 in RT-PCR.

时间窗: a)RT PCR 7th and 14th Day | b)Assessment of clinical recovery at baseline, Daily 7-14 days

To Assess the effect of drug in preventing the progression of severity of symptoms.

时间窗: a)RT PCR 7th and 14th Day | b)Assessment of clinical recovery at baseline, Daily 7-14 days

次要结局

  • Secondary outcome-(To assess the effect of Vyaghradi Kwath Tab on blood parameters specific to Covid-19.)

研究者

发起方
Ministry of AYUSH Govt of India
申办方类型
Other [Ministry of AYUSH Govt of India]

研究点 (1)

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