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临床试验/CTRI/2021/05/033790
CTRI/2021/05/033790已完成不适用

A randomized, double blind, placebo controlled, multi-centric, trial to determine the therapeutic efficacy of Ayush medicine NOQ19 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment

Sriveda Sattva Private Limited Sri Sri Tattva3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月31日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
3
主要终点
To evaluate the effect of NOQ19 in COVID 19 patients in time to become SARS COV2 RT-PCR negative, reducing the symptoms and duration of hospital stay

研究概览

简要总结

The current pandemic of Covid-19 has shaken the entire world. In spite of various scientific researches and technological advancements exact treatement to cure the disease is yet to be discovered. Ayurvedic medicine NOQ 19 is a polyherbal formulation that has immunomodulating and immune enhancing properties. This drug is licensed by Drug licensing authority, Department of AYUSH, Government of Karnataka. The present randomized, double blind, placebo controlled, multi-centric trial is planned to determine the therapeutic efficacy of Ayurvedic medicine NOQ19 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment. Three medical institutes providing Covid 19 care will be involved in conducting this trial. From each center 50 covid positive patients admitted in the hospital in the age group 18-75 years will be recruited and randomized into treatment and control arm.  Following randomization 25 of them will be given Ayurvedic medicine NOQ 19 along with standard treatment and other 25 will receive placebo plus standard treatment. The follow up period will be 7 days. Outcome measures that will be assessed are time to become SARS CoV2 RT PCR negative, reduction in symptoms and duration of hospital stay. Apart from this the blood samples will be collected on the day of entry and exit to measure CBC, RBS, KFT, LFT,  CRP.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Symptomatic COVID 19 infection with or without comorbidities Willingness to participate in the study Indian nationals.

排除标准

  • Age less than 18 years or more than 75 years Pregnancy and Lactation Patient not willing to participate in the study.

结局指标

主要结局

To evaluate the effect of NOQ19 in COVID 19 patients in time to become SARS COV2 RT-PCR negative, reducing the symptoms and duration of hospital stay

时间窗: 7 days for each participant

次要结局

  • Effect of NOQ19 therapy on laboratory parameters - CBC, RBS, KFT, LFT, CRP(Entry and Exit)

研究者

发起方
Sriveda Sattva Private Limited Sri Sri Tattva
申办方类型
Pharmaceutical industry-Indian

研究点 (3)

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