A randomized, double blind, placebo controlled, trial to determine the therapeutic efficacy of Ayush medicine NF2 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the effect of NF2 in COVID 19 patients as time to become COV2 RT-PCR negative, duration of hospital stay, time to resolution of symptoms
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 treatment to cure the disease is yet to be discovered. Ayurvedic medicine NOQ 19 is a polyherbal formulation that has immunomodulating and immune enhancing properties. The present randomized, double blind, placebo controlled, multi-centric trial is planned to determine the therapeutic efficacy of Ayurvedic medicine NF2 (NOQ19) in treatment of symptomatic COVID-19 patients along with standard allopathic treatment. GIMS providing COVID-19 Care will be involved in conducting this trial. Admitted positive patients admitted in the hospital in the age group 18-65 years will be recruited and randomized into treatment and control arm. Following randomization 50 of them will be given Ayurvedic medicine NAOQ19 along with standard treatment and other 50 will receive placebo plus standard treatment. The follow up period will be for maximum of 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 at entry and exit to measure CBC, KFT, LFT, serum CRP
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Hospitalized or in home isolation adult patient aged >18 years Confirmed COVID-19 infection (RT –PCR- Upper respiratory tract nasopharyngeal and oropharyngeal swab.
- •mild and moderate 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 Pregnancy and Lactation Moribund state in which death is perceived to be imminent (≤48 hours) Patient not willing to participate in the study Participation in any other clinical study.
结局指标
主要结局
To evaluate the effect of NF2 in COVID 19 patients as time to become COV2 RT-PCR negative, duration of hospital stay, time to resolution of symptoms
时间窗: 7 days for each participant
次要结局
- Effect of NF2 therapy on laboratory parameters - CBC, CRP, LFT, KFT(Entry and Exit)