An open label, single arm, single-center and prospective pilot study to evaluate the efficacy and safety of Koff-N-Cold tablets in Mild to Moderate COVID-19 Positive Participants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Covid-19 symptoms like Fever,Vomiting, Nausea, Diarrhea, sense of smell, sense of taste, etc. as per COVID-19 questionnaire.
研究概览
简要总结
Coronavirus Disease 2019 (COVID-19), caused by the SARS-CoV-2 virus, has posed significant challenges to global health since its emergence. While vaccines and various therapeutic agents have been developed, the search for safe and effective treatments—particularly for mild to moderate cases—remains ongoing to reduce symptom burden and disease progression.
Koff-N-Cold tablets, a polyherbal formulation traditionally used for the management of upper respiratory tract infections, possess potential antiviral, anti-inflammatory, and immunomodulatory properties. Given their pharmacological profile, Koff-N-Cold tablets may offer supportive treatment benefits in managing COVID-19-related symptoms.
This open-label, single-arm, single-center, and prospective study is designed to evaluate the efficacy and safety of Koff-N-Cold tablets in COVID-19 positive participants with mild to moderate symptoms. The findings may contribute to the evidence base for integrating supportive herbal formulations in the clinical management of COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female aged 18–65 years.
- •Participants with confirmed COVID-19 (RT-PCR positive) with mild to moderate symptoms (RT-PCR positive report will be accepted within 72 hours prior to screening) 3.Participants with symptom onset within the past 5 days.
- •4.Participants with Oxygen saturation (SpO2) greater than 94 percent on room air.
- •5.Willing to provide written informed consent.
排除标准
- •Participants with any of the following conditions will be excluded from the study.
- •1.Participants with severe COVID-19 requiring hospitalization.
- •2.Pregnant or breastfeeding women.
- •3.Participants with history of hypersensitivity to any herbal components.
- •4.Concurrent participation in another clinical trial.
- •5.Participants with any co-morbid conditions.
- •6.Participants with chronic respiratory diseases requiring daily medication.
结局指标
主要结局
Change in Covid-19 symptoms like Fever,Vomiting, Nausea, Diarrhea, sense of smell, sense of taste, etc. as per COVID-19 questionnaire.
时间窗: Time Frame: Day 1, Day 3, Day 5, Day 7 & Day 15
次要结局
- The secondary endpoints is to evaluate the-(1.Time of complete resolution of cough, sore throat, & nasal congestion.)
研究者
Dr Himanshu Shukla
PGH Hospital Private Limited