Evaluation of Ashwagandha (Withania Somnifera) Standardized Extract for its effect on quality of life (QoL) in patients during post-COVID19 period: A Prospective, Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeks
研究概览
简要总结
A Prospective, Randomized, Placebo-Controlled Study of Ashwagandha Standardized Extract (KSM66) for its effect on quality of life (QoL) in patients during post-COVID19 period.
COVID-19 is a disease caused by the SARS-CoV-2 virus. It infects the respiratory tract. Some people who get COVID-19 have only mild symptoms. But for others, infection leads to pneumonia, respiratory failure, and, in some cases, death. Researchers want to learn more about any potential beneficial effects of ashwagandha in people who recover from COVID-19.The purpose of this study is to evaluate any potential benefits of Ashwagandha in patients who have recovered from COVID-19 in improving their overall quality of life.
The study assessments to be done by SP-36, Hamilton anxiety Rating scale (HAM-A) ,HAM-D throughout the study period till week 12 and CareFusion Vyntus CPX metabolic system (CareFusion Germany 234 GmbH) at screening and week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender, aged 18 to 50 years
- •All adult patients aged ≥18 years who present to the site for follow-up OPD
- •Laboratory-confirmed COVID-19 infection with SARS-CoV-2
- •Subjects able to understand and complete the study questionnaires
- •Subjects who sign the informed written consent.
排除标准
- •Patients aged below 18 years will be excluded.
- •Unwilling or unable to provide written informed consent,
- •Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening.
- •Those who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent.
结局指标
主要结局
Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeks
时间窗: screening, week 4, week 8 and week 12
次要结局
- Change in scores for HAM-D at the end of 12 weeks(screening, week 4, week 8 and week 12)
- Change in scores for HAM-A at the end of 12 weeks(screening, week 4, week 8 and week 12)
- Changes in Cardio-Pulmonary Exercise Testing (CPET) results at the end of 12 weeks(screening and week 12)