An open label study to evaluate the safety and tolerability of Ashwagandha extract in healthy adult volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change in the safety parameters from baseline to endpoint compared within-group at each timepoint
研究概览
简要总结
This study is an open label study to assess the safety and tolerability of Ashwagandha extract in healthy adult volunteers. A total of 62 healthy volunteers will be recruited in a single arm in the study. The healthy adult subjects between 18 to 55 years who are willing to provide a written informed consent form and meeting all the inclusion-exclusion criteria will be enrolled in study. All 62 subjects will be asked to Ashwagandha extract at dose of one capsule of 480 mg daily for 90 days with subject visits at baseline, randomization, day 30, day 60 and day 90. All the subjects will be observed for change in the safety parameters and occurrence of adverse events for product tolerability as primary outcomes of the study. AE and SAE reported by the patients will be evaluated as secondary outcomes of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females above 18 and below 55 years of age.
- •Individuals who have been tested negative for SARS-COV2 in a RT-PCR test.
- •Volunteer must be able, willing and likely to fully comply with study procedures and restrictions.
- •Voluntariness to participate in the trial and give signed informed consent.
- •No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
排除标准
- •Individuals who have been tested positive to be infected with SARS-COV2 in a RT-PCR test.
- •Patients with history of co-morbid illnesses such as cardiovascular, endocrine, renal, hepatic or other chronic disease likely to affect stress/anxiety or limit normal function.
- •Individuals with history of serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease.
- •Subjects with alcohol and/or substance dependence.
- •Subjects with known allergic reactions to test drug or any of its ingredients or any other herbal supplements.
- •Undergone surgery during last one year.
- •Individuals participating in any other clinical trial.
- •Female volunteers who are found positive in Urinary Pregnancy Test or are lactating.
- •Any condition, including laboratory abnormalities, that in the opinion of investigator places the volunteer at an unacceptable risk or deems the volunteer not suitable for participation in the study.
结局指标
主要结局
Change in the safety parameters from baseline to endpoint compared within-group at each timepoint
时间窗: Baseline, day 30, day 60 and day 90
次要结局
- Determination of tolerability of test product by observing and assessing the occurrence of adverse(events)
- Dietary intake assessment(Baseline, day 30, day 60 and day 90)
- Frequency and severity of adverse events and serious adverse events(Through-out the treatment duration till last dose)