A clinical study to evaluate safety of standardized Ashwagandha (Withania somnifera) extract capsules in healthy male volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 1. Clinical laboratory examination of complete blood count (CBC), lipid profile, thyroid profile, liver function test (LFT), kidney function test (KFT), urine analysis, serum B12 levels, and CRP from screening to end of the study.
研究概览
简要总结
Herbal nutraceuticals and functional foods have gained worldwide popularity since last decade due to increasing awareness about health among consumers. Withania somnifera (Ashwagandha), also known as “Indian Winter Cherry†is a valuable herb used as “Rasayana†to promote a youthful state for physical and mental health for over 3000 years. Roots of Withania somnifera have been used to prepare a tonic that enhances longevity, revitalizes the body, arrests the aging process and augment a defense against dreadful diseases, such as cancer, alzheimer’s and epilepsy. Withania species consist of chemical constituents from diverse chemical classes. Gaining knowledge and validating safety of active ingredients after oral administration is always of a great interest for food / nutritional products containing Withania somnifera.
The investigational product is formulated from the extract of Withania somnifera roots. The capsule containing single dose of 500 mg of standardized Withania somnifera root extract have been formulated for oral administration. The investigational product is Ayurvedic Proprietary Medicine and is considered and found to be safe to administer healthy human subjects. Considering the objective of interest as safety, the healthy human volunteers are proposed as study population for this study.
The present research is an attempt evaluate safety of Withania somnifera extract capsules in healthy male volunteers.
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 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male subjects having age between 18 to 60 years (both inclusive)
- •BMI between 18.5 and 24.9 kg/m2 (both inclusive)
- •Apparently mentally and physically healthy and biochemical parameters within normal reference ranges
- •Willingness to complete the study interventions and follow-up
- •Subjects with normal cardiovascular function with no evidence of acute ischemic heart disease in the electrocardiogram
- •The subject willing to provide consent and visit on follow up and abide protocol related requirements.
排除标准
- •Being on a medically prescribed drug or supplements
- •Reported weight loss/gain >10% of body weight in the 6-month preceding pre-study examination
- •Using herbal supplements or dietary supplements meant for improving health and wellbeing
- •History of hypersensitivity to Ashwagandha
- •Undergoing medical treatment that may interfere with the study outcome
- •Consuming alcohol, smoking and/ or chewing tobacco during the past 6 months
- •Recreational drug use during the past 6 months
- •Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator
- •Any other major clinical disease or psychiatric disorder that, at the discretion of the investigator, precludes the administration or completion of the protocol treatment.
结局指标
主要结局
1. Clinical laboratory examination of complete blood count (CBC), lipid profile, thyroid profile, liver function test (LFT), kidney function test (KFT), urine analysis, serum B12 levels, and CRP from screening to end of the study.
时间窗: Screening visit, Baseline, | Visit 2(Day 15), Visit 3(Day 31)
2. Observations in x-ray and ECG from screening to end of the study.
时间窗: Screening visit, Baseline, | Visit 2(Day 15), Visit 3(Day 31)
3. Vital signs from screening to end of the study.
时间窗: Screening visit, Baseline, | Visit 2(Day 15), Visit 3(Day 31)
次要结局
- 1. Cardiorespiratory endurance by step test at screening and end of the study.(2. Body fat percentage and lean body weight by measuring skinfold thickness at four areas such as biceps, triceps, subscapular, and suprailiac with a Skin Fold Caliper in millimeters at screening and end of the study.)