CTRI/2022/01/039548已完成不适用
A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation(ASVAMAN®) on Improvement of Energy and Endurance in Adults
Manipal Natural Private Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月24日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline to the end of the study period in Serum Cortisol
研究概览
简要总结
This is a Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Ashwagandha Extract Formulation (ASVAMAN®) on Improvement of Energy and Endurance in Adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •Male healthy adult subjects ranging in age from 18 to 50 years.
- •Willingness to follow the protocol requirements as evidenced by written, informed consent.
- •Mentally, physically and legally eligible to give informed consent
- •Male subjects BMI between 20.0 – 25.9 kg/m2
- •Willingness to complete study questionnaires.
排除标准
- •Patients with pre-existing severe systemic disease necessitating long-term medication.
- •Significant medical or psychiatric illness
- •History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ
- •Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments
- •Participation in the current or previous treatment with any approved or investigational health supplement(s) during the past 1 month.
- •Subjects received other medication (anti-viral) within the 36 hours before entry into the study
- •Patients who had immunization against influenza or influenza like illnesses for that season.
- •Inability to comply with the study protocol, including psychiatric diseases.
- •Immune compromised or with other clinically active illness including cardiac or pulmonary diseases, hemoglobinopathies, renal dysfunction
- •Having vaccination of a seasonal or new influenza A (H1N1) vaccine 6 months before.
- •Other reasons that researchers think not fitting to participate in the study
- •Evidence of significant uncontrolled comorbid disease which in the investigators opinion would jeopardize patient participation.
- •Patient tested positive with Covid 19.
结局指标
主要结局
Change from baseline to the end of the study period in Serum Cortisol
时间窗: Day 0 and Day 42
次要结局
- Change from baseline to the end of the study period in One Leg Stand Test(Day 0, Day 21 and Day 42)
- Change from baseline to the end of the study period in Testosterone(Day 0 and Day 42)
- Change from baseline to the end of the study period in Six Minutes’ walk test(Day 0, Day 21 and Day 42)
- Change from baseline to the end of the study period in Stair Climb Test(Day 0, Day 21 and Day 42)
- Change from baseline to the end of the study period in 30 Meter walk test(Day 0, Day 21 and Day 42)
- Change from baseline to the end of the study period in Chair Stand Test(Day 0, Day 21 and Day 42)
- Change from baseline to the end of the study period in Quality of Life – SF 36(Day 0, Day 21 and Day 42)
研究者
研究点 (1)
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