Evaluation of MetaCalm at Two Dose Levels in Healthy Adults With Acute Stress: An Open-Label, Non-Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- STAI (State-Trait-Anxiety-Inventory) questionnaire
研究概览
简要总结
This Open-Label, Non-Randomized Clinical Study involving 280 participants who will undergo a total participation of 6 hours.
详细描述
The trial begins with a screening process to assess eligibility for the study. Participants will then receive 2 or 4 MetaCalm chewable tablets, followed by a 6-hour phase during which they will be asked to complete several questionnaires at different times after taking the tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Providing written informed consent
- •Males and females of at least 18 years old
- •Obtaining a reference score of ≥ 30 on the STAI questionnaire (State-Trait Anxiety Inventory, short version, 10-item scale)
排除标准
- •Being on anxiolytic and beta blocker treatment
- •Individuals who use illicit or recreational drugs
- •Having consumed adaptogen plants in one week prior to enrollment
- •Participating in another clinical trial
- •Patients diagnosed with cancer
- •Allergic to any of the ingredients in this product
- •Obtaining a reference score of less than 30 on the STAI questionnaire (State-Trait Anxiety Inventory, short version, 10-item scale)
研究组 & 干预措施
2 chewable tablets of MetaCalm
Selection, during which eligibility to participate in the trial takes place at the start of the study: A single dose of 2 chewable tablets is administered.
干预措施: 2 chewable tablets of MetaCalm (Dietary Supplement)
4 chewable tablets of MetaCalm
Selection, during which eligibility to participate in the trial takes place at the start of the study: A single dose of 4 chewable tablets is administered.
干预措施: 4 chewable tablets of MetaCalm (Dietary Supplement)
结局指标
主要结局
STAI (State-Trait-Anxiety-Inventory) questionnaire
时间窗: 5 measurements in 6 hours
To assess the impact of MetaCalm on stress using a validated questionnaire, the State-Trait Anxiety Inventory (STAI) for adults. Depending on the patient's stress levels, scores will range from 10 to 40. The higher the score, the more stressed the patient is considered to be.
次要结局
- Hunger, appetite and craving impacts(5 measurements in 6 hours)