NCT00741962已完成不适用
A Pilot Double-Blind Crossover Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress and Their Biomarkers in Healthy Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in salivary alpha-amylase and cortisol as stress biomarkers for the acute and chronic stress response following VR-3 Herbal Blend use
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of VR-3 Herbal Blend and its effects on acute and chronic stress responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between the ages of 35-45
- •No health concerns as determined by study physicians
- •Women must not be pregnant or become pregnant for the duration of the study.
排除标准
- •The subject has a history of hypersensitivity to any of the compounds used in the study
- •The subject is pregnant or a lactating female. Note: If the potential subject is a post-menarcheal female, a pregnancy test (urine or serum) must be performed within 24 hours of study drug administration and confirmed negative in order for the potential subject to be enrolled).
- •History of Psychiatric Illness or Chronic Stress or Anxiety
- •Hypertension, cardiovascular disease, or other health concerns that may confound study results
- •Allergy or sensitivity to test product or ingredients
- •Individuals who are cognitively impaired or who are not able to give informed consent
- •Clinically significant or abnormal laboratory result that can confound the study
- •Medication or nutraceutical intake that can interact with the adaptogens or the biomarkers used in the study (to be determined by study physician)
- •Previous participation in a clinical research trial within 30 days prior to randomization
- •The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.
- •The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
研究组 & 干预措施
1
Experimental
干预措施: VR-3 Herbal Blend (Dietary Supplement)
2
Placebo Comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in salivary alpha-amylase and cortisol as stress biomarkers for the acute and chronic stress response following VR-3 Herbal Blend use
时间窗: 10 weeks
次要结局
- Change in acute psychological stress(10 weeks)
- Change in chronic stress(10 weeks)
研究者
研究点 (1)
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