NCT01299402终止1 期
A Pilot Double-Blind Crossover Study on the Effects of Soulera Herbal Blend Intake on Chronic Stress and Its Biomarkers in Healthy Adults
Joseph Pergolizzi, MD2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2011年8月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Salivary Cortisol Levels
研究概览
简要总结
The purpose of the study was designed to evaluate the efficacy and safety of Soulera herbal mix in powder form and its effects on anxiety and the biomarkers for chronic stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between the ages of 21-
- •No concerns that would confound the study 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 breast feeding. Note: If the potential subject is a post-menarche female, a urine pregnancy test must be performed within 24 hours prior to study drug administration and confirmed negative in order for the potential subject to eb enrolled.
- •History of Psychiatric Illness or Chronic Stress or Anxiety
- •Hypertension, cardiovascular disease, liver, hypokalemia, or kidney disease or other health concerns that the study physician feels may confound study results
- •Individuals who are cognitively impaired or who are not able to give informed consent
- •Any routine prescription medication that the study physician feels may cause drug interaction with Soulera or alter the prescription medications' activity
- •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 uses or has used in the past 30 days any steroid formulation, be it topical like face cream, ocular as in an eye drop, nasal as in a spray, injection or pill.
- •The subject is a current smoker or uses tobacco products such as chewing tobacco.
- •The subject is actively engaging in the use of Herbal Medicine, Traditional Chinese Medicine, Ancient Indian Medicine, Yoga, or Ayurveda
- •The subject is a night-shift worker and therefore presumably has an altered cortisol diurnal rhythm and is also unable to comply with the required cortisol collection times of the study
结局指标
主要结局
Salivary Cortisol Levels
时间窗: 14 Weeks
Change in salivary cortisol as stress biomarkers for the chronic stress response following Soulera Herbal Blend intake
次要结局
- Change in chronic stress(6 times during 14 weeks)
- Quality of Life Questionaire(6 times during 14 weeks)
- Spot Urine Potassium Test(6 times during 14 weeks)
研究者
Joseph Pergolizzi, MD
Principal Investigator
NEMA Research, Inc.
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Study on the Effects of VR-3 Herbal Blend Intake on Acute and Chronic Stress in Healthy AdultsHealthy AdultsNCT00741962NEMA Research, Inc.20
已完成
2 期
A Clinical Trial on the Efficacy of a Combination Herbal Product, Biotropics' Nu Femme, on Menopausal Symptoms and Quality of Life in WomenMenopausal SymptomsNCT02269891KGK Science Inc.119
已完成
4 期
Effects of a Polyherbal Supplement on the Signs and Symptoms of Delayed Onset Muscle SorenessDelayed Onset Muscle SorenessNCT02157675NewChapter, Inc.27
已完成
3 期
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal SyndromeMenopausal SyndromeNCT00933725Guangzhou University of Traditional Chinese Medicine194
已完成
3 期
Effect of Herbal Products on Platelet Function and ClottingPlatelet Function TestNCT02008981Singapore General Hospital75