NCT06177535进行中（未招募）不适用
The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in Cortisol
研究概览
简要总结
This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Surgical services nurses at Mayo Clinic in Rochester, MN.
- •Able to participate fully in all aspects of the study.
- •Willing to use birth control for the duration of the study (if of childbearing potential).
- •Understood and signed study informed consent.
排除标准
- •Pregnant, nursing, or trying to conceive.
- •Persons with a menstrual cycle who are not willing and able to use an approved contraceptive during the study (female sterilization (tubal ligation, hysterectomy), IUD or another implant, oral or injectable contraceptive, contraceptive patch/ring, diaphragm/cervical cap, male sterilization (vasectomy), male condom, female condom, sponge/spermicide) (Persons who do not have sex with men can participate without the use of an approved contraceptive).
- •Use of kava or kava-containing products within the past 8 weeks.
- •Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers).
- •Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study.
- •Use of oral corticosteroids (e.g., hydrocortisone) or other steroids (e.g., prednisone).
- •Alcohol use greater than 1 drink per day.
- •Use of kratom within the past 8 weeks.
- •Recent history of clinical depression or anxiety diagnosis.
- •Known significant liver disease or dysfunction.
- •Known significant kidney disease or dysfunction.
- •Known Addison's or Cushing's Disease.
- •Known catecholamine imbalance or medication use which influences catecholamine levels.
- •History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis).
- •Recent history or acute disease or unstable medical condition.
- •Surgery planned during the course of the trial.
- •A known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence.
研究组 & 干预措施
Placebo Group
Placebo Comparator
Subjects will receive placebo for 28 days
干预措施: Placebo (Drug)
Kava Group
Experimental
Subjects will receive Kavalactones for 28 days
干预措施: Kavalactones (Dietary Supplement)
结局指标
主要结局
Changes in Cortisol
时间窗: Baseline, 4 weeks
Blood serum cortisol levels reported in micrograms per deciliter (mcg/dL)
次要结局
- Change in burnout(Baseline, 4 weeks)
- Change in sleep(Baseline, 4 weeks)
- Change in quality of life(Baseline, 4 weeks)
- Change in cognition(Baseline, 4 weeks)
- Change in motivation(Baseline, 4 weeks)
- Adverse events(4 weeks)
- Change in mood(Baseline, 4 weeks)
- Change in stress(Baseline, 4 weeks)
研究者
Brent A. Bauer
Principal Investigator
Mayo Clinic
研究点 (2)
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