ACTRN12621000204842终止未知
The effects of the herbal preparation, STW5-II, on gastric emptying and intragastric distribution in healthy volunteers.
niversity of Adelaide0 个研究点目标入组 4 人开始时间: 2021年2月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 4
研究概览
简要总结
The study was stopped early due to recruitment difficulties. Statistical analysis was not performed on data obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Healthy, lean (BMI: 19-25 kg/m2) male and female volunteers will be included. Participants will be required to be weight-stable (ie <5% fluctuation) at study entry. Females will be required to be premenopausal and studied during the follicular phase of the menstrual cycle
排除标准
- •Each participant will be questioned prior to the study to exclude:
- •- regular GI symptoms, as measured by the GI symptom score (score >1 for any component), or significant GI disease or surgery
- •- use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, body weight or appetite (eg domperidone, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
- •- regular medication that cannot be discontinued during the study where it may affect outcomes
- •- lactose intolerance/other food allergy, or allergy to any of the ingredients of STW5-II
- •- current gallbladder or pancreatic disease
- •- cardiovascular or respiratory diseases
- •- epilepsy
- •- any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
- •- Exposure to ionising radiation from X-ray machines or radioactive substances in the last 12 months for research purposes
- •- high performance athletes
- •- current intake of > 2 standard drinks on > 5 days per week
- •- current smokers/users of tobacco products (including pipe, chewing, cigarettes, cigars, sheesha, vaping)
- •- recreational drug use (e.g marijuana)
- •- current intake of any illicit substance
- •- vegetarians
- •- inability to comprehend study protocol
- •- in female participants, pregnancy, lactation or surgical sterilisation (a pregnancy test will be performed, using a urine sample, prior to each study day)
研究者
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