The effects of the herbal preparation, STW5-II on lower oesophageal sphincter function in healthy volunteers.

niversity of Adelaide0 个研究点目标入组 16 人开始时间: 2021年4月23日最近更新: 2023年8月21日

适应症

试验速览

STW5-II had no effects on oesophago-gastric junction pressures or gastrointestinal sensations.

•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.

•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
•- 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)
•- 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 tolerate oro/naso-gastric tube
•- 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)

发起方

niversity of Adelaide