ACTRN12621000149864已完成未知
The effects of the herbal preparation, STW5-II, on proximal gastric relaxation in healthy volunteers.
niversity of Adelaide0 个研究点目标入组 16 人开始时间: 2021年2月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
STW5-II increased proximal gastric volumes in the third hour following administration. Although there were significant treatment effects for nausea and abdominal discomfort, overall symptom scores were low.
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
- 18 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
- •- 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-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)
研究者
相似试验
已完成
不适用
The effects of the herbal preparation, STW5-II on lower oesophageal sphincter function in healthy volunteers.Functional DyspepsiaACTRN12621000480886niversity of Adelaide16
已完成
4 期
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal GasIrritable Bowel SyndromeFunctional DyspepsiaNCT04656730Hospital Vall d'Hebron68
Unknown
不适用
Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital StayAcute Myeloid Leukemia, AdultNCT04240600Hospital General de Mexico74
已完成
不适用
The Effect of Serotonergic Modulation on Intestinal Permeability and Visceral Hypersensitivity in Healthy Individuals and Irritable Bowel Syndrome (IBS) PatientsIrritable Bowel SyndromeNCT00731003Maastricht University Medical Center60
已完成
不适用
Intestines and Liver Contribution to Fasting Postprandial HypertriglyceridemiaMetabolic SyndromeHypertriglyceridemiaNCT02898142Assistance Publique - Hôpitaux de Paris39