Efficacy of ActiPhen™ on gastrointestinal tract function in otherwise healthy adults. A randomised double blind placebo-controlled study.

RDC Global Pty Ltd0 个研究点目标入组 69 人开始时间: 2018年5月23日最近更新: 2023年9月4日

适应症

试验速览

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•Males and females aged over 18 years
•- Females using a prescribed form of birth control (e.g. oral contraceptive)
•- Experiencing three or more of the following symptoms of gastrointestinal discomfort including bloating, flatulence, diarrhoea, constipation, reflux, heart burn, abdominal pain/discomfort experienced at least 3 days in the last month
•- Normal dietary habits (no FODMAP diet, elimination diet, vegan diet, etc) with a minimum 2 month period of self-reported dietary stability.
•- Agree to not change current diet or exercise regime during entire study period
•- Agree to not use any other dietary supplements or digestive enzymes during the study period
•- Able to provide informed consent

•- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland
•function Malignancy)
•- People with a past or current history of inflammatory bowel disease or gastrointestinal tract
•- Pregnant or breastfeeding mothers
•- Malignancy or treatment for malignancy within the previous 2 years
•- Receiving/ prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other
•anticoagulation therapy including low dose aspirin
•- Active smokers, nicotine, alcohol, drug abuse
•- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
•- Allergic to any of the ingredients in active or placebo formula
•- Any history of kiwi fruit allergy
•- Those suffering from insomnia or have night-shift employment and unable to have a normal
•night’s sleep
•- People suffering any neurological disorders such as MS
•- Any condition which in the opinion of the investigator makes the participant unsuitable for
•inclusion (including hypercholesterolemia)
•- Participants who have participated in any other clinical trial during the past 3 months
•- Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
•- History of infection in the month prior to the study or taking antibiotic therapy
•- Hydration therapy during study period

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