A Phase I Safety Trial examining doses for a Chinese Medicine Herbal Formula.

Southern Cross University0 个研究点目标入组 20 人开始时间: 2023年7月13日最近更新: 2023年11月27日

试验速览

The Chinese formula was found to be safe at both high and low doses given for 14 days. The side effect profile was low.

•1.Pregnant or breast-feeding women or those unwilling to use effective contraception during the trial
•2.Anyone with an acute disease
•3.Weak or emancipated people
•4.Indicators of an unmanaged chronic disease as judged by the health qualified researcher before enrolment.
•5.Unable to speak or understand English or cannot understand the trial
•6.Severe mental illness or difficulty communicating
•7.Current alcoholism ( >14 standard drinks a week) or current recreational drug use
•8.Current use of diabetic medication
•9.A diagnosis of diabetes mellitus (any type)
•10.Current bleeding disorder
•11.Current stomach ulcer(s) or current medication to treat/prevent stomach ulcers
•12.Anyone who experiences migraine, vertigo and/or dizziness from a physical injury or a brain tumour
•13.People with dry cracked lips (from a TCM perspective)
•14.Current use of diuretics (prescription of supplement)
•15.Any condition characterised by severe diarrhoea.
•16.Current severe constipation
•17.Currently experiencing excessive sweating episodes
•18.Current dry cough
•19.Concurrent use of any medication/supplement with a known interaction with any IMP ingredient
•20.Known allergy or intolerance to any of the ingredients in the IMP

发起方