A Phase I Safety Trial for a Chinese Medicine Herbal Formula.
- Conditions
- DizzinessVertigoAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12623000765628
- Lead Sponsor
- Southern Cross University
- Brief Summary
The Chinese formula was found to be safe at both high and low doses given for 14 days. The side effect profile was low.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
1.Healthy adults aged between 18 and 60 years old
2.BMI is equal or greater than 18.5 and below 35
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method