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Trial registered on ANZCTR


Registration number
ACTRN12621001228875
Ethics application status
Approved
Date submitted
4/08/2021
Date registered
13/09/2021
Date last updated
13/09/2021
Date data sharing statement initially provided
13/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Safety Trial for a Traditional Chinese Medicine Herbal Formula
Scientific title
A Phase I Safety Trial for a Traditional Chinese Medicine Herbal Formula in Healthy Adults
Secondary ID [1] 304627 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dizziness 322557 0
Vertigo 323304 0
Condition category
Condition code
Alternative and Complementary Medicine 320179 320179 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A specific Traditional Chinese Medicine (TCM) Herbal Formula consisting of: Alisma orientale rhizome ext. dry 20:1 (12,500 mg), Atractylodes macrocephala root ext. dry 20:1 (5,000 mg), Prunus armeniaca (Semen armeniacae amarum) seed ext. dry 10:1 (1,500 mg), and Cyperus rotundus rhizome ext. dry 10:1 (1,500 mg) per capsule. The dose will be either 1 capsule daily (n=10) or 2 capsules daily (n=10) administered orally for 30 days.
Monitoring of the capsules will be conducted by a participant diary and capsule return at 4 weeks.
Intervention code [1] 320978 0
Treatment: Other
Comparator / control treatment
None
Control group
Dose comparison

Outcomes
Primary outcome [1] 328062 0
Safety via adverse events listed on participant diary and source documents
Timepoint [1] 328062 0
30 days post commencement of the intervention
Secondary outcome [1] 397400 0
Tolerability via the number of side effects will be assessed weekly via the participant diary. The diary provides 15 possible side effect options previously associated with the herbs in the formula (bloating, diarrhoea, dizziness, headache, indigestion, stomach pain, joint pain, loss of appetite, light headedness, nausea, oedema/swelling, increased bruising, low blood pressure, stomach-ache, vomiting) as well as an “other – please provide further details” option. For each symptom experienced the participant will be asked to indicate the date of onset and the date the symptom ended, as well as symptom severity (mild, moderate, severe), perceived relationship to the study drug (definitely related, possibly related, not related), and action taken by the participant regarding the study product (none, discontinued permanently, discontinued temporarily, reduced dose, increased dose, delayed dose).
Timepoint [1] 397400 0
Assessed weekly then collected 30 days post commencement of the intervention
Secondary outcome [2] 397401 0
Quality of life via the quality of life measure SF-36
Timepoint [2] 397401 0
30 days post commencement of the intervention
Secondary outcome [3] 397402 0
Dosing efficacy via the SF-36
Timepoint [3] 397402 0
30 days post commencement of the intervention
Secondary outcome [4] 399244 0
Safety via liver function tests from a blood sample
Timepoint [4] 399244 0
30 days post commencement of the intervention
Secondary outcome [5] 399245 0
Safety via kidney function from a blood sample
Timepoint [5] 399245 0
30 days post commencement of the intervention
Secondary outcome [6] 400817 0
Tolerability via the severity of side effects will be assessed weekly via the participant diary. For each symptom experienced the participant will be asked to indicate the date of onset and the date the symptom ended, as well as symptom severity (mild, moderate, severe), perceived relationship to the study drug (definitely related, possibly related, not related), and action taken by the participant regarding the study product (none, discontinued permanently, discontinued temporarily, reduced dose, increased dose, delayed dose).
Timepoint [6] 400817 0
Assessed weekly, collected 30 days post commencement of the intervention

Eligibility
Key inclusion criteria
Healthy
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or breast-feeding women
2. Anyone with an acute disease
3. History of an un-managed chronic disease
4. Do not speak English
5. Severe mental illness or difficulty communicating
6. Current alcoholism or recreational drug use
7. Anyone taking diabetic medication
8. Bleeding disorders
9. Anyone with stomach ulcer(s)
10. Anyone who gets migraines from physical injury
11. People with dry cracked lips

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer-generated, without block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
This is a safety study, therefore, a sample size of 20 participants, 10 in each group, was considered sufficient.
All data will be exported into SPSS 27.0. Analyses will be conducted on completion of trial. Descriptive statistics will summarise the data as either means and standard deviations or medians with interquartile range depending on the data distribution, and as absolute or relative frequencies. The outcomes will be assessed via paired t-tests for continuous data, and Chi square analysis for binary measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 34547 0
4225 - Bilinga
Recruitment postcode(s) [2] 34565 0
4217 - Gold Coast
Recruitment postcode(s) [3] 34566 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 308988 0
Commercial sector/Industry
Name [1] 308988 0
Ginseng Chinese Medicine Pty Ltd
Address [1] 308988 0
Shop 9B, the Concourse, 409 Victoria Ave, Chatswood, NSW, 2067
Country [1] 308988 0
Australia
Funding source category [2] 309032 0
Government body
Name [2] 309032 0
NSW Government Treasury Department
Address [2] 309032 0
NSW Government Treasury Department
52 Martin Place
Sydney NSW 2000
Country [2] 309032 0
Australia
Primary sponsor type
University
Name
Southern Cross University, National Centre for Naturopathic Medicine
Address
Military Rd, East Lismore, NSW, 2480
Country
Australia
Secondary sponsor category [1] 310008 0
None
Name [1] 310008 0
Address [1] 310008 0
Country [1] 310008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308880 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 308880 0
Southern Cross University, Military Rd, East Lismore, NSW, 2480
Ethics committee country [1] 308880 0
Australia
Date submitted for ethics approval [1] 308880 0
07/06/2021
Approval date [1] 308880 0
09/08/2021
Ethics approval number [1] 308880 0
2021/103

Summary
Brief summary
The purpose of this phase I open-label safety trial is to assess the safety of a traditional Chinese medicine (TCM) herbal formula, containing Alisma orientale, Prunus armeniaca, Cyperus rotundus and Atractylodes macrocephala, in healthy adults aged 18-60 years old. Twenty participants will be recruited, 10 will receive 1 capsule per day, 10 will receive 2 capsules per day for a 30 day period. We hypothesize that the TCM herbal formula is safe and will not cause serious side effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112198 0
Dr Janet Schloss
Address 112198 0
Southern Cross University, National Centre for Naturopathic Medicine, Military Rd, East Lismore, NSW, 2480.
Country 112198 0
Australia
Phone 112198 0
+6142 8896 883
Fax 112198 0
Email 112198 0
janet.schloss@scu.edu.au
Contact person for public queries
Name 112199 0
Dr Janet Schloss
Address 112199 0
Southern Cross University, National Centre for Naturopathic Medicine, Military Rd, East Lismore, NSW, 2480.
Country 112199 0
Australia
Phone 112199 0
+6142 8896 883
Fax 112199 0
Email 112199 0
janet.schloss@scu.edu.au
Contact person for scientific queries
Name 112200 0
Dr Janet Schloss
Address 112200 0
Southern Cross University, National Centre for Naturopathic Medicine, Military Rd, East Lismore, NSW, 2480.
Country 112200 0
Australia
Phone 112200 0
+6142 8896 883
Fax 112200 0
Email 112200 0
janet.schloss@scu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Files for statistical analysis will be de-identified using the participant code and will be kept on password protected drives on SCU computers, accessible to those involved in the clinical trial only. Once the database is locked, only the CI and PI will have access to the data for analysis. Information about the trial participants will be kept confidential and managed according to the requirements of the Australian standards of Good Clinical Practice.
What supporting documents are/will be available?
No other documents available
Summary results
No Results