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Trial registered on ANZCTR


Registration number
ACTRN12623000765628
Ethics application status
Approved
Date submitted
22/03/2023
Date registered
13/07/2023
Date last updated
19/11/2023
Date data sharing statement initially provided
13/07/2023
Date results provided
19/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I Safety Trial for a Chinese Medicine Herbal Formula.
Scientific title
A Phase I Safety Trial examining doses for a Chinese Medicine Herbal Formula.
Secondary ID [1] 309580 0
None
Universal Trial Number (UTN)
Trial acronym
SAFECHM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dizziness 329421 0
Vertigo 329422 0
Condition category
Condition code
Alternative and Complementary Medicine 326369 326369 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two capsules twice daily taken 4 hours apart containing Nelumbinis folium(3,000mg), Alismatis Rhizoma (25,000mg), Citri reticulatae Pericarpium (3000mg), Citri reticulatae viride Pericarpium (3,000mg), Atractylodis macrocephalae Rhizoma (10,000mg).
The mode will be an oral capsule taken daily for 15 days and compliance will be monitored by capsule return and a diary.
Intervention code [1] 325701 0
Treatment: Other
Comparator / control treatment
Four capsules twice daily taken 4 hours apart containing Nelumbinis folium(3,000mg), Alismatis Rhizoma (25,000mg), Citri reticulatae Pericarpium (3000mg), Citri reticulatae viride Pericarpium (3,000mg), Atractylodis macrocephalae Rhizoma (10,000mg).
The mode will be an oral capsule taken daily for 15 days and compliance will be monitored by capsule return and a diary.
Control group
Active

Outcomes
Primary outcome [1] 334220 0
To evaluate the safety of a Chinese medicine (CM) Herbal Formula by liver and kidney function, HbA1c, blood glucose and vitamin D3 via blood pathology tests. The side effect profile and the number and severity of serious adverse events will also be monitored. Safety will be considered to not be confirmed if 1 in 10 participants experience serious adverse events from either dose that have a reasonable possible causal relationship to the investigational medical product (IMP).
Timepoint [1] 334220 0
From baseline to 15 days on the active treatment. Blood tests for liver, kidney, blood glucose, and vitamin D3 will be conducted and compared. The adverse events will be checked via a study-specific questionnaire and participant self-reported dairy. A further 15 days on no treatment will be monitored with the same blood tests conducted for safety and adverse events checked via study-specific questionnaire. Therefore 30 days per participant.
Secondary outcome [1] 419877 0
To assess tolerability and safety of a CM Herbal Formula in healthy adults by the number and severity of non-serious adverse events that have a reasonable possible causal relationship to the IMP. This will be monitored by a study specific questionnaire, clinical examination and diary records.
Timepoint [1] 419877 0
Day 15 after taking the active investigational product and day 30 after 15 days not taking the investigational product.
Secondary outcome [2] 419878 0
To assess safety and tolerability of a TCM Herbal Formula in healthy adults via the quality-of-life measure SF-36.
Timepoint [2] 419878 0
On day 15 after taking the investigational product and day 30 after not taking the investigational product for 15 days.

Eligibility
Key inclusion criteria
1. Healthy adults aged between 18 and 60 years old
2. BMI is equal or greater than 18.5 and below 35
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All investigators, researchers and participants will be blinded to the randomisation by allocation involving contacting the holder of the allocation schedule who will be "off-site" or at central administration site.
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
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 primary outcome will be assessed via paired t-tests. The side effects will be assessed by percentage and SF-36 will be assessed via paired t-tests and Chi square analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/07/2023
Actual
24/07/2023
Date of last participant enrolment
Anticipated
22/12/2023
Actual
25/09/2023
Date of last data collection
Anticipated
22/01/2024
Actual
28/09/2023
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24314 0
Southern Cross University Health Clinic - Lismore
Recruitment postcode(s) [1] 39868 0
2480 - Lismore
Recruitment postcode(s) [2] 39869 0
2480 - Lismore Heights
Recruitment postcode(s) [3] 39870 0
2481 - Byron Bay
Recruitment postcode(s) [4] 39871 0
2482 - Mullumbimby
Recruitment postcode(s) [5] 39872 0
2479 - Bangalow
Recruitment postcode(s) [6] 39873 0
2478 - Ballina

Funding & Sponsors
Funding source category [1] 313457 0
Commercial sector/Industry
Name [1] 313457 0
Ginseng Chinese Medicine Pty Ltd
Country [1] 313457 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
1 Military Road, Lismore NSW 2480
Country
Australia
Secondary sponsor category [1] 315228 0
None
Name [1] 315228 0
Address [1] 315228 0
Country [1] 315228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312657 0
Southern Cross University HREC
Ethics committee address [1] 312657 0
Ethics committee country [1] 312657 0
Australia
Date submitted for ethics approval [1] 312657 0
24/04/2023
Approval date [1] 312657 0
03/07/2023
Ethics approval number [1] 312657 0
2023/139

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125450 0
Dr Janet Schloss
Address 125450 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road, Lismore
NSW 2480
Country 125450 0
Australia
Phone 125450 0
+61 436 101 306
Fax 125450 0
Email 125450 0
[email protected]
Contact person for public queries
Name 125451 0
Janet Schloss
Address 125451 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road, Lismore
NSW 2480
Country 125451 0
Australia
Phone 125451 0
+61 2 6625 9255
Fax 125451 0
Email 125451 0
[email protected]
Contact person for scientific queries
Name 125452 0
Janet Schloss
Address 125452 0
National Centre for Naturopathic Medicine
Southern Cross University
1 Military Road, Lismore
NSW 2480
Country 125452 0
Australia
Phone 125452 0
+61 436 101 306
Fax 125452 0
Email 125452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a safety and dosing trial, no individual participant data will be made available. In addition, this particular trial is not for a specific condition yet so no health outcomes are being collected.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.