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Trial registered on ANZCTR


Registration number
ACTRN12616001426471
Ethics application status
Approved
Date submitted
30/09/2016
Date registered
13/10/2016
Date last updated
3/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A 12 Week Open Label Trial, Assessing the Effects of Temulawak extract on Genetic Expression in Adult Male Volunteers
Scientific title
A 12 Week Open Label Trial, Assessing the Effects of Temulawak extract on Genetic Expression in overweight/obese Adult Male Volunteers
Secondary ID [1] 290244 0
Nil known
Universal Trial Number (UTN)
U1111-1188-1485
Trial acronym
SFIR-GENxAU01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
General wellness 300452 0
Condition category
Condition code
Alternative and Complementary Medicine 300308 300308 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
5x 1000mg Temulawak oral tablets standardised to 750mg curcuminoids once daily for 16 weeks.
Adherence will be assessed at each visit by return of containers and review of a memory aid. Subjects will also receive a weekly follow-up phone call to check compliance with taking study medication
Intervention code [1] 296031 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299780 0
mRNA in peripheral blood
Timepoint [1] 299780 0
Timepoint: Baseline, and at day 1, 43 and 84 after intervention commencement
Secondary outcome [1] 328100 0
To evaluate safety parameters of the active compound:
Haematology - Complete blood count: platelet count, RBC Count, RBC Indices (MCV, MCH), WBC Count (absolute), WBC Differential (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocyte count, Haemoglobin, Haematocrit, PFA-200 (at Day 1 prior to dosing and Day 7 visits only).
Clinical Chemistry - BUN, Creatinine, Sodium, CPK, Potassium, Chloride, Total CO2, Calcium, AST (SGOT), ALT (SGPT), GCT, Alkaline phosphatase, Total and direct Bilirubin, Uric Acid, Albumin, Total Protein.
Vital Signs - heart rate and blood pressure. Electrocardiogram (ECG) - 12-lead ECGs (PR, QRS, QT, and QTc intervals).
Timepoint [1] 328100 0
Timepoint: Baseline, and at day 1, 7, 43 and 84 after intervention commencement.

Eligibility
Key inclusion criteria
1. Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, clinical laboratory test results and ECG. Subjects who have abnormal safety laboratory test results outside of the local laboratory normal reference will be excluded from the study at the PIs discretion. One repeat test will be allowed for all out of range results.
2. Males 18-45 years of age
3. BMI between 25-35
4. Non-smoker/Light Smoker (less than 5 cigarettes per day).
5. Agree to abstain from alcohol 24 hours prior to each study visit.
6. Agree to all visits and procedures for the duration of the study
7. Agree to not include any turmeric in their diet for the 12 weeks study duration
8. Agree to avoid consuming spicy foods in their diet for a 3 day period before each visit
9. Agree not to take any dietary supplements, herbal medicines (including, but not limited to, Protein powder blends, St John’s Wort, Turmeric, Curcumin, Silymarin) vitamins, mineral, prescription and/or non-prescription drugs or medicines (including anti-inflammatory drugs) for the duration of the study. Exceptions are allowed for paracetamol as long it is noted in as a concomitant medication. Pure protein powder (e.g. 100% whey) supplements are allowed
10. Provide Informed Consent
11. Agree to use adequate birth control (barrier method of birth control or abstinence) prior to study entry and during the trial and agrees not to donate sperm, for the duration of the study
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History or current diagnosis of substance abuse that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements
2. History or current diagnosis of a significant psychiatric disorder that would, in the opinion of the investigator, affect the subject’s ability to comply with the study requirements
3. Signs and symptoms of chronic and/or acute inflammation and/or infection
4. Positive result for the presence of Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), or human immunodeficiency virus (HIV) antibodies.
5. A positive drug/alcohol screen
6. Has a history of alcohol and/or drug abuse < 12 months from Screening
7. History of current diagnosis of any bleeding disorders
8. Consumption of more than three units of alcohol in any 24 hour period for the duration of the trial (1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol)
9. Participation in a clinical trial or has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
10. BMI > 35
11. BMI < 25
12. Current use (within the past 4 weeks) of dietary supplements, protein powder blends, herbal medicines (including St John’s Wort, Turmeric, Curcumin, Silymarin) vitamins, minerals, prescription and/or non-prescription drugs or medicines (including anti-inflammatory drugs). Otherwise potentially eligible participants, who are not consuming curcumin products, and are willing to stop current use, can be re-screened for eligibility after a 2 week washout period.
13. Use of anti-inflammatory medications (>2 weeks, within the past 12 weeks)
14. Subject has donated blood or plasma or clinically significant blood loss within 60 days to the screening visit
15. History of migraine.
16. Unwillingness or inability to follow the procedures outlined in the protocol.
17. Vegetarian, vegan, or other significant dietary restriction and who do not agree to consume any of the standardized food.
18. Subjects with known hypersensitivity to the active substance or any of the excipients
19. Any other condition is present that in the opinion of the investigator might jeopardize the patient's safety or ability to comply with requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 294612 0
Commercial sector/Industry
Name [1] 294612 0
SFI Research Pty Ltd.
Address [1] 294612 0
Level 4, 156 Pacific Highway, St Leonards, NSW 2065
Country [1] 294612 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SFI Research Pty Ltd.
Address
Level 4, 156 Pacific Highway, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 293475 0
None
Name [1] 293475 0
Address [1] 293475 0
Country [1] 293475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296053 0
QIMR Berghofer HREC
Ethics committee address [1] 296053 0
300 Herston Rd, Herston, Queensland 4006
Ethics committee country [1] 296053 0
Australia
Date submitted for ethics approval [1] 296053 0
15/08/2016
Approval date [1] 296053 0
26/08/2016
Ethics approval number [1] 296053 0
P2249

Summary
Brief summary
This study will be an open-label, 12 week, clinical trial in males aged 18 to 45 with the aim:
To compare genetic expression patterns after 12 weeks treatment of temulawak extract in male adults.
To evaluate safety parameters of the active compound.
A total of 32 participants will be enrolled into the study in order to allow for 24 participants to complete the study. Participants will be asked to attend the clinic at Screening, Day 1 (Visit 1), Day 7 (Visit 2), Day 40 (visit 3) and Day 81 (visit 4) the end of study visit. The study will last approximately 4 months in total for each participant from screening to last visit. Participants will need to attend the clinical unit 5 times for around three hours at each visit.

Trial website
http://www.supportastudy.com.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69370 0
Dr Alexandra Uren
Address 69370 0
Q-Pharm Pty Ltd
Level 5, 300C Herston Road
Herston, Queensland 4006 Australia
Country 69370 0
Australia
Phone 69370 0
+61 7 3845 3636
Fax 69370 0
Email 69370 0
A.Uren@qpharm.com.au
Contact person for public queries
Name 69371 0
Mrs Alice Lau
Address 69371 0
PO Box 78, Royal Brisbane and Womens Hospital, Herston, QLD 4029 Australia
Country 69371 0
Australia
Phone 69371 0
+61738453657
Fax 69371 0
Email 69371 0
a.lau@qpharm.com.au
Contact person for scientific queries
Name 69372 0
Dr Alexandra Uren
Address 69372 0
Q-Pharm Pty Ltd
Level 5, 300C Herston Road
Herston, Queensland 4006 Australia
Country 69372 0
Australia
Phone 69372 0
+61 7 3845 3636
Fax 69372 0
Email 69372 0
A.Uren@qpharm.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary