A 12 Week Open Label Trial, Assessing the Effects of Temulawak extract on Genetic Expression in Adult Male Volunteers
- Conditions
- General wellnessAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12616001426471
- Lead Sponsor
- SFI Research Pty Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 32
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method