A double-blind placebo-controlled randomised clinical trial assessing the efficacy and safety of a novel herbal formulation for weight loss in an Australian population of healthy adults who are overweight.
- Conditions
- OverweightAlternative and Complementary Medicine - Herbal remedies
- Registration Number
- ACTRN12621000470897
- Lead Sponsor
- Southern Cross University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
1.Adults aged between 18 and 60 years old
2.BMI 25-29.9 kg/m2
3.Willingness to consume the prescribed study diet of approximately 1,500 KCal for women and 2000 KCal for men per day
4.Negative pregnancy test at baseline and 3 months for females of childbearing age, use of reliable contraception throughout the trial
1.Obesity (BMI equal to or greater than 30)
2.Current use of other weight loss medications including stimulants, laxatives or diuretics taken solely for the purpose of weight loss in the last 3 months.
3.Recent unexplained weight loss or gain
4.History of eating disorders
5.History of thyroid, cardiovascular disease or diabetes
6.History of other clinically significant disorders (HIV, hepatitis, pancreatitis, lactic acidosis or hepatomegaly with steatosis)
7.History of motor weakness or peripheral sensory neuropathy
8.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
9.Diagnosis of alcoholism or recreational drug use
10.Severe mental illness or difficulty in communicating
11.History of allergy to spices and herbal products
12.Pregnant or breastfeeding females
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method