ACTRN12621000470897已完成未知
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.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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