CTRI/2022/03/040987已完成未知
A double-blind, randomised, placebo controlled, parallel study to evaluate the efficacy of Slimilyn�® Capsules in weight loss and to evaluate its safety in overweight and obese adult subjects.
Herbalyn Lifesciences Inc0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •a. Adult males and non-pregnant females aged 18 to 60 years.
- •b. Have a BMI of 25.0 kg/m2and above, along with body fat of >25%.
- •c. Stable body weight during the previous 3 months (less than 5 kg self-reported weight change)
- •d. Not one of the following eating disorders by subjects declaration anorexia nervosa, bulimia nervosa.
- •e. Generally considered healthy according to medical history, physical examination, electrocardiogram (ECG), and laboratory evaluation with a special emphasis on metabolic parameters (fasting glucose concentration < 100 mg, normal blood pressure) as per principal investigatorââ?¬•s judgment.
- •f. Subjects must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- •g. Subjects must sign an informed consent indicating that they are aware of the investigational nature of the study.
排除标准
- •a. Diagnosis of type 1 or type 2 diabetes
- •b. Visit 1 thyroid-stimulating hormone (TSH) outside of the range of 0.4- 4.5
- •c. History of chronic pancreatitis or idiopathic acute pancreatitis and other
- •chronic gastroenterological disease
- •d. Obesity induced by other endocrinologic disorders (e.g., Cushing Syndrome)
- •e. Current or history of treatment with medications that may cause significant
- •weight gain for at least 3 months before this trial
- •f. Current participation in an organized diet reduction program (or within the
- •last 3 months)
- •g. Previous surgical treatment for obesity (excluding liposuction if performed
- •more than one year before trial)
- •h. Subjects on prescription and non-prescription appetite or weight modifying
- •drugs including herbal products
- •i. Used of any investigational drug or device during the study or within 30
- •days prior to 1st dosing of study.
研究者
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