CTRI/2018/03/012414已完成未知
A Randomized, Single Centre, Double-Blind, Parallel-group, Placebo Controlled, Two Arm, Comparative, Interventional Study of Salacia in Obese or Overweight, Hyper-lipidemic and Pre-diabetic Adults.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Men and non pregnant women of 18-65 (inclusive of both) years of age
- •Be willing to follow the scheduled visit appointments
- •Willing to provide the written informed consent for participation in the study
- •Body Mass Index (BMI) of 30.0 kg/m2 or above
- •Body Mass Index (BMI) of 28.0 kg/m2 or above in the presence of co-morbidities of treated or untreated dyslipidemia and/or hypertension
- •Stable body weight for a period of past 3 months prior to screening
- •Pre diabetic status: a HbA1C level of 5.7 to 6.4 percent; an Fasting Plasma Glucose (FPG) test result of 100â??125 mg/dL, indicating impaired fasting glucose (IFG) level; or a 2-hour Oral Glucose Tolerance Test (OGTT) result of 140â??199 mg/dL, indicating Impaired Glucose Tolerance (IGT).
排除标准
- •Known type 1 or type 2 diabetes as confirmed by glycosylated haemoglobin of 6.5 percentage or above
- •FPG of 126 mg/dL 7 mmol/L or above
- •2 hour post-challenge (OGTT) plasma glucose of 200 mg/dL 11.1 mmol/L or above
- •Screening calcitonin of 50 ng/L or above; family or personal history of multiple endocrine neoplasia type 2
- •Past history of non-familial medullary thyroid carcinoma or Familial Medullary Thyroid Carcinoma or history of acute/chronic pancreatitis
- •Drug induced obesity
- •Use of approved weight lowering pharmacotherapy
- •Previous surgical treatment of obesity
- •History of major depressive disorder or suicide attempt
- •Uncontrolled hypertension systolic blood pressure of 160 mmHg or above and/or diastolic blood pressure of 100 mmHg or above
- •Participation in any research involving an investigational product within a period of one month prior to screening
- •Subjects unable to adhere to a regular follow up schedule
- •History of any known hypersensitivity or allergy of any sort such as asthma, eczema, atopy or drug allergy etc that would place the subject at increased risk, as determined by the investigator
- •History of chronic alcohol, smoking, chemical, drug abuse or dependence
- •History or presence of clinically significant systemic disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, autoimmune, immunodeficiency e.g., human immunodeficiency virus [HIV] infection, or nervous system or psychiatric disease or other conditions that may interfere with the study or would place the subject at increased risk, as determined by the investigator
- •Pregnant breast feeding mothers and women planning to become pregnant
研究者
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