Placebo controlled, double-blind study for efficacy of two herbal supplements (Trigonella foenum-graecum Seed Extract and Coccinia Grandis Extract) for Normalizing Elevated (pre-diabetic) blood Glucose and improving Insulin Sensitivity - a 3 arm study.

Evidence Sciences Pty. Ltd.0 个研究点目标入组 79 人开始时间: 2018年1月12日最近更新: 2022年6月27日

适应症

试验速览

暂无简介。

•Male and females at least 18 years of age at time of entry on study;
•Impaired Fasting blood glucose levels and/or insulin resistance;
•BMI is greater than 25;
•Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;
•Agree to undergo venipuncture on multiple occasions;
•Agree to adhere to the study protocol, including not changing diet or major exercise patterns over the 12 week study period.

•Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including:
•- Physical examination; Clinical chemistry; Haematology; Urinalysis; Vital signs;
•- Diagnosis of Type II Diabetes Mellitus
•- Taking Anti-Obesity medications such as Orlistat
•- Taking oral blood glucose-lowering medications such as Sulfonylureas, Biguanides, Alpha-glucosidase inhibitors, Thiazolidinediones
•- Taking any dietary supplements or herbal medicines specifically for supporting blood sugar including lipoic acid and gymnemia etc.
•- Have recent episodes of symptomatic coronary arterial disease, stroke, and any cardiovascular events including infarction (heart attack)
•- Having treatment for cancers within last 5 years;
•- Taking anti-coagulants such as warfarin;
•- Having any allergies or past reactions to ingredients in treatment and placebo supplements, including fenugreek seeds, cucumber or maltodextrin;
•- Alcohol abuse;
•- The use of any illicit drugs;
•- (Women only) Pregnancy or nursing of an infant; or not taking adequate precautions to prevent pregnancy; or not having had a normal menstrual cycle.
•- Commencing lifestyle interventions such as major dietary changes and increasing exercise duration/intensity;

发起方

Evidence Sciences Pty. Ltd.