A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Two Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Nichi Glucan in the Management of Adult Subjects with Diabetes Mellitus Type II with/without Dyslipidemia.

Enerflo Singapore Pvt Ltd0 个研究点目标入组 157 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 157

研究概览入排标准研究者记录与标识符相似试验

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

•1.Adult subjects between 30 and 65 years (both ages and sexes inclusive)
•2.Subjects with history of Diabetes Mellitus Type II treated only by oral hypoglycaemic agents and/or insulin.
•3.Subjects with Dyslipidemia to be analysed as cohort; having fasting triglyceride levels >=200mg/dL and any one or all of the following
•ï?§Total cholesterol >= 250 mg/dL
•ï?§VLDL level of >= 40 mg/dL
•ï?§LDL levels of >=129 mg/dL
•ï?§HDL level of <= 39 mg/dL
•4.Subjects who are non-alcoholic and non-smokers/non-users of tobacco.
•5.Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period.
•6.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

排除标准

•1.Subjects with allergy, sensitivity or intolerance to the study drugs and their formulation ingredients
•2.Subjects who are HIV Positive.
•3.Subjects on drugs, supplements, therapy regimens intended for the treatment of obesity upto 3 months prior to the date of screening.
•4.Subjects with a history of significant cardiovascular disease (eg, congestive heart failure New York Heart Association Grade III/IV, arrhythmia known to increase the risk of thromboembolic events [eg, atrial fibrillation], coronary artery stent placement, angioplasty, and coronary artery bypass grafting); Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA)
•5.Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
•6.Subjects with complete cancer remission less than 3 years prior to the date of screening.
•7.Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication.
•8.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
•9.Subjects who are on anti-depressants, anti-psychotics.
•10.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
•11.Subjects who have participated in any clinical study within 3 months from the date of enrolment.
•12.Females who are pregnant or lactating or planning to become pregnant during the study period.
•13.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•14.Subjects, who in the opinion of the Investigator/CRMC are not eligible for enrolment in the study.

研究者

发起方

Enerflo Singapore Pvt Ltd

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