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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 4
- 主要终点
- 2.PPBG: 140 - 199 mg/dL or 30% reduction from baseline
研究概览
简要总结
Study Design A Double Blind, Prospective, Randomised, Comparative, Placebo Controlled, Two Arm Clinical Study Study Population Adult subjects between 30 and 65 years (both ages and all sexes inclusive) with history of diabetes mellitus type II with or without dyslipidemia. Indication Diabetes Mellitus Type II with or without dyslipidemia
Investigational Product Test : Nichi Glucan
Comparator : Placebo
Dose/Dosage/ROA : 0.5 grams to be consumed thrice day, 30 minutes after breakfast, lunch and dinner. Dissolve the contents of the sachet in half a glass of water, stir well and consume. Treatment Duration 3 months (90 days) Number of subjects 222 subjects. Treatment Arm I : Nichi Glucan : 148 Subjects Treatment Arm II: Placebo : 74 Subjects Assessments for Diabetes mellitus type II 1. Fasting Blood Glucose 2. Post Prandial Blood Glucose (2 hours post meal) 3. HbA1C 4. Post Prandial Spike (1 hour post meal) 5. Quality of Life Questionnaire Assessments for Dyslipidemia (analysed as cohort) 1. Triglycerides 2. Total Cholesterol 3. LDL 4. VLDL 5. HDL
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 Total cholesterol ≥ 250 mg/dL VLDL level of ≥ 40 mg/dL LDL levels of ≥129 mg/dL 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.
结局指标
主要结局
2.PPBG: 140 - 199 mg/dL or 30% reduction from baseline
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
3.HbA1C: 5.7 - 6.4%
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
4.LDL : 100mg/dL or 30% reduction from baseline value
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
5.HDL: ≥45 mg/dL or 30% reduction from baseline value
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
1.FBG: 70 - 125 mg/dL
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
4.HbA1C: 5.7%
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
1.Triglycerides : 150mg/dL or 30% reduction from baseline
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
3.VLDL level 30 mg/dL or or 30% reduction from baseline value
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
2.Total Cholesterol: 200mg/dL or 30% reduction from baseline
时间窗: 1.FBG: Day 1, 45, 90 | 2.PPBG: Day 1, 45, 90 | 3.HbA1C: Day 1, 45, 90 | 1.Triglycerides : Day 1, 45, 90 | 2.Total Cholesterol: Day 1, 45, 90 | 3.VLDL level Day 1, 45, 90 | 4.LDL : Day 1, 45, 90 | 5.HDL: Day 1, 45, 90
次要结局
- 1.Post Prandial Spike (1 hour post meal): 30% reduction from baseline value by end of study.(2.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Total Score of ≤49 by end of study)