An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Simpl†of Essen Fooddies India Pvt. Ltd as a Nutritional Supplement in Adults with Diabetes Mellitus Type II
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Total Score of ≤49 by end of study
研究概览
简要总结
Study Design : Open Label, Prospective, Non-Randomised,Non-Comparative, Single Arm Clinical Study
Indication : Diabetes Mellitus Type II
Investigational Product Details Name : SIMPL Route of Administration : Oral Formulation : Powdered Nutritional Formulation Dose : 40g (4 scoops) in 150ml luke warm water Dosage : OD for 3 months
Subject Population : Adult subjects between 30 and 65 years (both agesand all sexes inclusive) with history of Diabetes Mellitus Type II withoutcomplications
Treatment Arms : One. Non Comparative Single ArmStudy
Number of Subjects : 50 Subjects
Efficacy Assessments: 1. Fasting Blood Glucose : Day 1, Day 90 2. HbA1C : Day 1, Day 90 3. Diabetes Quality of Life Brief Clinical Inventory Questionnaire : Day 1, Day 45, Day 90 4. IP Feedback Questionnaire : Day 90
Safety Assessments: 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Background of the study: Diabetesmellitus is characterized by high blood glucose level with typicalmanifestations of thirst, polyuria, polydipsia, and weight loss. It is causedby defects in insulin-mediated signal pathways, resulting in decreased glucosetransportation from blood into muscle and fat cells. The major risk is vascularinjury leading to heart disease, which is accelerated by increased lipid levelsand hypertension. Oral nutritional supplements can be prescribed to supply one or morenutrient deï¬ciencies and restore the proper development and function of the body. The aim of suchproducts is to supplement everyday diet with nutrients in an effort to elevatethe health status in people with diabetes mellitus type II
Purpose of the Study : Simpl is a nutritional supplement by Essen Fooddies India Pvt. Ltd. withnutrients that are essential to improve the nutritional state of adults,specifically those with Type II Diabetes Mellitus. It helps in reducing bloodsugar levels, improving immunity and heart health.
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 all genders inclusive) 2.Subjects with history of Diabetes Mellitus Type II treated only by oral hypoglycemic agents and/or insulin.
- •3.Subjects who are willing to follow Diabetic friendly diet and exercise (walking) for a minimum of 30 minutes per day.
- •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 with Galactosemia, and any other disorder that limits normal nutritional intake 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 [e.g., 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 are not eligible for enrolment in the study.
结局指标
主要结局
3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Total Score of ≤49 by end of study
时间窗: 1.Fasting Blood Glucose Levels: Day 1, Day 90 | 2.HbA1C : Day 1,Day 90 | 3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Day 1, Day 45, Day 90 | 4.IP Feedback Questionnaire (IPFBQ): Day 90
1.Fasting Blood Glucose Levels: Improvement by 10% from baseline
时间窗: 1.Fasting Blood Glucose Levels: Day 1, Day 90 | 2.HbA1C : Day 1,Day 90 | 3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Day 1, Day 45, Day 90 | 4.IP Feedback Questionnaire (IPFBQ): Day 90
2.HbA1C: Improvement by 10% from baseline
时间窗: 1.Fasting Blood Glucose Levels: Day 1, Day 90 | 2.HbA1C : Day 1,Day 90 | 3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Day 1, Day 45, Day 90 | 4.IP Feedback Questionnaire (IPFBQ): Day 90
4.IP Feedback Questionnaire (IPFBQ): Total Score of ≥20.
时间窗: 1.Fasting Blood Glucose Levels: Day 1, Day 90 | 2.HbA1C : Day 1,Day 90 | 3.Diabetes Quality of Life Brief Clinical Inventory Questionnaire: Day 1, Day 45, Day 90 | 4.IP Feedback Questionnaire (IPFBQ): Day 90
次要结局
未报告次要终点