A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Efficacy and Safety of PreCrea®, a Twice-daily Dietary Supplement in People With Higher Than Normal Blood Sugar Levels.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Safety of Dietary Supplement PreCrea 600 mg twice-daily
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.
详细描述
A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years to ≤ 65 years
- •Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG >100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment
- •Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures
排除标准
- •Subjects with Type 1 Diabetes Mellitus
- •Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
- •Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
- •Cardiac status New York Heart Association class III-IV
- •Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic
- •Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female
- •Clinically significant peripheral edema
- •Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
- •Participants on steroid
- •Pregnancy or lactating women
- •Known hypersensitivity to any of the study drugs
- •Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
- •Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study.
- •Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.
研究组 & 干预措施
PreCrea
Study dietary supplement (Precrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification program.
干预措施: Study dietary supplement (PreCrea 600 mg capsules) (Dietary Supplement)
Placebo 600 mg capsules
Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Safety of Dietary Supplement PreCrea 600 mg twice-daily
时间窗: Day 1 (Baseline) to Day 90 (End of Study)
Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to end of study (Day 90); Serum Creatinine from baseline (Day 1) to end of study (Day 90)
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels
时间窗: Day 1(Baseline) to Day 90 (End of Study)
Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days
次要结局
- Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)(Day 1 (Baseline) to Day 90 (End of Study))
研究者
Joe Fenn
Sponsor-Medical Director
PreEmptive Meds, Pvt. Ltd