A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Hypoglycemic Efficacy of Greenyn Momordica Charantia Extracts in Diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fasting glucose
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the inclusion criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Major enrollment criteria include: (1)Subjects have confirmed type 2 diabetes and fail to reach the treatment goal (fasting glucose 140-270mg/dL and hemoglobin A1c (HbA1c) 7-10%) after stable use of 1-3 oral hypoglycemic drugs for 3 months; (2)Subjects have stable diabetes mellitus (DM) history with fasting glucose 140-270mg/dL and HbA1c 7-10% and refuse to use oral medications. Efficacy outcomes include the changes in fasting glucose, Hb1Ac, and insulin sensitivity, and safety assessments include liver and kidney function, and complains made by subjects after the initiation of the investigational products (IP).
详细描述
This study aims to investigate the hypoglycemic efficacy of oral Momordica Charantia extracts containing mcIRBP manufactured by Greenyn Biotechnology. The study objectives include:
- To evaluate the changes in fasting glucose, hemoglobin A1c (Hb1Ac), glucose tolerance test, and insulin sensitivity after taking the investigational products (IP) orally for 3 months.
- To evaluate the safety of the IP, including the liver and kidney function, and complains made by subjects after the initiation of the IP.
This is a randomized, double-blind, placebo-controlled, add-on clinical trial to evaluate the efficacy and safety of Momordica Charantia extracts taken orally for 3 months by subjects with type 2 diabetes. A total of 40 subjects who meet the enrollment criteria and give written consent will be randomly assigned to (A) Momordica charantia extracts group (600mg/day), or (B) Placebo group (Starch 600mg/day) with 20 subjects for each group. Subjects will take the IP for 12 weeks and the hypoglycemic medications taken by the subjects before enrollment will remain stable over the study period.
Study procedures for each visit:
Visit 1: Day 0
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 to 80 years of age
- •Newly diagnosis with type 2 diabetes based on a fasting plasma glucose(FPG)>=126 mg/dL or 2-5 postprandial glucose levels during 75-g OGTT>=200 mg/dL
- •The person who take 1-3 or more medicine to treat hyperglycemic but not very effective.(Fasting glucose:140-270mg/dL，HbA1c 7-10%)
排除标准
- •Serum creatinine > 1.8mg/dL
- •Serum ALT, AST, total bilirubin or alkaline phosphatase higher than 2.5 times of the upper normal range
- •Anemia (Hb Male: < 11g/dL;Female: < 10g/dL)
- •Pregnancy or Lactation
- •Severe angina
- •Moderate-severe heart failure with left ventricular hypertrophy
- •BMI<18 or >38
- •a body weight variation more than 10% during the screening period.
- •Dietary habits change in one months or body weight change >10%
- •Life expectancy is low than 6 months
- •be allergy to bitter melon
- •Severe long-term diabetic complications such as diabetic retinopathy,diabetic neuropathy,systemic orthostatic hypotension,urinary retention,foot ulcers or gastric stasis
- •Acute disease
- •Participation in another clinical trial within 30 days of screening
研究组 & 干预措施
Momordica charantia
Subjects will take the capsule of Greenyn Momordica charantia extracts 600 mg/day orally for three months.
干预措施: Greenyn Momordica charantia extracts (Dietary Supplement)
Placebo control
Subjects will take the capsule of Placebo 600 mg/day orally for three months.
干预措施: Placebo control (Dietary Supplement)
结局指标
主要结局
Fasting glucose
时间窗: from baseline at 3 month
Fasting glucose in milligram per deciliter
Glycated hemoglobin
时间窗: from baseline at 3 month
Glycated hemoglobin in percentage
Fasting insulin
时间窗: from baseline at 3 month
Fasting insulin in milliunit per milliliter
Oral Glucose Tolerance Test
时间窗: from baseline at 3 month
Oral Glucose Tolerance Test in milligram per deciliter
次要结局
- Total cholesterol(from baseline at 3 month)
- Body mass index(BMI)(from baseline at 3 month)
- Hemoglobin(Hb)(from baseline at 3 month)
- Hip circumference(from baseline at 3 month)
- Ketone body(from baseline at 3 month)
- Alanine Aminotransferase (ALT)(from baseline at 3 month)
- Waist circumference(from baseline at 3 month)
- total protein(from baseline at 3 month)
- Blood pressure(from baseline at 3 month)
- Creatinine(from baseline at 3 month)
- Blood urea nitrogen (BUN)(from baseline at 3 month)
- H.D.L.cholesterol(from baseline at 3 month)
- Body fat(from baseline at 3 month)
- Uric Acid(UA)(from baseline at 3 month)
- L.D.L.cholesterol(from baseline at 3 month)
- Upper arm circumference(from baseline at 3 month)
- Aspartate Aminotransferase (AST)(from baseline at 3 month)
研究者
Nae-Cherng Yang
Associate Professor
Chung Shan Medical University