A Poly herbal for Control of Blood Sugar in Subjects With Impaired Glucose Toleranceand/or Early Type 2 Diabetes. A Randomized Placebo Controlled Study of a Poly herbal(Whole Herb Formulation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The primary objective at 6 months is as follows
研究概览
简要总结
The aim of study is to control blood glucose in impaired glucose tolerance and early type 2 diabetes using combination of 3 whole herbs Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 30.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males and non-pregnant females aged ≥30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria 1.Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR 2.2-h Post load Glucose ≥140 mg/dL during an OGTT.
- •The test should be performed as described by the WHO, using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water.
- •OR 3.Glycosylated haemoglobin (A1C) ≥5.7%.
- •The test should be performed in a laboratory using a method that is NABL certified and standardized.
- •OR 4.In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months.
排除标准
- •Any one of the following 1.History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin) or Insulin.
- •2.Any history suggestive of micro vascular or macro vascular disease 3.Women in child bearing age unable to practice any form of contraception 4.Impaired renal function; eGFR<60mls/min/1.73m
- •5.Known history of any chronic illness taking regular pharmacological agents.
- •6.Blood pressure fluctuations exceeding 10mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 2 or more antihypertensive medications regularly in the last 6 weeks 7.Current or former employees of organic India 8.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- •9.Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
结局指标
主要结局
The primary objective at 6 months is as follows
时间窗: The primary objective at 6 months is as follows | 1.In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl | 2.In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/
2.In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/
时间窗: The primary objective at 6 months is as follows | 1.In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl | 2.In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/
1.In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl
时间窗: The primary objective at 6 months is as follows | 1.In patients with diabetes; a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose 180 mg/dl | 2.In those with pre-diabetes it will be achieving eugylcemic status measured as A1c 5.7% and/or fasting plasma glucose 100 mg/dl/
次要结局
- Number of diabetes patients with hypoglycemia as adverse events(1 months)