NCT02866539已完成不适用
A Polyherbal for Control of Blood Sugar in Subjects With Impaired Glucose Tolerance and/or Early Type 2 Diabetes. A Randomized Placebo Controlled Study of a Polyherbal (Whole Herb Formulation)
Composite Interceptive Med Science1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Number of diabetes subjects achieving glycemic control
研究概览
简要总结
The aim of the study is to control blood sugar with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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) and a diabetes and a meeting one of the following criteria
- •Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
- •2-h Post load Glucose ≥140 mg/dL during an Oral Glucose Tolerance Test (OGTT). The test should be performed as described by the World Health Organisation(WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR
- •Glycosylated haemoglobin (A1C) ≥5.7%. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized. OR
- •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
- •History of diabetes onset >12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
- •Any history suggestive of micro vascular or macro vascular disease
- •Women in childbearing age unable to practice any form of contraception
- •Impaired renal function; estimated glomerular filtration rate(eGFR) <60mls/min/1.73m
- •Known history of any chronic illness taking regular pharmacological agents.
- •Blood pressure fluctuations exceeding 10 mmHg 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
- •Current or former employees of organic India
- •Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- •Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
研究组 & 干预措施
Polyherbal capsule
Active Comparator
Polyherbal capsule contains leaves of 3 herbs namely C. indica, B. spectabilis and C. rosea.
干预措施: Polyherbal capsule coccinia, bougainvillea, catharanthus (Drug)
Placebo
Placebo Comparator
Placebo will contain an inert substance
干预措施: Placebo (Drug)
结局指标
主要结局
Number of diabetes subjects achieving glycemic control
时间窗: 6 months
a 0.5% reduction in baseline A1c and/or fasting plasma glucose below 125 mg/dl or 2 hour postprandial glucose \<180 mg/dl
Number of pre-diabetes achieving euglycemic status
时间窗: 6 months
measured as A1c \< 5.7% and/or fasting plasma glucose \<100mg/dl/
次要结局
未报告次要终点
研究者
研究点 (1)
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