Control of Glycemic Variability Using a Polyherbal: A Randomized Placebo Controlled Study of Whole Herb Formulations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean amplitude glycemic excursion
研究概览
简要总结
The aim of the study is to get insight into control of glycemic variability 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.
详细描述
The glycemic variability would be obtained at 14 days with the usage of Flash glucose monitoring system manufactured by Abbott and outcomes would be compared at the end of ambulatory glucose profile.
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 —（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 ≥18 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) or diabetes and meeting one of the following criteria
- •Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
- •Glycosylated haemoglobin (A1C) ≥ 6 %. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized within last 3 months.
排除标准
- •Any one of the following
- •Patients on Insulin therapy.
- •Any history suggestive of micro vascular or macro vascular disease - coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.
- •Women in child bearing age unable to practice any form of contraception
- •Patients with diagnosis of Anemia (Hb<11 g/dl in Female and <13 g/dl in Male)
- •Impaired renal function; estimated estimated glomerular filtration rate <60mls/min/1.73m
- •Known history of any chronic illness taking regular pharmacological agents.
- •Blood pressure fluctuations exceeding 20 mm of Hg on 2 subsequent clinic visits or known history of hypo tension or bradycardia in last 6 months or taking 3 or more anti-hypertensive medications regularly in the last 6 weeks
- •Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
- •Current or former employees of organic India or any potential conflict of interest in participation
- •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
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 will contain an inert substance
干预措施: Placebo (Drug)
结局指标
主要结局
Mean amplitude glycemic excursion
时间窗: 14 days
To demonstrate that the difference in mean amplitude glycemic excursions among patients receiving polyherbal medication will be less than 1mmol/dL or 18mg/dL for a sampling frequency: 1 every 15 minutes over 14 days
次要结局
- Mean estimated glycated hemoglobin(14 days)
- Number of hypoglycemia episodes(14 days)