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
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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 10 days
研究概览
简要总结
The aim of this study is to gain insight into control of glycemic variability in impaired glucose tolerance and early type 2 diabetes using combination of 3 whole herbs Coccinia indica, Bougainvillea spectabilis and Madagascar periwinkle.
Glycemic variability refers to swings in blood glucose level. It plays important role in the development of diabetic micro- and macrovascular complications, hypoglycemic unawareness and it may be associated with an increased risk of both hypo- and hyperglycemic excursions. We hope to reduce the gylcemic variability with herbal drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
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 1.Fasting Plasma Glucose ≥100 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND 2.Glycosylated haemoglobin (A1C) ≥ 6 %.
- •The test should be performed in a laboratory using a method that is NABL certified and standardized within last 3 months.
排除标准
- •Any one of the following 1.Patients on Insulin therapy.
- •2.Any history suggestive of micro vascular or macro vascular disease – coronary artery disease, stroke, peripheral artery disease or diabetes related retinal changes.
- •3.Women in child bearing age unable to practice any form of contraception 4.Patients with diagnosis of Anemia (Hb<11 g/dl in Female and <13 g/dl in Male) 5.Impaired renal function; eGFR<60mls/min/1.73m
- •6.Known history of any chronic illness taking regular pharmacological agents.
- •7.Blood pressure fluctuations exceeding 20mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 3 or more antihypertensive medications regularly in the last 6 weeks 8.Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy 9.Current or former employees of organic India or any potential conflict of interest in participation 10.Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
- •11.Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
结局指标
主要结局
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 10 days
时间窗: 10 days
次要结局
- Mean estimated glycated hemoglobin difference(10 days)
- Number of hypoglycemia episodes(10 days)