Herbal Tea for a Control of Blood Sugar in Subjects With Early Type 2 Diabetes: A Pilot Randomized Placebo Controlled Crossover Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Oral Glucose Tolerance Test (OGTT)
研究概览
简要总结
Diabetes mellitus is a chronic disease caused by inherited and/or acquired deficiency in production of insulin by the pancreas, or by the ineffectiveness of the insulin produced. It has become a major healthcare problem in India. High-quality, low-cost solutions adapted to the local context are critical to addressing the current crisis in the management of diabetes. Herbal tea consists of tulsi, guava and stevia, which has glucose lowering properties.The aim of this trial is to study the effect of a herbal tea in the glycemic response in the early type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double blinded study
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
- •Adults aged over 18 years and having a diagnosis of diabetes and meeting one of the following criteria
- •Fasting Plasma Glucose ≥126 mg/dL, fasting defined as no caloric intake for at least 8 hours, AND
- •2-h Post load Glucose ≥140 mg/dL during an OGTT. AND
- •Glycosylated haemoglobin (A1C) ≥ 6.5 %.
排除标准
- •Any one of the following
- •Patients on Insulin therapy.
- •Patients on oral hypoglycemic agents other than metformin
- •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 Anaemia (Hemoglobin <11 g/dl in Female and <13 g/dl in Male)
- •Impaired renal function; estimated glomerular function <60mls/min/1.73m
- •Known history of any chronic illness taking regular pharmacological agents.
- •Blood pressure fluctuations exceeding 20 mmHg 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
- •Known history of autonomic dysfunction like diabetic autonomic neural imbalance or neuropathy
- •Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
研究组 & 干预措施
Active Herbal tea
One tea bag infusion three times a day each before breakfast, lunch and dinner.
干预措施: Herbal Tea (Drug)
Placebo Tea
Similar looking tea bag infusion three times a day each before breakfast, lunch and dinner.
干预措施: Placebo Tea (Drug)
结局指标
主要结局
Oral Glucose Tolerance Test (OGTT)
时间窗: 2 days and 5 days
Change from baseline in OGTT
Fasting Plasma Glucose (FPG)
时间窗: 2 days and 5 days
Change from baseline in Fasting plasma glucose
Number of Subject with adverse events
时间窗: 2 days and 5 days
Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.
次要结局
- Flash Glucose Measurements(2 days and 5 days)