Short Term Cardiovascular Effects of Zingiber Officinale as add-on Therapy in a Population of Type 2 Diabetes Individuals
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Variation of mitral E' velocity
研究概览
简要总结
The aim of the study was the evaluation of cardiovascular benefits of Zingiber officinale Roscoe in patients with type 2 diabetes mellitus before and after 6 weeks of add-on therapy.
详细描述
the investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from December 2016 and May 2017.
Intervention consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day, for a period of 6 weeks. Before and after intervention, the following were done by the participants: bioelectrical impedance analysis (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests, kidney function tests and full blood counts. These were followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after intervention.
Clinical evaluation with fasting blood sugar control and blood pressure controls were done at day 21 for safety purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known T2DM patients aged above 21years
- •No change in anti-diabetic medication during the last three months.
- •HbA1c between 42 to 64mmol/mol (6-8%).
排除标准
- •Patient already on ginger supplementation or other herbal medication
- •Drugs that could interact with ginger or whose effects may be amplified such as NSAIDS, corticosteroids and anticoagulants like heparin or warfarin, as far back as 1 month before study.
- •Cardiac, renal disease and liver pathologies
- •Heartburn or peptic ulcer disease
- •Sensitivity, intolerance or allergy to ginger
- •Discontinued intervention
- •Withdrawal of consent
结局指标
主要结局
Variation of mitral E' velocity
时间窗: 6 weeks
The mitral E' velocity is one of the methods for evaluating diastolic function.
次要结局
- Variation of blood pressure.(6 weeks)
- Variation of weight loss(6 weeks)
- Variation of HbA1c(6 weeks)
- Variation of transmitral flow parameters such as E velocity(6 weeks)
- Variation of lipid profile.(6 weeks)
研究者
CN NGANOU-GNINDJIO, MD, MSc
Dr, Principal investigator
Yaounde Central Hospital