Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
详细描述
Trigonella foenum-graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of antidiabetic compounds, from its seeds, leaves and extracts in different systems of medicine in asia. Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems. Preliminary animal and human studies suggest possible hypoglycemic and anti-hyperlipidemic properties of fenugreek seed powder taken orally. In a randomized placebo controlled study conducted by Gupta et al showed that two month treatment with the hydro-alcoholic extract of fenugreek seeds improved glycemic control in 12 non-insulin dependent diabetes mellitus patients. In addition, there was improvement in insulin sensitivity and plasma lipid profile. Fenugreek extract was also well tolerated in diabetic patients.
In the proposed study, hydroalcoholic Fenugreek seed extract will used add-on to the existing therapy in patients with type-2 diabetes. The efficacy and safety of the extract will be evaluated using standard methodology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Type-2 Diabetes of less than 10 years duration
- •Patients with HbA1c >7.0%
- •Patients with fasting plasma glucose not exceeding 180 mg/dL
- •Patients with Negative Urine sugar
- •Patients who are on oral hypoglycaemic agents containing either Metformin or Sulfonylurea or both
- •There should not be any change their in anti-diabetic treatment for at least one month
排除标准
- •Patients with diabetes other than type-2 diabetes mellitus
- •Patients with evidence of renal disease (S. Creatinine > 1.5mg/dL)
- •Patients with evidence of liver disease (AST/ALT >3 times of normal
- •Pregnant and lactating mothers and women intending pregnancy
- •Patients who participated in any other clinical trial within the last 30 days
- •Patients with history of any hemoglobinopathy
- •History of intolerance or hypersensitivity to Fenugreek
研究组 & 干预措施
Control
One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract.
干预措施: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] (Drug)
Fenugreek
One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract.
干预措施: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] (Drug)
Fenugreek
One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract.
干预措施: Fenugreek Seed extract (Dietary Supplement)
结局指标
主要结局
Glycosylated hemoglobin (HbA1c)
时间窗: Change from baseline HbA1c over 12 weeks
HbA1c will be evaluated using Hb variant (HPLC)
次要结局
- Urinary sugar(Change from baseline Urinary over 12 weeks)
- Post-prandial Blood Glucose(Change from baseline post-prandial Blood Glucose over 12 weeks)
- Fasting blood glucose(Change from baseline Fasting Blood Glucose over 12 weeks)
- Serum Insulin(Change from baseline Serum Insulin over 12 weeks)
- Serum C-Peptide(Change from baseline Serum C-Peptide over 12 weeks)
- Renal Function Test(Change from baseline Renal function test over 12 weeks)
- Liver Function Test(Change from baseline Liver function test over 12 weeks)
- Hematology (whole blood cell count)(Change from baseline Hematology over 12 weeks)
研究者
Dr Debasish Hota
Professor & Head
All India Institute of Medical Sciences, Bhubaneswar