Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes
- Conditions
- Type-2 Diabetes Mellitus
- Interventions
- Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]Dietary Supplement: Fenugreek Seed extract
- Registration Number
- NCT02693392
- Lead Sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract. Fenugreek Fenugreek Seed extract One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract. Fenugreek Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract.
- Primary Outcome Measures
Name Time Method Glycosylated hemoglobin (HbA1c) Change from baseline HbA1c over 12 weeks HbA1c will be evaluated using Hb variant (HPLC)
- Secondary Outcome Measures
Name Time Method Renal Function Test Change from baseline Renal function test over 12 weeks by Spectrophotometry
Liver Function Test Change from baseline Liver function test over 12 weeks by Spectrophotometry
Hematology (whole blood cell count) Change from baseline Hematology over 12 weeks Automated particle cell counter and microscopy
Urinary sugar Change from baseline Urinary over 12 weeks Semi-quantitative Biochemical test
Fasting blood glucose Change from baseline Fasting Blood Glucose over 12 weeks METHOD : SPECTROPHOTOMETRY HEXOKINASE
Serum Insulin Change from baseline Serum Insulin over 12 weeks by CHEMILUMINESCENCE method
Serum C-Peptide Change from baseline Serum C-Peptide over 12 weeks by CHEMILUMINESCENCE method
Post-prandial Blood Glucose Change from baseline post-prandial Blood Glucose over 12 weeks METHOD: SPECTROPHOTOMETRY HEXOKINASE
Trial Locations
- Locations (1)
Department of Medicine and Department of Pharmacology, AIIMS
🇮🇳Bhubaneswar, Odisha, India