Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study

Conditions
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Type-2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]
* Dietary Supplement: Fenugreek Seed extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek extract. | Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]<br>* Patients receiving either of the following oral hypoglycemic agents Sulfonylurea based oral hypoglycemic agents Metformin based oral hypoglycemic agents Metformin plus Sulfonylurea based oral hypoglycemic agents<br>* Other names: Metformin, Sulfonylurea;|
| Experimental: Fenugreek<br>One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract. | Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]<br>* Patients receiving either of the following oral hypoglycemic agents Sulfonylurea based oral hypoglycemic agents Metformin based oral hypoglycemic agents Metformin plus Sulfonylurea based oral hypoglycemic agents<br>* Other names: Metformin, Sulfonylurea;Dietary Supplement: Fenugreek Seed extract<br>* Patients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy<br>* Other names: Capsule Fenfuro 500 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbA1c) | HbA1c will be evaluated using Hb variant (HPLC) | Change from baseline HbA1c over 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood glucose | METHOD : SPECTROPHOTOMETRY HEXOKINASE | Change from baseline Fasting Blood Glucose over 12 weeks | 
| Serum Insulin | by CHEMILUMINESCENCE method | Change from baseline Serum Insulin over 12 weeks | 
| Serum C-Peptide | by CHEMILUMINESCENCE method | Change from baseline Serum C-Peptide over 12 weeks | 
| Renal Function Test | by Spectrophotometry | Change from baseline Renal function test over 12 weeks | 
| Liver Function Test | by Spectrophotometry | Change from baseline Liver function test over 12 weeks | 
| Hematology (whole blood cell count) | Automated particle cell counter and microscopy | Change from baseline Hematology over 12 weeks | 
| Urinary sugar | Semi-quantitative Biochemical test | Change from baseline Urinary over 12 weeks | 
| Post-prandial Blood Glucose | METHOD: SPECTROPHOTOMETRY HEXOKINASE | Change from baseline post-prandial Blood Glucose over 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fenugreek seed extract, HbA1c, Blood glucose