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

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

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.

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.

One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up without add-on fenugreek 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.

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

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

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

Gupta A, Gupta R, Lal B. Effect of Trigonella foenum-graecum (fenugreek) seeds on glycaemic control and insulin resistance in type 2 diabetes mellitus: a double blind placebo controlled study. J Assoc Physicians India. 2001 Nov;49:1057-61.

Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7.

Baquer NZ, Kumar P, Taha A, Kale RK, Cowsik SM, McLean P. Metabolic and molecular action of Trigonella foenum-graecum (fenugreek) and trace metals in experimental diabetic tissues. J Biosci. 2011 Jun;36(2):383-96. doi: 10.1007/s12038-011-9042-0.

Hannan JM, Ali L, Rokeya B, Khaleque J, Akhter M, Flatt PR, Abdel-Wahab YH. Soluble dietary fibre fraction of Trigonella foenum-graecum (fenugreek) seed improves glucose homeostasis in animal models of type 1 and type 2 diabetes by delaying carbohydrate digestion and absorption, and enhancing insulin action. Br J Nutr. 2007 Mar;97(3):514-21. doi: 10.1017/S0007114507657869.