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

All India Institute of Medical Sciences, Bhubaneswar

Status: Completed

Conditions: Type-2 Diabetes Mellitus

Treatments: Dietary Supplement: Fenugreek Seed extract; Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02693392

T/EM-F/Pharma/14/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]

Fenugreek

Experimental group

Description:

One hundred type-2 diabetes patients with standard oral hypoglycemic drugs (metformin +/- sulfonylurea) will be recruited and followed up with add-on fenugreek extract.

Treatment:

Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]

Dietary Supplement: Fenugreek Seed extract