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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-17

Study Completion Date

2018-08-16

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.

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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.

Conditions

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Type-2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Patients receiving either of the following oral hypoglycemic agents

1. Sulfonylurea based oral hypoglycemic agents
2. Metformin based oral hypoglycemic agents
3. Metformin plus Sulfonylurea based oral hypoglycemic agents

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Patients receiving either of the following oral hypoglycemic agents

1. Sulfonylurea based oral hypoglycemic agents
2. Metformin based oral hypoglycemic agents
3. Metformin plus Sulfonylurea based oral hypoglycemic agents

Fenugreek Seed extract

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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

Patients receiving either of the following oral hypoglycemic agents

1. Sulfonylurea based oral hypoglycemic agents
2. Metformin based oral hypoglycemic agents
3. Metformin plus Sulfonylurea based oral hypoglycemic agents

Intervention Type DRUG

Fenugreek Seed extract

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Metformin, Sulfonylurea Capsule Fenfuro 500 mg

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No