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

Sponsors

Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Collaborator: Chemical Resources

Source 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.

Overall Status Completed
Start Date 2016-01-17
Completion Date 2018-08-16
Primary Completion Date 2018-04-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glycosylated hemoglobin (HbA1c) Change from baseline HbA1c over 12 weeks
Secondary Outcome
Measure Time Frame
Fasting blood glucose Change from baseline Fasting Blood Glucose over 12 weeks
Serum Insulin Change from baseline Serum Insulin over 12 weeks
Serum C-Peptide Change from baseline Serum C-Peptide over 12 weeks
Renal Function Test Change from baseline Renal function test over 12 weeks
Liver Function Test Change from baseline Liver function test over 12 weeks
Hematology (whole blood cell count) Change from baseline Hematology over 12 weeks
Urinary sugar Change from baseline Urinary over 12 weeks
Post-prandial Blood Glucose Change from baseline post-prandial Blood Glucose over 12 weeks
Enrollment 200
Condition
Intervention

Intervention Type: Drug

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

Description: 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

Other Name: Metformin, Sulfonylurea

Intervention Type: Dietary Supplement

Intervention Name: Fenugreek Seed extract

Description: 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

Arm Group Label: Fenugreek

Other Name: Capsule Fenfuro 500 mg

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

25 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Location
Facility: Department of Medicine and Department of Pharmacology, AIIMS
Location Countries

India

Verification Date

2018-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: All India Institute of Medical Sciences, Bhubaneswar

Investigator Full Name: Dr Debasish Hota

Investigator Title: Professor & Head

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Control

Type: Active Comparator

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.

Label: Fenugreek

Type: Experimental

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

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