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

August 15, 2018 updated by: Dr Debasish Hota, All India Institute of Medical Sciences, Bhubaneswar

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • Department of Medicine and Department of Pharmacology, AIIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: 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
Other Names:
  • Metformin, Sulfonylurea
Experimental: 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.
Drug: 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
Other Names:
  • Metformin, Sulfonylurea
Dietary supplement: 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
Other Names:
  • Capsule Fenfuro 500 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated hemoglobin (HbA1c)
Time Frame: Change from baseline HbA1c over 12 weeks
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
Time Frame: Change from baseline Fasting Blood Glucose over 12 weeks
METHOD : SPECTROPHOTOMETRY HEXOKINASE
Change from baseline Fasting Blood Glucose over 12 weeks
Serum Insulin
Time Frame: Change from baseline Serum Insulin over 12 weeks
by CHEMILUMINESCENCE method
Change from baseline Serum Insulin over 12 weeks
Serum C-Peptide
Time Frame: Change from baseline Serum C-Peptide over 12 weeks
by CHEMILUMINESCENCE method
Change from baseline Serum C-Peptide over 12 weeks
Renal Function Test
Time Frame: Change from baseline Renal function test over 12 weeks
by Spectrophotometry
Change from baseline Renal function test over 12 weeks
Liver Function Test
Time Frame: Change from baseline Liver function test over 12 weeks
by Spectrophotometry
Change from baseline Liver function test over 12 weeks
Hematology (whole blood cell count)
Time Frame: Change from baseline Hematology over 12 weeks
Automated particle cell counter and microscopy
Change from baseline Hematology over 12 weeks
Urinary sugar
Time Frame: Change from baseline Urinary over 12 weeks
Semi-quantitative Biochemical test
Change from baseline Urinary over 12 weeks
Post-prandial Blood Glucose
Time Frame: Change from baseline post-prandial Blood Glucose over 12 weeks
METHOD: SPECTROPHOTOMETRY HEXOKINASE
Change from baseline post-prandial Blood Glucose over 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Collaborators

Chemical Resources

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2016

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

August 16, 2018

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

February 26, 2016

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T/EM-F/Pharma/14/05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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