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NCT Number: NCT02693392

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

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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Key information

Conditions

Type-2 Diabetes Mellitus

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine and Department of Pharmacology, AIIMS

Bhubaneswar, Odisha, 751019, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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 names: Metformin, Sulfonylurea

Fenugreek Seed extract

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

Other names: Capsule Fenfuro 500 mg

Primary outcomes

  1. Glycosylated hemoglobin (HbA1c)

    Time frame: Change from baseline HbA1c over 12 weeks

    HbA1c will be evaluated using Hb variant (HPLC)

Secondary outcomes

  1. Fasting blood glucose

    Time frame: Change from baseline Fasting Blood Glucose over 12 weeks

    METHOD : SPECTROPHOTOMETRY HEXOKINASE

  2. Serum Insulin

    Time frame: Change from baseline Serum Insulin over 12 weeks

    by CHEMILUMINESCENCE method

  3. Serum C-Peptide

    Time frame: Change from baseline Serum C-Peptide over 12 weeks

    by CHEMILUMINESCENCE method

  4. Renal Function Test

    Time frame: Change from baseline Renal function test over 12 weeks

    by Spectrophotometry

  5. Liver Function Test

    Time frame: Change from baseline Liver function test over 12 weeks

    by Spectrophotometry

  6. Hematology (whole blood cell count)

    Time frame: Change from baseline Hematology over 12 weeks

    Automated particle cell counter and microscopy

  7. Urinary sugar

    Time frame: Change from baseline Urinary over 12 weeks

    Semi-quantitative Biochemical test

  8. Post-prandial Blood Glucose

    Time frame: Change from baseline post-prandial Blood Glucose over 12 weeks

    METHOD: SPECTROPHOTOMETRY HEXOKINASE

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Collaborators

  • Chemical Resources

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2016
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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