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Trial record 8 of 23 for:    fenugreek

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

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ClinicalTrials.gov Identifier: NCT02693392
Recruitment Status : Completed
First Posted : February 26, 2016
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Chemical Resources
Information provided by (Responsible Party):
Dr Debasish Hota, 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.

Condition or disease Intervention/treatment Phase
Type-2 Diabetes Mellitus Drug: Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea] Dietary Supplement: Fenugreek Seed extract Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Fenugreek Seed Extract, a Nutraceutical in Patients With Type- 2 Diabetes: An Add-On Study
Actual Study Start Date : January 17, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : August 16, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Capsule Fenfuro 500 mg




Primary Outcome Measures :
  1. Glycosylated hemoglobin (HbA1c) [ Time Frame: Change from baseline HbA1c over 12 weeks ]
    HbA1c will be evaluated using Hb variant (HPLC)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02693392


Locations
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India
Department of Medicine and Department of Pharmacology, AIIMS
Bhubaneswar, Odisha, India, 751019
Sponsors and Collaborators
All India Institute of Medical Sciences, Bhubaneswar
Chemical Resources

Publications of Results:
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Responsible Party: Dr Debasish Hota, Professor & Head, All India Institute of Medical Sciences, Bhubaneswar
ClinicalTrials.gov Identifier: NCT02693392     History of Changes
Other Study ID Numbers: T/EM-F/Pharma/14/05
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr Debasish Hota, All India Institute of Medical Sciences, Bhubaneswar:
Fenugreek seed extract
HbA1c
Blood glucose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Fenugreek seed meal
Hypoglycemic Agents
Physiological Effects of Drugs