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Trial record 5 of 21 for:    fenugreek

Evaluation of Fenugreek Seed Extract In Type- 2 Diabetes: An Add-On Study

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ClinicalTrials.gov Identifier: NCT02700477
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Chemical Resources

Brief Summary:

Trigonella Foenum-Graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of anti-diabetic compounds Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems.

Preliminary animal and human trials suggest possible hypoglycemic and anti-hyper lipidemic properties of Fenugreek seed powder, when taken orally. Fenugreek seeds contain 50% fiber (30% soluble fiber and 20% insoluble fiber) that can slow the rate of post-prandial glucose absorption. This may be a secondary mechanism for the hypoglycemic effect.


Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Fenugreek seeds extract Other: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of Fenugreek Seed Extract In Patients With Type- 2 Diabetes: An Add-On Study
Study Start Date : July 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fenugreek

Arm Intervention/treatment
Active Comparator: Fenugreek seed extract
Fenugreek seeds extract 500 mg capsule twice a day for 12 weeks
Dietary Supplement: Fenugreek seeds extract
Fenugreek seed extract 500mg, BD
Other Name: Fenfuro

Placebo Comparator: Placebo
Placebo capsule containing Dicalcium Phosphate 500mg, BD
Other: Placebo
Placebo capsule containing Dicalcium Phosphate 500mg, BD




Primary Outcome Measures :
  1. Fasting blood sugar levels [ Time Frame: 12 weeks ]
    Reduction in fasting blood sugar levels (FBS) (mg/dL)

  2. Post prandial blood sugar levels [ Time Frame: 12 weeks ]
    Reduction in post prandial blood sugar levels (mg/dL)


Secondary Outcome Measures :
  1. Glycosylated haemoglobin (HbA1C)(%) [ Time Frame: 12 weeks ]
    Reduction in glycosylated haemoglobin



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Either gender & Attending diabetic clinical at hospital
  • Type-2 DM <5 years duration
  • On oral hypoglycaemic agents( Metformin±Sulfonylurea)
  • No change in anti-diabetic treatment for the last one month
  • HbA1c >7.5%
  • Fasting plasma glucose not exceeding 180mg/dL
  • Patient able to make proper use of medication.
  • Patients willing to provide signed informed consent

Exclusion Criteria:

  • Diabetes other than type 2 diabetes mellitus
  • Evidence of renal disease (Serum creatinine > 1.5mg/ml)
  • Evidence of liver disease (aspartate transaminase (AST) and alanine transaminase (ALT) >3 times of normal)
  • Pregnant and lactating mothers and women intending pregnancy
  • Participation in any other clinical trial with in the last 30 days
  • History of any hemoglobinopathy that may affect determination of Glycosylated Haemoglobin
  • Treatment with oral anti-diabetic agents (other than Metformin or SU) during the 12 weeks before baseline visit.
  • History of intolerance or hypersensitivity to sulfonylurea or Metformin or Fenugreek seed extract.
  • Any condition which in the opinion of the PI is significant and can make the patient unsuitable for study or can place it under additional risk.

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): NCT02700477


Sponsors and Collaborators
Chemical Resources
Investigators
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Principal Investigator: Dr Narsingh Verma, MD Dept of Physiology,King George's Medical University, Lucknow, UP, India

Publications of Results:
Other Publications:
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Responsible Party: Chemical Resources
ClinicalTrials.gov Identifier: NCT02700477     History of Changes
Other Study ID Numbers: Protocol No. CR001/02/13
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016

Keywords provided by Chemical Resources:
Type-2 Diabetic
HbA1c
FBS
PPBS
C-peptide

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Fenugreek seed meal
Hypoglycemic Agents
Physiological Effects of Drugs