NCT02700477

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for phase_4 diabetes

Timeline
Completed

Started Jul 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

September 29, 2015

Last Update Submit

March 2, 2016

Conditions

Diabetes

Keywords

Type-2 DiabeticHbA1cFBSPPBSC-peptide

Outcome Measures

Primary Outcomes (2)

  • Fasting blood sugar levels

    Reduction in fasting blood sugar levels (FBS) (mg/dL)

    12 weeks

  • Post prandial blood sugar levels

    Reduction in post prandial blood sugar levels (mg/dL)

    12 weeks

Secondary Outcomes (1)

  • Glycosylated haemoglobin (HbA1C)(%)

    12 weeks

Study Arms (2)

Fenugreek seed extract

ACTIVE COMPARATOR

Fenugreek seeds extract 500 mg capsule twice a day for 12 weeks

Dietary Supplement: Fenugreek seeds extract

Placebo

PLACEBO COMPARATOR

Placebo capsule containing Dicalcium Phosphate 500mg, BD

Other: Placebo

Interventions

Fenugreek seeds extractDIETARY_SUPPLEMENT

Fenugreek seed extract 500mg, BD

Also known as: Fenfuro
Fenugreek seed extract
PlaceboOTHER

Placebo capsule containing Dicalcium Phosphate 500mg, BD

Placebo

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Chehade JM, Gladysz M, Mooradian AD. Dyslipidemia in type 2 diabetes: prevalence, pathophysiology, and management. Drugs. 2013 Mar;73(4):327-39. doi: 10.1007/s40265-013-0023-5.

    PMID: 23479408BACKGROUND

  • Verma R, Khanna P, Mehta B. National programme on prevention and control of diabetes in India: Need to focus. Australas Med J. 2012;5(6):310-5. doi: 10.4066/AMJ.2012.1340. Epub 2012 Jun 30. No abstract available.

    PMID: 22848329RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dr Narsingh Verma, MD

    Dept of Physiology,King George's Medical University, Lucknow, UP, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

March 7, 2016

Study Start

July 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

March 7, 2016

Record last verified: 2016-03