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Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03066089
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Chemical Resources

Brief Summary:
This study is an open label, two armed trial evaluating the safety and efficacy of Fenfuro capsule twice daily for 90 days in 100 patients with type 2 diabetes that will be conducted in single center in India. The primary outcome measures will be the determination of decrease in plasma glucose levels from baseline to last visit. The secondary outcome will be the determination of safety of Fenfuro capsule in type 2 diabetic subjects.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Fenfuro Phase 4

Detailed Description:

Diabetes mellitus, involving rise in blood sugar levels, has shown to be a highly prevalent disease. Treatments and treatment regimens include combinations of oral anti-diabetic drugs (OADs), anti-hypertensive medications and anti-dyslipidemic agents, but these have been less than successful in managing their respective disease targets with clinical goals. Now-a-days, the treatment strategies for diabetes mellitus type 2 which are opted by general population include natural supplements. This choice is based upon the involvement of very less side effects along with high effectiveness of the natural supplements as compared to the synthetic medications. One of those natural supplements is fenugreek seeds extract i.e. Fenfuro which has been used as a nutraceutical in the present study for the management of type 2 diabetes mellitus.

Fenugreek has been extensively used as a source of anti-diabetic compounds from long time. Thus, Fenfuro, prepared from fenugreek seeds extract, is supposed to have anti-diabetic properties as well. Previous studies on fenugreek seeds extract have shown effective and safe anti-diabetic and anti-hyperlipidemic properties of it. It has shown to decrease blood glucose levels as well as lipid profile of the diabetic patients.

In this proposed study, Fenugreek seed extract will be used as an 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 : 104 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Open Labeled, Interventional, Two Armed, Single Centric Study to Assess the Efficacy of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study
Actual Study Start Date : December 14, 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fenugreek

Arm Intervention/treatment
Experimental: Group A
Fenfuro 500 mg capsule by mouth, BD (two times a day), till next follow-up
Drug: Fenfuro
Other Name: Fenugreek seed extract

No Intervention: Group B
Investigational product is not being administered to this arm. This arm will regularly be observed on follow-up and laboratory investigations will be performed.



Primary Outcome Measures :
  1. Change in Fasting Blood Sugar [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
  2. Change in Postprandial sugar [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]

Secondary Outcome Measures :
  1. Change in HbA1c levels [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
  2. SGPT,SGOT,ALP,Creatinine,TLC,DLC & Hb [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Agrees to written as well as audio-visual informed consent.
  • Patients of either sex.
  • Aged 18-65 years.
  • Fasting plasma glucose level <180 mg/dL.
  • HbA1c level more than 7.5%.
  • Not receiving any steroids.
  • Patient on anti-diabetic therapy.

Exclusion Criteria:

  • Uncooperative Subjects.
  • Diabetes other than type-2 diabetes mellitus.
  • Evidence of renal & liver disease.
  • History of any hemoglobinopathy that may affect determination of HbA1c.
  • Lactating and Pregnant or planning to conceive females.
  • Physically/ mentally unwell as certified by physician-in-charge.
  • Participation in any other clinical trial with in the last 30 days.
  • Subjects with allergy to investigational product.

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): NCT03066089


Locations
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India
Gian Sagar Medical College & Hospital
Rajpura, Punjab, India, 140601
Sponsors and Collaborators
Chemical Resources

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Responsible Party: Chemical Resources
ClinicalTrials.gov Identifier: NCT03066089     History of Changes
Other Study ID Numbers: CR-FEN/PREDIA/02/15
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chemical Resources:
FBS,HbA1C, PPBS
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Fenugreek seed meal
Hypoglycemic Agents
Physiological Effects of Drugs