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Trial record 11 of 24 for:    fenugreek

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

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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

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE February 28, 2017
Last Update Posted Date January 31, 2018
Actual Study Start Date  ICMJE December 14, 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Change in Fasting Blood Sugar [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
  • Change in Postprandial sugar [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03066089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2017)
  • Change in HbA1c levels [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
  • SGPT,SGOT,ALP,Creatinine,TLC,DLC & Hb [ Time Frame: On completion of treatment (i.e.12 weeks) as compared to baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Fenfuro (Fenugreek Seed Extract) in Type-2 Diabetic Subjects: an add-on Study
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE Drug: Fenfuro
Other Name: Fenugreek seed extract
Study Arms  ICMJE
  • Experimental: Group A
    Fenfuro 500 mg capsule by mouth, BD (two times a day), till next follow-up
    Intervention: Drug: Fenfuro
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2018)
104
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2017)
100
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03066089
Other Study ID Numbers  ICMJE CR-FEN/PREDIA/02/15
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chemical Resources
Study Sponsor  ICMJE Chemical Resources
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chemical Resources
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP