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

NCT ID: NCT03066089

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-14

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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FBS,HbA1C, PPBS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A

Fenfuro 500 mg capsule by mouth, BD (two times a day), till next follow-up

Group Type EXPERIMENTAL

Fenfuro

Intervention Type DRUG

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fenfuro

Intervention Type DRUG

Other Intervention Names

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Fenugreek seed extract

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chemical Resources

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gian Sagar Medical College & Hospital

Rajpura, Punjab, India

Site Status

Countries

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India

Other Identifiers

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CR-FEN/PREDIA/02/15

Identifier Type: -

Identifier Source: org_study_id