The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus

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

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2017-05-31

Brief Summary

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The aim of the study was the evaluation of cardiovascular benefits of Zingiber officinale Roscoe in patients with type 2 diabetes mellitus before and after 6 weeks of add-on therapy.

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Detailed Description

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the investigators performed a non-randomized single-arm clinical trial with a before and after design, carried out from December 2016 and May 2017.

Intervention consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day, for a period of 6 weeks. Before and after intervention, the following were done by the participants: bioelectrical impedance analysis (BIA), blood pressure measurements, fasting blood sugar, HbA1c, lipid profiles, liver function tests, kidney function tests and full blood counts. These were followed by morphological workup including Electrocardiograms (ECGs), transthoracic heart ultrasounds and Ambulatory Blood Pressure Measurements (ABPM), also done before and after intervention.

Clinical evaluation with fasting blood sugar control and blood pressure controls were done at day 21 for safety purposes.

Conditions

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Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-randomized single-arm of GINOFF1

Non-randomized single-arm clinical trial with a before and after design. The study population consisted on all type 2 diabetes mellitus (T2DM) patients with a target population of T2DM patients with HbA1c between 42 to 64mmol/mol (6-8%) with no change in anti-diabetic treatment during the last three months, previous the study.

The intervention consisted on the administration of Zingiber officinale Roscoe extracts, at a daily dose of 2g/day (equivalent overall daily dose of extract in simple powdered form) for a period of 6weeks. The extracts were given as capsules, either one capsule three times per day (1 capsule x 3 / day) and after meals. Each capsule contains 399mg of pure Zingiber officinale Roscoe extracts.

Group Type EXPERIMENTAL

GINOFF1

Intervention Type DIETARY_SUPPLEMENT

The intervention lasted for six weeks and consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day.

Interventions

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GINOFF1

The intervention lasted for six weeks and consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Known T2DM patients aged above 21years
* No change in anti-diabetic medication during the last three months.
* HbA1c between 42 to 64mmol/mol (6-8%).

Exclusion Criteria

* Patient already on ginger supplementation or other herbal medication
* Drugs that could interact with ginger or whose effects may be amplified such as NSAIDS, corticosteroids and anticoagulants like heparin or warfarin, as far back as 1 month before study.
* Cardiac, renal disease and liver pathologies
* Heartburn or peptic ulcer disease
* Sensitivity, intolerance or allergy to ginger
* Discontinued intervention
* Withdrawal of consent

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No