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Completed

NCT Number: NCT04222738

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

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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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GINOFF1

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.

Primary outcomes

  1. Variation of mitral E' velocity

    Time frame: 6 weeks

    The mitral E' velocity is one of the methods for evaluating diastolic function.

Secondary outcomes

  1. Variation of transmitral flow parameters such as E velocity

    Time frame: 6 weeks

    E (early diastolic filling velocity)

  2. Variation of blood pressure.

    Time frame: 6 weeks

    Change in systolic and diastolic blood pressure by using ABPM (mmHg)

  3. Variation of weight loss

    Time frame: 6 weeks

    Change in weight (Kgs)

  4. Variation of HbA1c

    Time frame: 6 weeks

    Change in HbA1c (%)

  5. Variation of lipid profile.

    Time frame: 6 weeks

    Change of triglycerides, LDL cholesterol, HDL cholesterol

Sponsors and collaborators

Lead sponsor

Yaounde Central Hospital

Other Gov

Collaborators

  • MBANYA Jean Claude, Pr
  • NGATI Denetria NYONGA, Dr
  • SOBNGWI Eugène, Pr

Registry information

Official study title

Short Term Cardiovascular Effects of Zingiber Officinale as add-on Therapy in a Population of Type 2 Diabetes Individuals

Acronym: GINOFF1

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 10, 2020
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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