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

Phase 4

Completed

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

• Registration Number: NCT04222738
• Lead Sponsor: Yaounde Central Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-12-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Study First Submitted: 2019-03-05
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-06
• Last Update Submitted: 2020-01-06
• Study First Posted: 2020-01-10
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Variation of mitral E' velocity	6 weeks	The mitral E' velocity is one of the methods for evaluating diastolic function.

Secondary Outcome Measures

Name	Time	Method
Variation of blood pressure.	6 weeks	Change in systolic and diastolic blood pressure by using ABPM (mmHg)
Variation of weight loss	6 weeks	Change in weight (Kgs)
Variation of HbA1c	6 weeks	Change in HbA1c (%)
Variation of transmitral flow parameters such as E velocity	6 weeks	E (early diastolic filling velocity)
Variation of lipid profile.	6 weeks	Change of triglycerides, LDL cholesterol, HDL cholesterol

Trial Locations

Locations (1)

Yaounde Central Hospital, NAtional Obesity Center; 🇨🇲 Yaounde, Cameroon