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NCT04222738 Clinical Trial

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

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

— GINOFF1  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04222738
Other study ID # Ginger and type 2 diabetes
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2016
Est. completion date May 31, 2017

Study information
Verified date January 2020
Source Yaounde Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date May 31, 2017
Est. primary completion date May 31, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• 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.

Locations
Country Name City State
Cameroon Yaounde Central Hospital, NAtional Obesity Center Yaounde

Sponsors (4)
Lead Sponsor Collaborator
Yaounde Central Hospital MBANYA Jean Claude, Pr, NGATI Denetria NYONGA, Dr, SOBNGWI Eugène, Pr

Country where clinical trial is conducted

Cameroon, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variation of mitral E' velocity The mitral E' velocity is one of the methods for evaluating diastolic function. 6 weeks
Secondary Variation of transmitral flow parameters such as E velocity E (early diastolic filling velocity) 6 weeks
Secondary Variation of blood pressure. Change in systolic and diastolic blood pressure by using ABPM (mmHg) 6 weeks
Secondary Variation of weight loss Change in weight (Kgs) 6 weeks
Secondary Variation of HbA1c Change in HbA1c (%) 6 weeks
Secondary Variation of lipid profile. Change of triglycerides, LDL cholesterol, HDL cholesterol 6 weeks