The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus
- Conditions
- Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy
- Interventions
- Dietary Supplement: GINOFF1
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
- 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%).
- 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
- Arm && Interventions
Group Intervention Description Non-randomized single-arm of GINOFF1 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.
- 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