The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus (GINOFF1)

Yaounde Central Hospital

Status and phase: Completed; Phase 4

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

Treatments: Dietary Supplement: GINOFF1

Study type: Interventional

Funder types: Other

Identifiers

NCT04222738

Ginger and type 2 diabetes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

21 participants in 1 patient group

Non-randomized single-arm of GINOFF1

Experimental group

Description:

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.

Treatment:

Dietary Supplement: GINOFF1