Short Term Cardiovascular Effects of Zingiber Officinale as add-on Therapy in a Population of Type 2 Diabetes Individuals
| Registry | NCT04222738, acronym GINOFF1 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; na, single group, masking: none, treatment |
| Enrollment | 21 (Actual) |
| Sponsor | Yaounde Central Hospital (Other gov); collaborators: NGATI Denetria NYONGA, Dr, SOBNGWI Eugène, Pr, MBANYA Jean Claude, Pr |
| Conditions | Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy |
| Interventions | GINOFF1 (Dietary supplement) |
| Dates | start 2016-12-01, primary completion 2017-05-31, completion 2017-05-31, first posted 2020-01-10, last updated 2020-01-10 |
| Locations | 1 site in Cameroon |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy All trials of GINOFF1
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Non-randomized single-arm of GINOFF1 | Experimental | Dietary Supplement: 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. |
Sex: All, ages: 21 Years to 75 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Yaounde Central Hospital, NAtional Obesity Center | Yaoundé | Cameroon |