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| Name | Class |
|---|---|
| NGATI Denetria NYONGA, Dr | UNKNOWN |
| SOBNGWI Eugène, Pr | UNKNOWN |
| MBANYA Jean Claude, Pr | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-randomized single-arm of GINOFF1 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GINOFF1 | Dietary Supplement | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Variation of mitral E' velocity | The mitral E' velocity is one of the methods for evaluating diastolic function. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of transmitral flow parameters such as E velocity | E (early diastolic filling velocity) | 6 weeks |
| Variation of blood pressure. | Change in systolic and diastolic blood pressure by using ABPM (mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Nadege NGANOU-GNINDJIO, MD, MAS | Yaounde Central Hospital | Principal Investigator |
| Eugene SOBNGWI, Professor | Yaounde Central Hospital | Study Director |
| Jean Claude MBANYA, Professor | Yaounde Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yaounde Central Hospital, NAtional Obesity Center | Yaoundé | Cameroon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35039142 | Derived | Nganou-Gnindjio CN, Ngati Nyonga D, Wafeu GS, Nga EN, Sobngwi E. Cardiometabolic effects of ZingiberOfficinale Roscoe extracts in Type 2 diabetic Cameroonians patients after six weeks of add-on Therapy : A single clinical-arm trial. Ann Cardiol Angeiol (Paris). 2022 Jun;71(3):160-165. doi: 10.1016/j.ancard.2021.09.010. Epub 2022 Jan 14. French. |
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| 6 weeks |
| Variation of weight loss | Change in weight (Kgs) | 6 weeks |
| Variation of HbA1c | Change in HbA1c (%) | 6 weeks |
| Variation of lipid profile. | Change of triglycerides, LDL cholesterol, HDL cholesterol | 6 weeks |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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