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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Cameroon
Study Type
Interventional
Intervention
GINOFF1
Sponsored by
Yaounde Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy focused on measuring Diabetes mellitus, Diastolic function, Blood pressure, Zingiber officinale

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yaounde Central Hospital, NAtional Obesity Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-randomized single-arm of GINOFF1

Arm 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.

Outcomes

Primary Outcome Measures

Variation of mitral E' velocity
The mitral E' velocity is one of the methods for evaluating diastolic function.

Secondary Outcome Measures

Variation of transmitral flow parameters such as E velocity
E (early diastolic filling velocity)
Variation of blood pressure.
Change in systolic and diastolic blood pressure by using ABPM (mmHg)
Variation of weight loss
Change in weight (Kgs)
Variation of HbA1c
Change in HbA1c (%)
Variation of lipid profile.
Change of triglycerides, LDL cholesterol, HDL cholesterol

Full Information

First Posted
March 5, 2019
Last Updated
January 6, 2020
Sponsor
Yaounde Central Hospital
Collaborators
NGATI Denetria NYONGA, Dr, SOBNGWI Eugène, Pr, MBANYA Jean Claude, Pr
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1. Study Identification

Unique Protocol Identification Number
NCT04222738
Brief Title
The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus
Acronym
GINOFF1
Official Title
Short Term Cardiovascular Effects of Zingiber Officinale as add-on Therapy in a Population of Type 2 Diabetes Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yaounde Central Hospital
Collaborators
NGATI Denetria NYONGA, Dr, SOBNGWI Eugène, Pr, MBANYA Jean Claude, Pr

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Benefits of Zingiber Officinale Roscoe in Patients With Type 2 Diabetes Mellitus Before and After 6 Weeks of add-on Therapy
Keywords
Diabetes mellitus, Diastolic function, Blood pressure, Zingiber officinale

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-randomized single-arm of GINOFF1
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
GINOFF1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Variation of mitral E' velocity
Description
The mitral E' velocity is one of the methods for evaluating diastolic function.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Variation of transmitral flow parameters such as E velocity
Description
E (early diastolic filling velocity)
Time Frame
6 weeks
Title
Variation of blood pressure.
Description
Change in systolic and diastolic blood pressure by using ABPM (mmHg)
Time Frame
6 weeks
Title
Variation of weight loss
Description
Change in weight (Kgs)
Time Frame
6 weeks
Title
Variation of HbA1c
Description
Change in HbA1c (%)
Time Frame
6 weeks
Title
Variation of lipid profile.
Description
Change of triglycerides, LDL cholesterol, HDL cholesterol
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Nadege NGANOU-GNINDJIO, MD, MAS
Organizational Affiliation
Yaounde Central Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugene SOBNGWI, Professor
Organizational Affiliation
Yaounde Central Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean Claude MBANYA, Professor
Organizational Affiliation
Yaounde Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yaounde Central Hospital, NAtional Obesity Center
City
Yaounde
Country
Cameroon

12. IPD Sharing Statement

Citations:
PubMed Identifier
35039142
Citation
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.
Results Reference
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The Cardiovascular Effects of Ginger (Zingiber Officinale) in Patients With Type II Diabetes Mellitus

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