NCT04222738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 10, 2020

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

March 5, 2019

Last Update Submit

January 6, 2020

Conditions

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

Keywords

Diabetes mellitusDiastolic functionBlood pressureZingiber officinale

Outcome Measures

Primary Outcomes (1)

  • Variation of mitral E' velocity

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

    6 weeks

Secondary Outcomes (5)

  • Variation of transmitral flow parameters such as E velocity

    6 weeks

  • Variation of blood pressure.

    6 weeks

  • Variation of weight loss

    6 weeks

  • Variation of HbA1c

    6 weeks

  • Variation of lipid profile.

    6 weeks

Study Arms (1)

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.

Dietary Supplement: GINOFF1

Interventions

GINOFF1DIETARY_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.

Non-randomized single-arm of GINOFF1

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yaounde Central Hospital, NAtional Obesity Center

Yaoundé, Cameroon

Location

Related Publications (1)

  • 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.

    PMID: 35039142DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr, Principal investigator

Study Record Dates

First Submitted

March 5, 2019

First Posted

January 10, 2020

Study Start

December 1, 2016

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

CA(1)