Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807118168502 Date of Approval: 30/07/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of Ginger Powder Supplementation on Glycemic Status and Lipid Profile in Patients with Type 2 Diabetes Mellitus
Official scientific title Effects of Ginger Powder Supplementation on Glycemic Status and Lipid Profile in Patients with Type 2 Diabetes Mellitus
Brief summary describing the background and objectives of the trial Diabetes is reaching pandemic levels in both developing and developed countries and requires safe, affordable, and effective therapies. The use of dietary supplements for the treatment of Type 2 Diabetes Mellitus has always been encouraged by ancient medical practitioners, a practice which has now gained considerable attention from researchers who wish to discover the biopharmaceutical activities of these dietary supplements. Ginger - the rhizome of the plant Zingiber officinale which also referred to as the ¿root¿ - is indigenous to Southeast Asia where its cultivation dates back about 3,000 years in India. Today its use has spread to most of the world. It is expected that the multiple components in ginger may lead to multiple effects on metabolic pathways and to involve multiple mechanisms affecting various aspects of chronic metabolic disorders such as diabetes. The aim of the present study was to evaluate the effects of ginger powder supplementation on glycemic status, lipid profile, insulin resistance, insulin sensitivity, and beta-cell function in obese Egyptian adult patients with new-onset Type 2 Diabetes Mellitus.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2016
Actual trial start date 30/01/2016
Anticipated date of last follow up 01/01/2017
Actual Last follow-up date 24/01/2017
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
Publication URL in the process of publication.
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ginger Group (Group 1) One 600 mg capsule of Ginger 3 times daily + One 850 mg tablet of Metformin twice daily 8 weeks The total daily dose received by subjects was 1.8 g for Ginger and 1.7 g for Metformin. 40
Control Group Placebo Group (Group 2) One capsule of wheat flour 3 times daily + One 850 mg tablet of Metformin twice daily 8 weeks The total daily dose received by subjects was 2 g for wheat flour and 1.7 g for Metformin. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Newly diagnosed type 2 diabetes mellitus, Glycated hemoglobin (HbA1c) level < 9%, Body Mass Index (BMI) ≥ 30 kg/ m2. Diabetes duration more than 6 months, HbA1c level ≥ 9%, BMI < 30 kg/ m2, Insulin therapy, Any injectable or oral antidiabetic medication other than metformin, Any acute illnesses at baseline or during the study, Smoking, Consumption of less than 80% of the capsules, Any sensitivity due to ginger consumption reported by the patient or noticed after the outset of the study, Consumption of vitamin, mineral or other nutritional supplements, Consumption of alcohol or narcotic drugs, Pregnancy or lactation, Any thyroid or autoimmune disorder, Ischemic, cardiac or renal diseases, Chronic inflammatory diseases, Peptic ulcer, Regular consumption of ginger or other herbal drugs, Consumption of lipid lowering drugs or oral contraceptive pills. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 31 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2016 Faculty of Medicine Ain Shams University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, Ain Shams University, Abbasia. Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Fasting blood glucose, 2hour-postprandial blood glucose, Glycated hemoglobin, Total cholesterol, Triglycerides, Low density lipoprotein cholesterol, High density lipoprotein cholesterol At Baseline, At end of the study.
Secondary Outcome Fasting insulin level, Homeostatic model assessment (HOMA2) indices: Insulin resistance (HOMA2 - IR), Insulin sensitivity (HOMA2 - %S), Beta-cell function (HOMA2 - %β) At Baseline, At end of the study.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
National Institute of Diabetes and Endocrinology 16th A, Kasr Al-Ainy St. Cairo 11562 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Moustafa Hussein ( Self funding) 4th, Ahmed Dawood St. off Mohamed Ali St., EL Sheikh Khalil, 3rd floor, Shobra El-Balad. Cairo 13769 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Ain Shams University Abbasia Cairo 11591 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Prof. Dr. Eman Sultan (National Institute of Nutrition) 16th A, Kasr Al-Ainy St. Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Moustafa Hussein Dr.Moustafa.Hussein.A@gmail.com +201099959017 4th, Ahmed Dawood St. off Mohamed Ali St., EL Sheikh Khalil, 3rd floor, Shobra El-Balad
City Postal code Country Position/Affiliation
Cairo 13769 Egypt Senior Resident / National Institute of Diabetes and Endocrinology
Role Name Email Phone Street address
Public Enquiries Moustafa Hussein Dr.Moustafa.Hussein.A@gmail.com +201099959017 4th, Ahmed Dawood St. off Mohamed Ali St., EL Sheikh Khalil, 3rd floor, Shobra El-Balad
City Postal code Country Position/Affiliation
Cairo 13769 Egypt Senior Resident / National Institute of Diabetes and Endocrinology
Role Name Email Phone Street address
Scientific Enquiries Moustafa Hussein Dr.Moustafa.Hussein.A@gmail.com +201099959017 4th, Ahmed Dawood St. off Mohamed Ali St., EL Sheikh Khalil, 3rd floor, Shobra El-Balad
City Postal code Country Position/Affiliation
Cairo 13769 Egypt Senior Resident / National Institute of Diabetes and Endocrinology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information