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.: PACTR202202640395224 Date of Approval: 28/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving blood sugar control through patients’ choice of evidence-based spices and foods with hypoglycaemic effect – A pragmatic trial.
Official scientific title Improving blood sugar control through patients’ choice of evidence-based spices and foods with hypoglycaemic effect – A pragmatic trial.
Brief summary describing the background and objectives of the trial Type 2 diabetes patients often do not reach desired control of glycaemia despite guidance on changing lifestyle and diet as well as the use of conventional anti-diabetic medication. Parrallely in recent years, an array of comparative clinical studies have demonstrated the anti-diabetic effect of more than 10 common spices and food products. Objectives : to evaluate whether proposing a choice of spices and foods products with hypoglycaemic effect to diabetic patients is feasible and can help better control diabetes.
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 Physical activity and nutrition
Anticipated trial start date 01/04/2022
Actual trial start date
Anticipated date of last follow up 01/04/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 124
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL Willcox ML, Elugbaju C, Al-Anbaki M, Lown M and Graz B (2021) Effectiveness of Medicinal Plants for Glycaemic Control in Type 2 Diabetes: An Overview of Meta-Analyses of Clinical Trials. Front. Pharmacol. 12:777561. doi: 10.3389/fphar.2021.777561
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intervention group For each plant, several recipes are proposed in which the product is in the same state as in the reference clinical trial (e.g. a juice with limited heating), in order to minimize the active principles transformation. The dose of the plant will be also indicated and corresponds to the reference clinical trial. A patient's booklet summiraze all of these informations. 12 weeks A booklet with 4 common food products, clinically validated against diabetes, with instructions for use will be presented to the diabetic patient. The selected plants have been assessed as anti-diabetic for humans through at least one fair randomized comparative clinical trial, with a follow-up of several weeks or months. While continuing to take his/her standard medication if any, the patient will be encouraged to follow his/her preferences within the established list of foods and spices: he is expected to choose 2 plants from the list and to consume each of them every day during the whole duration of the trial. 62
Control Group Control Group nothing apart from the standard lifestyle and dietary recommendations 12weeks The control group will receive only lifestyle and dietary recommendations. Participants of both groups will continue to take their standard medication and/or traditional medicine, if applicable, during the whole duration of the trial. 62 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Type 2 diabetes patients with poorly controlled glycaemia, despite ≥6 months usual care (lifestyle + medication if applicable) + at least one of the following measurements: - Fasting plasma glucose (FPG) values > 7.0 mmol/L (126 mg/dl), - or 2-h post-load plasma glucose > 11.1 mmol/L (200 mg/dl), - or HbA1c > 6.5% (48 mmol/mol); - or a random blood glucose > 11.1 mmol/L (200 mg/ dl) . - If under medication, it has been remaining the same treatment and dosage for at least 3 months -- and it is planned to keep this treatment the same for the next 3 months - All severe complications of diabetes: end-organ damage such as nephropathy, retinopathy, neuropathy, etc... - Any health condition that requires urgent attention - Patients with a cognitive or sensory impairment that may prevent conducting the interview 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 18/02/2022 Institutional Ethical Review Board of the University of Gondar
Ethics Committee Address
Street address City Postal code Country
Makaki 196 Gondar 2000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Percentage of patients in each group reaching a decrease of ≥ 0.5mmol/L in FPG - Percentage of patients reaching a decrease of ≥ 0.5 points of percentage from the baseline value in HbA1c; each of these reductions being deemed as clinically significant. 12weeks
Secondary Outcome - Mean reduction of FPG and mean reduction of HbA1c e.g. differences between baseline values and values at 3 months; - Proportion of patient in each group reaching target glycaemia (<7mmol/L for FPG and <6,5% for HbA1c); - Mean change of weight and mean change of blood pressure e.g. differences between baseline values and values at 3 months; - Proportion of patients who wish to continue to take the plant after the intervention; - Assessment of adverse effects. 12weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Gondar Comprehensive Specialized Hospital outpatient department Maraki 196 Gondar Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Antenna Foundation Av. de la Grenade 24 Geneva 1207 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Antenna Foundation Av. de la Grenade 24 Geneva 1207 Switzerland Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
University of Gondar College of Medicine Maraki Gondar Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mezgebu Silamsaw Asres msilamsaw@gmail.com +251921576259 University street 2
City Postal code Country Position/Affiliation
Gondar Ethiopia Assistant Professor
Role Name Email Phone Street address
Public Enquiries Abyot Endale abyot.endale@gmail.com +251913399986 Next to the airport 1
City Postal code Country Position/Affiliation
Gondar Ethiopia Head of the School of the Pharmacy
Role Name Email Phone Street address
Scientific Enquiries Shitaye Alemu shitayea@yahoo.com +2519999999 University street 3
City Postal code Country Position/Affiliation
Gondar Ethiopia Medical Director
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Will be kept in a safe location in the Gondar University hospital . It will be available in an anomymous manner upon request and after deidentification. Study Protocol It will be available in an anomymous manner upon request from January 2023 to December 2032 It will be accessible to any researchers or reveiwer who might review the data and perhaps perform some new data analysis, the decision will be in the hands of the Principal investigator and colleagues in Gondar University, plus health and ethical authorities following legislation.
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