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.: PACTR202310608817705 Date of Approval: 19/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Grape seed in management of hypertension
Official scientific title Efficacy of Grape seed (Vitis vinifera) in the management of hypertension
Brief summary describing the background and objectives of the trial Hypertension (HTN) remains a global health problem associated with increased morbidity and mortality. Additionally, increasing prevalence has been recorded yearly, thus worsening the condition to unmanageable magnitudes. Oxidative stress in HTN patients leads to the progression of the disease further. This has led to reduced quality of life associated with macrovascular complications and renal failure. Reduction of blood pressure to recommended levels is the fundamental goal of HTN management. Pharmacological treatment has been the primary choice of treatment to achieve this. However, polyphenolic-containing compounds like Grape seed (Vitis vinifera) extract (GSE) are of benefit in the reduction of oxidative stress associated with increased blood pressure. Therefore this study aims to explore the efficacy of Grape seed (V. vinifera) extract (GSE) in the management of HTN. i. To determine the pharmacological management status of HTN patients ii. To assess the effect of Grape seed extract (GSE) on blood pressure control of HTN patient iii. To determine the effect of GSE on inflammatory markers (C-reactive protein) in HTN patient iv. To determine the effect of GSE on Kidney function post-intervention v. To assess the effect of GSE on cardiometabolic risk factors (HbA1c, obesity, lipid profile, body fat, visceral fat, basal metabolic rate) of HTN patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HTN STUDY
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/05/2023
Actual trial start date 29/10/2023
Anticipated date of last follow up 28/01/2024
Actual Last follow-up date 24/03/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL not Applicable
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Grape seed Extract GSE GROUP 100MG GRAPE SEED EXTRACT CONTAINING 90% POLYPHENOLS 3 MONTHS The participants in the experimental group will receive 100mg three time a day of grape seed extract containing 90% polyphenols making total dose 300mg per day for a period of three months 30
Control Group control group Cgroup 300 mg of placebo given in doses of 100 mg three times per day for 3 months 3 months The control group will be given a capsules of placebo 100mg three time a day for three months (The placebo will have vitamin c and calcium carbonate which are also contained in the packing of grape seed extract but will not have the grape seeds) 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients aged 18-80 years with hypertension and no other complication Those who consent to participate Those patients with hypertension aged 18-80 years with complications like renal failure and cardiovascular disorder Those eligible but do not consent to participate Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 17/08/2023 Jomo Kenyatta University of Agriculture and Technology Instittional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P. BOX 62000-00200, Nairobi Juja -kiambu Nairobi 00200 Kenya
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 17/08/2023 Jomo Kenyatta University of Agriculture and Technology Instittional Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
62000-Nairobi Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean change percentage systolic and diastolic blood pressure of the participants post-intervention after 3 months post intervention
Secondary Outcome Changes in mean fasting HbA1c of the participants post-intervention after 3 months post intervention
Secondary Outcome a. Change in mean body mass index (BMI) of the participant post-intervention b. Change in mean waist circumference of the participants post-intervention c. Change in mean waist-hip ratio of the participant post-intervention d. Change in mean weight for height ratio post-intervention e. Change in mean body fat and visceral fat post-intervention after 3 months post intervention
Secondary Outcome a. Change in mean triglyceride levels of the participants post-intervention b. Change in mean high-density lipoprotein cholesterol(HDL-C) levels of the participants post-intervention c. Change in mean low-density lipoprotein cholesterol (LDL-C) levels post-intervention d. Change in mean total cholesterol levels of the participants post-intervention after 3 months post intervention
Secondary Outcome a. Mean change in c-reactive protein post-intervention after 3 months post intervention
Secondary Outcome a. Mean change in sodium, potassium, and chloride post-intervention b. Mean change in urea, creatinine, and albumin post-intervention after 3 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gatundu Level 5 Hospital Gatundu kiambu Nairobi 01000 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
African ai Japan Project JICA KENYA 62000 JKUAT-JUJA NAIROBI 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor African ai Japan project JICA JKUAT PAUSTI 62000-JKUAT-JUJA NAIROBI 00200 Kenya Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Sharon chebet 62000-JKUAT JUJA NAIROBI 62000 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ANN THUITA WAMBUGU ann.thuita@jkuat.ac.ke +254721783766 62000-JKUAT JUJA
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya LECTURE
Role Name Email Phone Street address
Public Enquiries ANN THUITA WAMBUGU ann.thuita@jkuat.ac.ke +254721783766 62000-JKUAT JUJA
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya LECTURE
Role Name Email Phone Street address
Scientific Enquiries ANN THUITA WAMBUGU ann.thuita@jkuat.ac.ke +254721783766 62000-JKUAT JUJA
City Postal code Country Position/Affiliation
NAIROBI 00200 Kenya LECTURE
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share data for all the participants through publication 36 month after the end of the study Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 YEAR AFTER COMPLETION OF THE STUDY PUBLICATION
URL Results Available Results Summary Result Posting Date First Journal Publication Date
no publication yet 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