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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202404830427101 Date of Registration: 24/04/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Zobo (Hibiscus sabdariffa) drink on blood pressure control among hypertensive patients attending Lagos State University Teaching Hospital, Lagos, Nigeria
Official scientific title A Randomized Controlled Trial on the effect of Red hibiscus drink (zobo drink) on blood pressure control among hypertensive patients attending the Lagos State University Teaching Hospital, Lagos, Nigeria
Brief summary describing the background and objectives of the trial Hypertension is the leading preventable cause of cardiovascular disease (CVD) resulting in mortality and morbidities from damage to the heart and blood vessels, kidneys, eyes and brain. Hypertension is a major cause of morbidity and mortality in Nigeria. Only 1 in 5 that is 21% of adults living with hypertension achieve control despite the use of antihypertensives. Side effects of antihypertensive medications, the rising cost of health care and pharmaceuticals have led to non-adherence and the search for alternative means of managing hypertension. Positive cultural beliefs and experiences among people and their traditions, make them more willing to trust and use herbal medications. Herbs such as garlic, onion, Chinese herbal teas, black and green tea, and Hibiscus sabdariffa otherwise known as sour tea have been reported to have some positive effects on blood pressure. This study aims to investigate the effect of hibiscus sabdariffa (Zobo) drink on blood pressure control in hypertensive patients in Lagos State University Teaching Hospital, Lagos, Nigeria, with a goal to improving the care of hypertension in Nigeria through cost-effective lifestyle measures. The specific objectives of the study are: 1. To evaluate the socioeconomic characteristics of respondents. 2. To determine the blood pressure control among study participants 3. To determine the lifestyle pattern of respondents. 4. To determine the effect of Zobo drink on blood pressure control among participants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/07/2024
Actual trial start date
Anticipated date of last follow up 30/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 81
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1 1.25g hibiscus clove ginger 100mls twice daily 13 weeks Group 1 will receive 2 servings/d (200 mL/d) of H. sabdariffa drink+clove+ginger for 13 weeks with standard treatment of blood pressure. The participants will then be seen the following week and thereafter followed up fortnightly for a period of three months (13 weeks). Their blood pressure will be measured at each follow-up visit following standard BP measuring procedure 27
Experimental Group Group 2 1.25g Hibiscus alone 100 mls twice daily 13 weeks Group 2 will receive 2 servings/d (200 mL/d) of H. sabdariffa only for 13 weeks with standard treatment of blood pressure. The participants will then be seen the following week and thereafter followed up fortnightly for a period of three months (13 weeks). Their blood pressure will be measured at each follow-up visit following standard BP measuring procedure 27
Control Group Group 3 placebo drink with dried artificial hibiscus flavour 100mls twice daily 13 weeks Group 3 will receive 2 servings/d (200 mL/d) of dried artificial hibiscus flavour with standard treatment of blood pressure for 13 weeks. The participants will then be seen the following week and thereafter followed up fortnightly for a period of three months (13 weeks). Their blood pressure will be measured at each follow-up visit following standard BP measuring procedure 27 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Newly diagnosed hypertensive patients with stage 1 hypertension (JNC-7 classification) 2. Stage 1 hypertensive patients who are yet to commence antihypertensive medications 3. Stage 1 hypertensive patients on anti-hypertensive medications 4. Adults aged 30 to 70 years 1. Stage 1 Hypertensive patients with co-morbidities such as Diabetes, Chronic Kidney Disease 2. Pregnant hypertensive patients 3. Those with history of reaction to Hibiscus 4. Those who refuse to participate Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 70 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
No 12/04/2024 Health Research Ethics Committee of LASUTH
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Way, GRA, Ikeja Lagos 101233 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood pressure control after 13vweeks 1 week after recruitment, then every 2 weeks for 13 weeks
Secondary Outcome To determine the lifestyle pattern of participants Every week through diet and exercise check-list
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1-5 Oba Akinjobi Way, GRA, Ikeja Lagos 101233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
OdunayeBadmus Sekinat 40, Olaniyi street, New Oko Oba, Agege Lagos Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OdunayeBadmus Sekinat 40, Olaniyi Street, New Oko, Oba, Agege Lagos Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Tijani Oseni Km 7 Auchi-Abuja Road Uzairue Nigeria
Eniola AfolabiObe House 15, Westville Estate, Lagos-Ibadan Expressway, Arepo Ogun Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sekinat OdunayeBadmus sekkynat50@yahoo.com +2348027628476 40, Olaniyi, Street, New Oko Oba, Agege
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant Family Physician Lagos State University Teaching Hospital Ikeja Lagos Nigeria
Role Name Email Phone Street address
Scientific Enquiries Tijani Oseni oseni.tijani@edouniversity.edu.ng +2348036281897 Edo State University, Km 7, Auchi-Abuja Road
City Postal code Country Position/Affiliation
Uzairue Nigeria Consultant Family Physician Edo State University Uzairue Nigeria
Role Name Email Phone Street address
Public Enquiries Eniola AfolabiObe eafolabiobe@gmail.com +2348033678683 House 15, Westville Estate, Lagos-Ibadan Expressway, Arepo
City Postal code Country Position/Affiliation
Ogun Nigeria Consultant Family Physician Lagos State University Teaching Hospital Lagos Nigeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with academic interest in Hypertension. Data shared will be de-identified, with no personal participant data. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party Informed Consent Form,Study Protocol Within 6 months of completing the trial Will be updated later
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