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.: PACTR202312830900344 Date of Approval: 07/12/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Outcome Of Hibiscus Sabdariffa (Zobo) And Hyphaene Thebaica ( Goriba) on High Blood Pressure Among Humans with High Blood Pressure In Murtala Muhammad Special Hospital Kano-North-Western Nigeria
Official scientific title Effect Of Hibiscus Sabdariffa (Zobo) And Hyphaene Thebaica ( Goriba) on Blood Pressure Among Hypertensive Patients In Murtala Muhammad Special Hospital Kano-North-Western Nigeria
Brief summary describing the background and objectives of the trial Recent studies showed that Hibiscus Sabdariffa lowers blood pressure as effectively as some standard anti-hypertensive drugs and has not been found to be associated with any side effects and interaction. Our objective in this study is to examine the anti-hypertensive effects of H. sabdariffa (hibiscus tea) and H. Thebaica (Goriba) consumption in humans. This is aimed at establishing the hypotensive effect of hibiscus sabdariffa (zobo) and hyphaenethebaica ( goriba) among patients with primary hypertension
Type of trial CCT
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 Treatment: Drugs
Anticipated trial start date 01/12/2023
Actual trial start date 04/12/2023
Anticipated date of last follow up 29/12/2023
Actual Last follow-up date 29/12/2023
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Recruiting
Publication URL Goggle scholar
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Medicinal plant 3.75g/240ml three times per day one month Experimental group will be administered with Hibiscus sabdariffa tea and H. Thebeica prepared by brewing containing 3.75 g H. sabdariffa and H. Thebeica) per 240 mL boiled water for 5 minutes.. The participants will be instructed to consume it three times a day for a period of one month, 30
Control Group Placebo 240ml of drinking water per day one month Placebo will take 14g of full cream peak milk /240mls of drinking water boiled for 5 minutes 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with Grade 1 high blood pressure Patient within the age range of 45 to 65 years Patient with Grade 1 high blood pressure without co-morbidity Patient with high blood pressure in Grade II and above Patient with high blood pressure with co-morbidity Patient with high blood pressure but with age range greater than 65 years Middle Aged: 45 Year(s)-64 Year(s) 45 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 26/10/2023 Kano State Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Poss Office Road,P.M.B ,3066, Kano Kano 7000224 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood pressure Base line and every week for one month
Secondary Outcome Systolic blood pressure, and Diastolic blood pressure Base line then weekly for one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Muhammad Specialist Hospital Kano Kofar Mata Road,Kano City Kano 700224 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tertiary Education Trust Fund No.6 Zambezi Cresecnt, off Aguiyi Ironsi Street Maitama Abuja Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tertiary Education Fund No. Zanzeba Crescent Off Aguiironsi, Maitama District Abuja Abuja Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adamu Dalhatu adamudalhatu206@gmail.com 2348039503072 Bayero University Kano
City Postal code Country Position/Affiliation
Kano 7000221 Nigeria Senior Lecturer Bayero University Kano
Role Name Email Phone Street address
Public Enquiries Bashir Kaka bkaka.pth@buk.edu.ng 23408028460237 Zaria Road
City Postal code Country Position/Affiliation
Kano 7000221 Nigeria Professor Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries Umar Yunusa dr.yumar@ccuk.edu.ng +2348038199802 Bayero University Kano
City Postal code Country Position/Affiliation
Kano 7000221 Nigeria Senior Lecturer Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD Link will be shared after completion of the trials Informed Consent Form Twelve month Results
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