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.: PACTR201912921679091 Date of Approval: 27/12/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of Hypertension
Official scientific title Effects of food products (kinkeliba and bissap) in the treatment of uncomplicated hypertension: a multicenter clinical trial
Brief summary describing the background and objectives of the trial A randomized prospective trial that will include 240 uncomplicated hypertensive / common patients divided into five groups, each of which will receive one type of treatment: 2 products in 2 formulations (dry powder tablets and herbal tea according to traditional recipe) and 1 control group (conventional treatment, That is to say standard (Captopril 50 mg 2 / d in 1st intention)).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied hypertension
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/07/2017
Actual trial start date
Anticipated date of last follow up 29/03/2018
Actual Last follow-up date 31/08/2019
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 180
Recruitment status Completed
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 Computer generated table central randomisation by phone Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group bissap tablet 2* 200 mg bissap tablets, 6 months The tablets were produced by DIXA AG in St. Gallen containing 375 mg of compressed dried Bissap calyces 44
Experimental Group dried bissap calyces 1 cup filled with dried bissap calyces, 6 months The plant material for the brews was provided in bulk and the recipe was willingly left in a practical, home made form, because we wanted to study it along the principle of a pragmatic trial 44
Experimental Group kinkeliba tablets 2*375 mg kinkeliba tablets 6 months 375 mg kinkeliba tablets 44
Experimental Group kinkeliba leaves. 1 handful filled with dried kinkeliba leaves. 6 months dried kinkeliba leaves. 44
Control Group Captopril 2* captopril 50 mg in the morning. 6 months Captopril tablets 44 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Volunteer who agreed to participate in the study after signing a form of free and informed consent 2) Age between 20 and 70 years, 3) Systolic blood pressure between 140 and 179 mm Hg and diastolic blood pressure between 90 and 109 mm Hg, 4) Without clinical or biological signs of cardiovascular or renal hypertension (normal ECG, normal glomerular filtration rate and normal background of the eye), 5) Without any anti-hypertensive medication in progress (neither traditional nor modern). 1)Rapid increase in BP requiring urgent drug treatment 2) Woman in a state of pregnancy or nursing 3) Use of drugs or other treatments (other than those of the study) that can significantly and permanently affect blood pressure, 4) Any major reaction observed during the study and requiring specific management after medical advice. 20 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
Yes 02/03/2017 MOH Region StLouis
Ethics Committee Address
Street address City Postal code Country
BP 394 Ngallele Saint-Louis 46024 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction of blood pressure in a "plant" group equivalent to a "standard treatment" group and of at least 6 mmHg of systolic BP compared to the beginning of treatment, 1, 3 et 6 mois.
Secondary Outcome Achievement of target value <= 140 / <= 90 to. Side effects 1, 3 et 6 mois
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
UFR des Sciences de la Santé Route de Ngalléle Saint-Louis 234 Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Antenna foundation Av Grenade 24 Geneve 1207 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hop régional city st louis St Louis 234 Senegal Hospital
COLLABORATORS
Name Street address City Postal code Country
Sidy M Seck Route de Ngalléle St-Louis 234 Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sidy SEck sidy-mohammed.seck@ugb.edu.sn ++221 339617499 Route de Ngalléle
City Postal code Country Position/Affiliation
St-Louis 234 Senegal Prof
Role Name Email Phone Street address
Public Enquiries Sidy SEck sidy-mohammed.seck@ugb.edu.sn ++221 339617499 Route de Ngalléle
City Postal code Country Position/Affiliation
St-Louis 234 Senegal prof
Role Name Email Phone Street address
Scientific Enquiries Sidy SEck sidy-mohammed.Seck@ugb.edu.sn ++221 339617499 Route de Ngalliele
City Postal code Country Position/Affiliation
St-Louis 234 Senegal Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will underlye data reported in the published report (aftzer de-indentification Analytic Code,Clinical Study Report,Informed Consent Form,Study Protocol 3 months to 5 years after publication REsearchers with a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not yet available as results have not yet been published 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