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.: PACTR201907715482365 Date of Approval: 12/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Study on the use of Panax NotoGinseng LUOTAI in ischemic stroke in Senegal
Official scientific title Observational study on the use of Panax NotoGinseng LUOTAI in ischemic cerebrovascular accidents in Senegal
Brief summary describing the background and objectives of the trial Stroke is the leading cause of death and disability in the world. Although various units are in place for their management, the mortality associated with its aftermath remains dramatic. They represent an economic burden for the family and for the whole society knowledge and management of its complications are fundamental in the care. Since the advent of fibrinolysis and the creation of Neurovascular units, the management of ischemic strokes has largely evolved with a considerable improvement in life and functional prognosis. However, in our socio-economic conditions, diagnostic retardation, absence of Neurovascular centres, and lack of availability of fibrinolytics make the prognosis still bleak. Other therapies next to fibrinolysis are used to prevent recurrence and complications. This is the case for antiplatelet agents (aspirin-Clopidogrel) and statins. With this therapeutic approach aimed at improving the care of these patients, molecules whose active ingredients were extracted from the Chinese Pharmacopoeia showed their efficacy. Pharmacological studies have indicated that some herbal medicines in particular ginseng can improve coronary and cerebral revascularization, by exerting an antiaggregable platelet effect, improving circulation by reduction of blood stasis. They protect against ischemic reperfusion lesions and improve the tolerance of ischemic tissue to hypoxia. Increasingly, studies report, the use of these molecules in the emergency treatment of acute stroke. These study reports show that ginseng could increase the effectiveness of the management of strokes. Three recent studies on the use of ginseng have mentalised the improvement of neurological deficit during stroke with good tolerance. However, it has not yet been studied in the black African subject, the objective of this study is to evaluate the efficacy of this therapeutic DALYS in a Senegalese population in the hospital environment
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2019
Actual trial start date
Anticipated date of last follow up 29/08/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 152
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Controle 3 month amelioration of NIHSS and Bartel Score 76 Active-Treatment of Control Group
Experimental Group oral treatment with Luotai 3 month Luotai IV 200 mg /per day for 15 days and Luotai oral 200mg for 75 days 76
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ischemic stroke less than 7 days • Age inf 40 YO or sup 70YO • Stroke in the 3 last year • Refuse study • No possibility oral médication • Brain trauma Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 07/02/2019 Comite national dethique pour la recherche en sante NERS
Ethics Committee Address
Street address City Postal code Country
Fann Residence Rue Aime Cesaire Dakar 4024 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Recovery of Barthel score 90 days
Primary Outcome Recovery of NIHSS score 90 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Hopital Aristide Le Dantec Avenue Pasteur Dakar Dakar Senegal
Hopital regional Saint Louis Boulevard Abdoulaye Mar Diop Saint Louis Saint Louis Senegal
Hopital General Grand Yoff Route de la Gendarmerie Dakar Dakar Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
KPC Pharmaceuticals I66 Keyi Road, Kunming 650106, Yunnan 650106 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KPC I66 Keyi Road, Kunming 650106 Yunnan China Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
fatou aw Hopital Dantec Avenue Pasteur Dakar Senegal
Serigne Mor Beye Hopital regional saint Louis Saint Louis Senegal
Jean Batiste Mathieu Hopital regional Saint Louis Saint Louis Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adama Kane adama.kane@ugb.edu.sn +221776361067 Gaston Berger university Sanar
City Postal code Country Position/Affiliation
Saint Louis Senegal Vice dean of Medecine faculty cardiologist
Role Name Email Phone Street address
Public Enquiries Serigne Mor Beye serigne-mor.beye@ugb.edu.sn +221776776655 hopital rgional Saint Louis
City Postal code Country Position/Affiliation
Saint Louis Senegal Cardiologist Gaston Berger University
Role Name Email Phone Street address
Scientific Enquiries Fatou Aw fatoukineaw@yahoo.fr +221774220035 Avenue pasteur hopital Dantec
City Postal code Country Position/Affiliation
Dakar Senegal Cardiologist Cheikh Anta Diop University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article after deidentification (text tables, figures, and appendices) will be shared Clinical Study Report,Informed Consent Form Beginning immediately following publication and .ending 2 years following article publication. Researchers who provide a methodologically sound proposal may apply to access .Proposals should be directed to adama.kane@ugb.edu.sn to gain access, Data requestors will need to sign a data access agreement.
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