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.: PACTR202107733803271 Date of Registration: 22/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title How Safe and Effective are the Two (2) Ghanaian Herbal Anti-malarial formulations Mist Nibima & Lucky Herbal Mixture for the treatment of malaria.
Official scientific title Clinical Efficacy and Safety of Mist Nibima & Lucky Herbal Mixture: Two (2) Ghanaian Herbal Anti-malarial Formulations.
Brief summary describing the background and objectives of the trial Herbal medicines though natural can pose serious health risks to the consumer if not processed, preserved, stored and administered in accordance to prescribed regulatory standards. In Ghana, the Food and Drugs Authority (FDA) is mandated to regulate the use of herbal products, though the guidelines for product registrations requires the provision of clinical evidence of efficacy, a limited number of herbal products have been evaluated and approved based on long term safety and clinical efficacy. The aim of the study is to evaluate the clinical efficacy and safety of two (2) Ghanaian herbal products: Mist Nibima & Lucky Herbal Mixture in the management of uncomplicated malaria. Our study design will be a multi-centre randomized control trial to be undertaken at five (5) study sites: herbal units of the Ewim Polyclinic and Nsawam Government Hospital, the Centre for Plant Medicine Research Clinic, Mampong-Akuapem, Kumasi South Hospital and the University of Cape Coast Hospital. The population for this study will be patients diagnosed and confirmed as having an uncomplicated malaria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/07/2021
Actual trial start date
Anticipated date of last follow up 20/02/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
UCCIRBCHAS202119 University of Cape Coast Institutional review Board
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 Artemisinin based combination therapy Coartern 80mg/480mg tablets 80mg/480mg tablets as single initial dose,80mg/480mg tablets again after 8 hours and then 80mg/480mg tablets-daily (morning and evening) for the following 2 days (total course of 24 tablets). The comparator drug will be the standard treatment of an Artemisinin based combination therapy. This intervention is the first line of treatment for uncomplicated malaria and generally available as an over-the-counter drug. 25 Active-Treatment of Control Group
Experimental Group Lucky Herbal Mixture dosage of 20ml three times daily for seven days. seven days. Lucky Herbal Mixture is also a Ghanaian herbal medicine registered with the FDA (Reg No: FDA/ HD.16-05187) and produced by the Lucky Herbal Industry. The product has the following plants as components: Enantia polycarpa, Adenia cissampeloides, Plumbago capensis, Tetrapleura tetraptera, Moringa oleifera 25
Experimental Group Mist Nibima dosage of 90mls in three divided doses a day will be administered for all subjects for seven days. Mist Nibima is an FDA (Reg No: FDB/HD.07-7096) approved treatment for the management of uncomplicated malaria. The product is manufactured by the Centre for Plant Medicine Research, Mampong-Akuapem and widely used as such across the country. This herbal product is formulated from the roots of the medicinal plant Cryptolepis sanguinolenta 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients to be included in this study will comprise: Male and females between the ages of 18-65 years. Such patients should also have a fever, defined as >37.5ºC, during the current illness, or history (within the last 48 hours) of fever. They should also have been diagnosed with malaria defined as blood parasitemia ≥ 200 parasites/µl. Participants should be able to communicate well with the investigator, comply with the requirements of the entire study, willing and/or able to return for a follow up and provide a written informed consent to participate as shown by a signature or thumbprint on the informed consent form. Patients accessed by the clinician to be at risk of developing severe malaria or those with the signs and symptoms including but not limited to: impaired consciousness or unrousable coma, prostration, i.e. generalized weakness so that the patient is unable walk or sit up without assistance, failure to feed, multiple convulsions, deep breathing, respiratory distress (acidotic breathing), circulatory collapse or shock, systolic blood pressure < 70 mm Hg in adults and < 50 mm Hg in children and clinical jaundice plus evidence of other vital organ dysfunction will all be excluded from the study. Also, to be excluded are pregnant and lactating mothers, infants and newborns. Individuals with chronic diseases of the liver, renal system, as well as those who are on any antimalarials or have done so within the last 2 weeks will be excluded from this study. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 14/06/2021 University of Cape Coast Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
University of Cape Coast Campus Cape Coast 233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary measure of efficacy of the treatments will be the total clearance of parasites by Day 5 after initiation of treatment. Participants who attain this outcome will be considered as having achieved a Complete cure. A definition of Partial efficacy will be applied when subjects are able to clear more than 75.0 % of initial parasite count by Day 5. Treatment failure will be said to have occurred when less than 75.0 % of the parasites have been cleared by Day 5. Day 5.
Secondary Outcome Other outcomes of interest will be the time taken for subject to attain the primary outcome (complete cure). Also, the response of fever to the treatments administered and the general improvement in related signs and symptoms will be measured. The absence of any untoward effects on the bodily organs as well as side effects (safety evaluation) will be considered as a secondary outcome. Day 5
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Herbal Units of the Ewim Polyclinic Ewim Cape Coast Ghana
Centre for Plant Medicine Research Mampong- Akuapem Mampong Akuapem Ghana
Herbal Unit Kumasi South Hospital Atonsu-Agogo Kumasi Ghana
University of Cape Coast Hospital UCC Cape Coast Ghana
Herbal Unit Nsawam Government Hospital Nsawam Nsawam Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded University of Cape Coast Cape Coast Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Biomedical Sciences University of Cape Coast Cape Coast Ghana University
COLLABORATORS
Name Street address City Postal code Country
Prof Elvis Ofori Ameyaw University of Cape Coast Cape Coast Ghana
Dr Alfred Ampomah Appiah Centre for Plant Medicine Research Mampong Akuapem Ghana
Dr. Kwesi Prah Thomford University of Cape Coast Cape Coast Ghana
Mr. Ronald Yeboah Centre for Plant Medicine Research Mampong Akuapem Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosemary Sorkpor doesorkpor@gmail.com +233206870838 University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Student
Role Name Email Phone Street address
Public Enquiries ELVIS OFORI AMEYAW OFORI AMEYAW eameyaw@ucc.edu.gh +233208286284 University of Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Dean School of pharmacy
Role Name Email Phone Street address
Scientific Enquiries ALFRED AMPOMAH APPIAH alfredampomahappiah@yahoo.com +233549335589 Mampong - Akuapem
City Postal code Country Position/Affiliation
Mampong Ghana Deputy Executive Director Head of research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data will be available for public access in raw and summarised form (i.e tables, figures, charts, etc). To ensure confidentiality, all participant data will be de-identified. Informed Consent Form,Study Protocol Individual patient data will be available for public access 9 months after the completion of the study. Access to raw data will also be available for a period of 24 months. Individuals and agencies requiring access to the trial data will have to apply to the clinical trial monitoring committee of the University of Cape Coast. This committee will judge the suitability of each appllication.
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