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How Safe and Effective are the Two (2) Ghanaian Herbal Anti-malarial formulations Mist Nibima & Lucky Herbal Mixture for the treatment of malaria.

Clinical Efficacy and Safety of Mist Nibima & Lucky Herbal Mixture: Two (2) Ghanaian Herbal Anti-malarial Formulations.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202107733803271
Enrollment
75
Registered
2021-07-22
Start date
2021-07-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Interventions

Artemisinin based combination therapy Coartern
Lucky Herbal Mixture
Mist Nibima

Sponsors

Department of Biomedical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Ghana

Contacts

Public ContactELVIS OFORI AMEYAW OFORI AMEYAW

Dean School of pharmacy

eameyaw@ucc.edu.gh+233208286284

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026