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Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria
Bu çalışma, komplike olmayan sıtma (uncomplicated malaria) tedavisinde Maytenus Senegalensis adlı bitkisel ürünün güvenliliğini ve etkinliğini incelemektedir. 18-45 yaş arası sağlıklı erkekler ile mikroskopla doğrulanmış P. falciparum sıtması olan erkekler katılabilmektedir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Group 1 Inclusion Criteria: * Healthy males based on clinical and laboratory findings * Aged from 18 to 45 years * Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2. * Long-term (at least one year) or permanent residence in the Bagamoyo district or nearby districts. * Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study. * Willingness to be attended to by a study clinician and take all necessary medications prescribed during the study period * Agreement to provide contact information of a third-party household member or close friend to study team * Availability through mobile phone 24 hours during the entire study period * Agreement not to participate in another clinical trial during the study period * Agreement not to donate blood during the study period * Able and willing to complete the study visit schedule over the study follow up period, including the hospitalizations required for protocol compliance * Willingness to undergo HIV, hepatitis B (HBV) and hepatitis C (HCV) tests * Able to demonstrate their understanding of the study by responding correctly to 10 out of 10 true/false statements (in a maximum of two attempts for those who failed to respond correctly to all true/false statements in the first attempt) * Signed written informed consent, in accordance with local practice * Free from malaria parasitaemia by blood smear at enrolment Exclusion Criteria: * Previous receipt of an investigational malaria drug in the last 5 years * Participation in any other clinical study involving investigational medicinal products within 30 days prior to the onset of the study or during the study period * History of arrhythmias or prolonged QT-interval or another cardiac disease, or clinically significant abnormalities in electrocardiogram (ECG) at screening * Positive family history in a 1st or 2nd-degree relative for the cardiac disease at age \<50 years old * A history of psychiatric disease * Suffering from any chronic illness including; diabetes mellitus, cancer or HIV/AIDS * Any confirmed or suspected immunosuppressive or immune-deficient condition, including asplenia * History of drug or alcohol abuse interfering with normal social function * The use of chronic immunosuppressive drugs or other immune-modifying drugs within three months of study onset except inhaled and topical corticosteroids. * Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis * Positive HIV, hepatitis B virus or hepatitis C virus tests * Suspected of having clinically active TB by history or physical examination with positive QuantiFERON-TB Gold Test In-Tube assay * Symptoms, physical signs and laboratory values suggestive of systemic disorders including renal, hepatic, blood, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric, and other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers. * Any medical, social condition, or occupational reason that, in the judgment of the study clinician, is a contraindication to protocol participation or impairs the volunteer's ability to give informed consent, increases the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data Group 2 Inclusion Criteria: * Male adults aged from 18 to 45 years * Ability to swallow oral medication * Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2. * Uncomplicated malaria, with microscopically confirmed mono-infection by P. falciparum (parasitaemia ≥1.000/ μL and \<200,000/ μL). * History of fever anytime during the preceding 24 hours or presence of fever (axillary temperature ≥37.5 °C or rectal ≥38.0 °C). * Ability to understand the nature of the trial * Ability and willingness to comply with the protocol for the duration of the study, study visit schedule and to provide informed consent from. * Stable residence in the study area during the two months after recruitment. Exclusion Criteria: * A history of antimalarial drug use such as Amodiaquine, Chloroquine, Quinine or lumefantrine-based compounds within the previous 6 weeks, with Piperaquine-based compound, or Mefloquine, or Sulphadoxine/pyrimethamine (SP) within the previous 3 months and with Halofantrine within the 30 days prior to screening. * Any other antimalarial drug or antibiotics use with antimalarial activity (including cotrimoxazole) and any herbal products, within the 7 days prior to screening. * Presence of any febrile condition due to severe diseases other than malaria (e.g. measles, pneumonia, typhoid fever, UTI, meningitis * Presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO * Known hypersensitivity to the artemisinin-based therapy. * History of the relevant clinical allergic reaction of any origin. * Known moderate/ severe renal or liver insufficiency. * Evidence of clinically relevant hematological, pulmonary, metabolic-endocrine, neurological, urogenital diseases as judged by the study clinician. * Suffering from any chronic illness including; cancer or HIV/AIDS or hepatitis B virus (HBV) or HCV infection * Previous admission for, or evidence of symptomatic cardiac arrhythmias or with clinically relevant bradycardia at screening (bpm \< 40). * Family history of sudden death, or known congenital prolongation of the QT interval, or any clinical condition known to prolong the QT interval. * Any other ECG abnormality that requires urgent management. * Gastrointestinal dysfunction that could alter absorption or motility (i.e. malabsorption syndromes, intestinal sub occlusion or previous major gastrointestinal surgery). * Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis * Severe anemia (Hb \< 7.9 g/dL). * Participation in any investigational drug study during the 42 days prior to screening