MalariaPhase 2MALHERBALNCT04944966
Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria
A Phase 2 study testing Maytenus Senegalensis in people with Malaria, run by Ifakara Health Institute at 1 site in Tanzania.
Trial summary
Antimalarial Herbal medicine known as Maytenus senegalensis will be evaluated for its safety, tolerability and efficacy among Tanzanian male adults aged 18 to 45 years. The first primary objective is to assess the safety and tolerability of malaria herbal remedy of Maytenus senegalensis among healthy male adults aged… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Maytenus Senegalensis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTanzania
- Study dates
- 2 Jun 2021to 25 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
- 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.
Who cannot join
- 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
Show all 31Show fewer
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria Episodes in Adult Patients as Compared to Artemether-lumefantrine
Antimalarial Herbal medicine known as Maytenus senegalensis will be evaluated for its safety, tolerability and efficacy among Tanzanian male adults aged 18 to 45 years. The first primary objective is to assess the safety and tolerability of malaria herbal remedy of Maytenus senegalensis among healthy male adults aged 18 to 45 years in Tanzania. And the second objective is to evaluate the safety, tolerability as well as efficacy of malaria herbal remedy Maytenus senegalensis (MALHERBAL) for the treatment of Tanzanian adults aged 18 to 45 years with uncomplicated malaria compared to Artemether-lumefantrine.
Read the detailed description
The herbal medicine (Maytenus senegalensis) has been scientifically investigated for acute toxicity in vitro and antiplasmodial activity both in vitro and in vivo where it showed strong antimalarial activity. However, to our knowledge, no antimalarial studies have been performed on this herbal medicine in standardized clinical settings.
The study will contain two treatment groups. Group 1 will have 12 healthy male adults aged 18 to 45 years who will be given the malaria herbal remedy (Maytenus senegalensis) and followed up for safety for 56 days. The subgroup 1a will be the first group to be enrolled in the study and given Malaria herbal remedy. The safety assessment of this group will be done in 7 days after the first treatment. If there will be no major safety concern per-protocol among participants of group 1a, the subgroup 1b participants will be enrolled in the study and given Malaria herbal remedy. The safety assessment of this subgroup 1b will be done 7 days after the first treatment. If there will be no major safety concern per-protocol among participants of group 1b, the subgroup 1c participants will be enrolled in the study and given Malaria herbal remedy. The safety assessment of this subgroup 1c will be done 7 days after the first treatment. If there will be no major safety concern per-protocol among participants of group 1c, the subgroup 1d participants will be enrolled in the study and given Malaria herbal remedy. The decision to proceed from G1 to the enrolment of G 2 participants will be determined by pre-specified "go or no go" criteria.
Study group 2 will comprise two subgroups of male Adults aged 18 to 45 years with uncomplicated malaria. The first is study group 2a of 52 uncomplicated malaria patients who will be treated with the malaria herbal remedy (Maytenus senegalensis) while G2b of 52 uncomplicated malaria patients will be treated with Artemether-lumefantrine. Patients will be followed up for 56 days. In the presence of failure for either the herbal remedy and Artemether-lumefantrine and Early Treatment Failure criteria met, the rescue treatment will be used.
The purpose of utilizing Group 1 participants is to assess the safety and tolerability of Maytenus senegalensis and proof of the concept that the herbal product is safe for the human subject. Therefore, the decision to proceed to Group 2 intervention for patients with naturally acquired malaria will be subjected to pre-specified "go or no go" criteria. These criteria will be based on safety data obtained from the sentinel group of 12 participants on day 28 after the first treatment and will be reviewed by an independent safety monitoring committee (SMC) appointed for this study. If one of the following criteria will be met, the study will not enroll the remaining G2 participants: (i)Any SAE related to the antimalarial herbal remedy (ii) ≥50% of the participants experienced a Grade 3 AR persisting at Grade 3 for > 48 hours during the 14 follow-up days.
- Conditions
- Malaria
- Being tested
- Maytenus Senegalensis
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maytenus SenegalensisDrug
Also called Artemether-lumefantrine
- Maytenus senegalensis (Malherbal) has a very long history of safe medicinal use in Africa in adult as well as infants and children. It will be administered orally at a dose of 800mg 8 hourly for 4 days.
- Artemether 20mg/lumefantrine 120mg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | • Experimental: Group 1a: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 400mg once a day to test its safety and tolerability.
Interventions:
o Drugs: Maytenus senegalensis
• Experimental: Group 1b: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 600mg once a day to test its safety and tolerability.
Interventions:
o Drugs: Maytenus senegalensis
• Experimental: Group 1c: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 800mg for 8 hourly for 4 days to test its safety and tolerability.
Interventions:
o Drugs: Maytenus senegalensis
• Experimental: Group 1d: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 800mg for 8 hourly for 4 days to test its safety and tolerability.
Interventions:
o Drugs: Maytenus senegalensis Receives: Drug: Maytenus Senegalensis |
| Group 2a | Experimental | Group 2a: n=52, Adults aged 18 to 45 years diagnosed with natural acquired uncomplicated malaria will be treated with Maytenus senegalensis.
Patients will be treated with Maytenus senegalensis administered orally at an estimated dose of 800mg for 8 hourly for 4 days.
Curative efficacy will be assessed by measure the portion of patients with Early Treatment Failure (ETF), Asexual parasite clearance time (PCT) and adequate Clinical and Parasitological Response (ACPR) for treatment at 28 days and 56 days after PCR correction of reinfection (ACPR 28 and 56 after PCR correction of reinfection
Interventions:
o Drugs: Maytenus senegalensis Receives: Drug: Maytenus Senegalensis |
| Group 2b | Active comparator | Group 2a: n=52, Adults aged 18 to 45 years diagnosed with natural acquired uncomplicated malaria will be treated with Artemether-lumefantrine Patients will be treated with Artemether 20mg/lumefantrine 120mg administered orally by a six-dose regimen over 3 days.
Curative efficacy will be assessed by measure the portion of patients with Early Treatment Failure (ETF), Asexual parasite clearance time (PCT) and adequate Clinical and Parasitological Response (ACPR) for treatment at 28 days and 56 days after PCR correction of reinfection (ACPR 28 and 56 after PCR correction of reinfection
Interventions:
o Drugs: Artemether 20mg/lumefantrine 120mg Receives: Drug: Maytenus Senegalensis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinical significance abnormal values in hematology parameters during the follow up period of 28 days for all participants of group 1 and 2.
Blood samples will be collected for the analysis of hematology parameters including Red cell blood count (RBC), hemoglobin (HBG), platelets (PLT), white blood cell count (WBC) with differential (neutrophil (NEUT), lymphocyte (LYMPH), and eosinophil (EO)) counts. Blood sample will be collected at Day 0(Baseline), Day 3, day 7, Day 14 and Day 28 Clinical significance abnormal values hematology parameter will be determined by adapted FDA Toxicity Grading Scale.
Measured: up period of 28 days
Number of participants with clinical significance abnormal values in biochemistry parameters during the follow up period of 28 days for all participants of group 1 and 2.
Blood samples will be collected for the analysis of biochemistry parameters including ASAT, bilirubin total and creatinine. Blood sample will be collected at Day 0(Baseline), Day 3, day 7, Day 14 and Day 28. Clinical significance abnormal values of Biochemistry parameters will be determined by adapted FDA Toxicity Grading Scale.
Measured: up period of 28
Number of participants with significant changes in vital signs comparing to baseline during the follow up period of 28 days for all participants of group 1 and 2.
Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Assessments were completed at Day 0 (Baseline), Day 1 up to Day 7, Day 14, and Day 28. We be reviewed using locally prepared normal range for vital sign
Measured: up period of 28
Number of AEs during the follow up period of 28 days for all participants of group 1 and 2
An Adverse Event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on all participants who received at least one dose of study treatment.
Measured: up period of 28
Number of SAEs during the follow up period of 56 days for all participants of group 1 and 2
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, other situations and is associated with liver injury or impaired liver function. The analysis was performed on all participants who received at least one dose of study treatment.
Measured: Up period of 56
Number of participants of group 2 with Early Treatment Failure (ETF),
Development of danger signs or severe malaria on Day 1, Day 2 or Day 3 in the presence of parasitaemia, parasitaemia on Day 2 higher than on Day 0, irrespective of axillary temperature, parasitaemia on Day 3 with axillary temperature ≥ 37.5 ºC and parasitaemia on Day 3 ≥ 25% of count on day 0.
Measured: Day 1 up to 3
Number of participants of group 2 with Late Treatment Failure (LTF)
Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitaemia; without previously meeting any of the criteria of Early Treatment Failure; Presence of parasitemia + axillary temperature ≥37.5°C on any day from Day 4 to Day 28, without previously meeting any criteria of ETF.
Measured: Day 4 up to 28
Number of participants of group 2 with Late parasitology failure (LPF)
Presence of parasitemia on any day from D7 to D28 + axillary temperature <37.5°C, without previously meeting any of the criteria of ETF
Measured: Day 7-28
Secondary outcomes (1)
Number of participants of group 2 with Adequate Clinical and Parasitological Response (ACPR)
Absence of parasitaemia on day 28 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start2 Jun 2021
- Primary completion25 Sep 2022
- Study completion25 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ifakara Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Muhimbili University of Health and Allied Sciences, National Institute for Medical Research, Tanzania
- Responsible party
- Sponsor
- Investigators
- Kamaka Kassim, BscN,MPH, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944966
- Sponsor's protocol ID
- MALHERBAL
- Acronym
- MALHERBAL
- Status last verified
- Jul 2023
- First submitted
- 16 May 2021
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kassimu KR, Ali AM, Omolo JJ, Mdemu A, Machumi F, Ngasala B. The effect of an anti-malarial herbal remedy, Maytenus senegalensis, on electrocardiograms of healthy Tanzanian volunteers. Malar J. 2024 Apr 12;23(1):103. doi: 10.1186/s12936-024-04935-w.
PubMed 38609987
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria Episodes in Adult Patients as Compared to Artemether-lumefantrine
- ClinicalTrials.gov ID
- NCT04944966
- Acronym / sponsor ID
- MALHERBAL / MALHERBAL
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ifakara Health InstituteUniversity, hospital or other
- Collaborators
- Swiss Tropical & Public Health Institute, Muhimbili University of Health and Allied Sciences, National Institute for Medical Research, Tanzania
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 25 Sep 2022 (actual)
- Study completion
- 25 Sep 2022 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antimalarial Herbal medicine known as Maytenus senegalensis will be evaluated for its safety, tolerability and efficacy among Tanzanian male adults aged 18 to 45 years. The first primary objective is to assess the safety and tolerability of malaria herbal remedy of Maytenus senegalensis among healthy male adults aged 18 to 45 years in Tanzania. And the second objective is to evaluate the safety, tolerability as well as efficacy of malaria herbal remedy Maytenus senegalensis (MALHERBAL) for the treatment of Tanzanian adults aged 18 to 45 years with uncomplicated malaria compared to Artemether-lumefantrine.
Detailed description
The herbal medicine (Maytenus senegalensis) has been scientifically investigated for acute toxicity in vitro and antiplasmodial activity both in vitro and in vivo where it showed strong antimalarial activity. However, to our knowledge, no antimalarial studies have been performed on this herbal medicine in standardized clinical settings.
The study will contain two treatment groups. Group 1 will have 12 healthy male adults aged 18 to 45 years who will be given the malaria herbal remedy (Maytenus senegalensis) and followed up for safety for 56 days. The subgroup 1a will be the first group to be enrolled in the study and given Malaria herbal remedy. The safety assessment of this group will be done in 7 days after the first treatment. If there will be no major safety concern per-protocol among participants of group 1a, the subgroup 1b participants will be enrolled in the study and given Malaria herbal remedy. The safety assessment of this subgroup 1b will be done 7 days after the first treatment. If there will be no major safety concern per-protocol among participants of group 1b, the subgroup 1c participants will be enrolled in the study and given Malaria herbal remedy. The safety assessment of this subgroup 1c will be done 7 days after the first treatment. If there will be no major safety concern per-protocol among participants of group 1c, the subgroup 1d participants will be enrolled in the study and given Malaria herbal remedy. The decision to proceed from G1 to the enrolment of G 2 participants will be determined by pre-specified "go or no go" criteria.
Study group 2 will comprise two subgroups of male Adults aged 18 to 45 years with uncomplicated malaria. The first is study group 2a of 52 uncomplicated malaria patients who will be treated with the malaria herbal remedy (Maytenus senegalensis) while G2b of 52 uncomplicated malaria patients will be treated with Artemether-lumefantrine. Patients will be followed up for 56 days. In the presence of failure for either the herbal remedy and Artemether-lumefantrine and Early Treatment Failure criteria met, the rescue treatment will be used.
The purpose of utilizing Group 1 participants is to assess the safety and tolerability of Maytenus senegalensis and proof of the concept that the herbal product is safe for the human subject. Therefore, the decision to proceed to Group 2 intervention for patients with naturally acquired malaria will be subjected to pre-specified "go or no go" criteria. These criteria will be based on safety data obtained from the sentinel group of 12 participants on day 28 after the first treatment and will be reviewed by an independent safety monitoring committee (SMC) appointed for this study. If one of the following criteria will be met, the study will not enroll the remaining G2 participants: (i)Any SAE related to the antimalarial herbal remedy (ii) ≥50% of the participants experienced a Grade 3 AR persisting at Grade 3 for > 48 hours during the 14 follow-up days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Maytenus Senegalensis• Experimental: Group 1a: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 400mg once a day to test its safety and tolerability. Interventions: o Drugs: Maytenus senegalensis • Experimental: Group 1b: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 600mg once a day to test its safety and tolerability. Interventions: o Drugs: Maytenus senegalensis • Experimental: Group 1c: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 800mg for 8 hourly for 4 days to test its safety and tolerability. Interventions: o Drugs: Maytenus senegalensis • Experimental: Group 1d: n=3, Healthy male participants will receive Maytenus senegalensis administered orally at an estimated dose of 800mg for 8 hourly for 4 days to test its safety and tolerability. Interventions: o Drugs: Maytenus senegalensis |
| Group 2a | Experimental | Drug: Maytenus SenegalensisGroup 2a: n=52, Adults aged 18 to 45 years diagnosed with natural acquired uncomplicated malaria will be treated with Maytenus senegalensis. Patients will be treated with Maytenus senegalensis administered orally at an estimated dose of 800mg for 8 hourly for 4 days. Curative efficacy will be assessed by measure the portion of patients with Early Treatment Failure (ETF), Asexual parasite clearance time (PCT) and adequate Clinical and Parasitological Response (ACPR) for treatment at 28 days and 56 days after PCR correction of reinfection (ACPR 28 and 56 after PCR correction of reinfection Interventions: o Drugs: Maytenus senegalensis |
| Group 2b | Active comparator | Drug: Maytenus SenegalensisGroup 2a: n=52, Adults aged 18 to 45 years diagnosed with natural acquired uncomplicated malaria will be treated with Artemether-lumefantrine Patients will be treated with Artemether 20mg/lumefantrine 120mg administered orally by a six-dose regimen over 3 days. Curative efficacy will be assessed by measure the portion of patients with Early Treatment Failure (ETF), Asexual parasite clearance time (PCT) and adequate Clinical and Parasitological Response (ACPR) for treatment at 28 days and 56 days after PCR correction of reinfection (ACPR 28 and 56 after PCR correction of reinfection Interventions: o Drugs: Artemether 20mg/lumefantrine 120mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maytenus SenegalensisAlso: Artemether-lumefantrine* Maytenus senegalensis (Malherbal) has a very long history of safe medicinal use in Africa in adult as well as infants and children. It will be administered orally at a dose of 800mg 8 hourly for 4 days. * Artemether 20mg/lumefantrine 120mg | Drug | Group 1, Group 2a, Group 2b |
Primary outcome
Number of participants with clinical significance abnormal values in hematology parameters during the follow up period of 28 days for all participants of group 1 and 2.
Time frame: up period of 28 days
Blood samples will be collected for the analysis of hematology parameters including Red cell blood count (RBC), hemoglobin (HBG), platelets (PLT), white blood cell count (WBC) with differential (neutrophil (NEUT), lymphocyte (LYMPH), and eosinophil (EO)) counts. Blood sample will be collected at Day 0(Baseline), Day 3, day 7, Day 14 and Day 28 Clinical significance abnormal values hematology parameter will be determined by adapted FDA Toxicity Grading Scale.
Number of participants with clinical significance abnormal values in biochemistry parameters during the follow up period of 28 days for all participants of group 1 and 2.
Time frame: up period of 28
Blood samples will be collected for the analysis of biochemistry parameters including ASAT, bilirubin total and creatinine. Blood sample will be collected at Day 0(Baseline), Day 3, day 7, Day 14 and Day 28. Clinical significance abnormal values of Biochemistry parameters will be determined by adapted FDA Toxicity Grading Scale.
Number of participants with significant changes in vital signs comparing to baseline during the follow up period of 28 days for all participants of group 1 and 2.
Time frame: up period of 28
Vital signs assessment included heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP). Assessments were completed at Day 0 (Baseline), Day 1 up to Day 7, Day 14, and Day 28. We be reviewed using locally prepared normal range for vital sign
Number of AEs during the follow up period of 28 days for all participants of group 1 and 2
Time frame: up period of 28
An Adverse Event is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The analysis was performed on all participants who received at least one dose of study treatment.
Number of SAEs during the follow up period of 56 days for all participants of group 1 and 2
Time frame: Up period of 56
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, other situations and is associated with liver injury or impaired liver function. The analysis was performed on all participants who received at least one dose of study treatment.
Number of participants of group 2 with Early Treatment Failure (ETF),
Time frame: Day 1 up to 3
Development of danger signs or severe malaria on Day 1, Day 2 or Day 3 in the presence of parasitaemia, parasitaemia on Day 2 higher than on Day 0, irrespective of axillary temperature, parasitaemia on Day 3 with axillary temperature ≥ 37.5 ºC and parasitaemia on Day 3 ≥ 25% of count on day 0.
Number of participants of group 2 with Late Treatment Failure (LTF)
Time frame: Day 4 up to 28
Development of danger signs or severe malaria on any day from day 4 to day 28 in the presence of parasitaemia; without previously meeting any of the criteria of Early Treatment Failure; Presence of parasitemia + axillary temperature ≥37.5°C on any day from Day 4 to Day 28, without previously meeting any criteria of ETF.
Number of participants of group 2 with Late parasitology failure (LPF)
Time frame: Day 7-28
Presence of parasitemia on any day from D7 to D28 + axillary temperature <37.5°C, without previously meeting any of the criteria of ETF
1 secondary outcome
Number of participants of group 2 with Adequate Clinical and Parasitological Response (ACPR)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 38609987Kassimu KR, Ali AM, Omolo JJ, Mdemu A, Machumi F, Ngasala B. The effect of an anti-malarial herbal remedy, Maytenus senegalensis, on electrocardiograms of healthy Tanzanian volunteers. Malar J. 2024 Apr 12;23(1):103. doi: 10.1186/s12936-024-04935-w.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamaka Kassim, BscN,MPH principal investigator
Ifakara Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Maytenus Senegalensis in people with Malaria, run by Ifakara Health Institute at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinical significance abnormal values in hematology parameters during the follow up period of 28 days for all participants of group 1 and 2. (time frame: up period of 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.