Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-25 @ 7:05 PM
Study NCT ID:
NCT04944966
Status:
COMPLETED
Last Update Posted:
2023-07-18
First Post:
2021-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Maytenus Senegalensis for the Treatment of Uncomplicated Malaria
Sponsor:
Ifakara Health Institute
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MALHERBAL
Brief 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 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: