Assessment of the Short-Term Safety and Tolerability of a Quantified 80 % Ethanol Extract from the Stem Bark of<i>Nauclea pobeguinii</i>(PR 259 CT1) in Healthy Volunteers: A Clinical Phase I Study

Mesia, K.; Cimanga, Kanyanga; Tona, L.; Mampunza, M; Ntamabyaliro, Nsengi; Muanda, Tsobo; Muyembe, Tamfum; Totté, J.; Mets, Tony; Pieters, Luc; Vlietinck, A. J.

doi:10.1055/s-0030-1250134

Cited by 19 publications

(23 citation statements)

References 9 publications

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“…CoBaT-Y017 did not alter the patients' hepatic's functions. is hepatic profile observed with CoBaT-Y017 is similar to what was observed with the extract of Nauclea pobiguinii [17]. an antimalarial herbal medicine.…”

Section: Discussionsupporting

confidence: 80%

A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether‐Lumefantrine in Benin Subjects

Noudjiegbe

Alikekere

Tchehouenou

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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Background. Considering the promising results of Phase I clinical trials with herbal medicine CoBaT-Y017, a Phase II study was conducted with Plasmodium falciparum malaria-infected patients, for efficacy and safety evaluation of CoBaT-Y017 compared with Artemether-Lumefantrine used as a positive control. Methods. A single-blind randomized trial was conducted on 25 eligible males aged 18-40 years randomly assigned to two treatment groups: CoBaT-Y017 or Artemether-Lumefantrine. e first group received 35 ml of CoBaT-Y017 in 1.5 L mineral water administered daily for four consecutive days; the second group received oral Artemether-Lumefantrine, using WHO-recommended therapeutic dose regimens. For both drugs, efficacy for parasite clearance and safety were evaluated clinically, haematologically, and biochemically on days 1-4, 7, 14, 21, and 28. Clinical-and laboratoryadverse events (AEs) were recorded until day 28. Results. 13 and 12 patients were randomized into CoBaT-Y017 arm and Artemether-Lumefantrine arm, respectively. In all patients, parasitaemia was adequately neutralized with CoBaT-Y017 group patients' parasite clearance lagging slightly behind that of Artemether-Lumefantrine's group, but without a statistically significant difference (HR � 1.08, 95% CI 0.47-2.51, P � 0.85). Physical and laboratory examinations did not show any significant changes in vital signs, biochemical, and haematological parameters. In the Artemether-Lumefantrine arm, 100% (12/12) of patients experienced, at least, one adverse event versus 61.5% (8/13) in the CoBaT-Y017 arm. Conclusion. CoBaT-Y017 exhibited similar antimalarial efficacy against P. falciparum to that of Artemether-Lumefantrine, with good tolerability and safety.

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Section: Discussionsupporting

confidence: 80%

A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether‐Lumefantrine in Benin Subjects

Noudjiegbe

Alikekere

Tchehouenou

et al. 2020

Evidence-Based Complementary and Alternative Medicine

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“…It is also non-toxic: no acute toxicity was observed in mice after a single 2 g/kg oral dose, nor after 4 weekly doses (Mesia et al, 2010). Furthermore it is safe and effective against uncomplicated malaria in humans (Mesia et al, 2011;Mesia et al, 2012a;Mesia et al, 2012b). One of the active compounds is thought to be strictosamide.…”

Section: Familymentioning

confidence: 99%

Ethnobotanical study of plants used against malaria in Sélingué subdistrict, Mali

Diarra

Klooster

Togola

et al. 2015

Journal of Ethnopharmacology

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“…Not all of the trials named the herb that had been studied, but the herbs most commonly quoted were Artemisia annua (five trials) and Vernonia amygdalina (two trials). Only five trials (21%) had been published, [3][4][5][6][7] and only two of these in a peer-reviewed, MEDLINE Ò -listed journal. Only one had resulted in a product with an official marketing authorization: Niprisan for the prevention of crises in patients with sickle cell disorder.…”

Section: Resultsmentioning

confidence: 99%

Capacity for Clinical Research on Herbal Medicines in Africa

Willcox

Siegfried

Johnson

2012

The Journal of Alternative and Complementary Medicine

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An electronic survey was used to assess the training needs of clinical and public health researchers who have been involved, and/or plan to become involved, in clinical trials of herbal medicines in Africa. Over 90 researchers were contacted through pre-existing networks, of whom 58 (64%) responded, from 35 institutions in 14 African countries. Over half (57%) had already been involved in a clinical trial of an herbal medicine, and gave information about a total of 23 trials that have already been completed. Of these, only five had been published, and only one had resulted in a licensed product. Fifty-four (54) of the researchers were planning to conduct a clinical trial of an herbal medicine in the future, and gave information about 54 possible trials. Respondents outlined the following most commonly encountered difficulties when conducting clinical trials: resource constraints (including lack of funding, equipment, staff, and infrastructure); social acceptance of the clinical trial (including difficulty recruiting enough patients, poor rapport with traditional healers, and willingness of biomedical staff to be involved); herbal medicine supply (including insufficient cultivation, production, and quality control); lack of trained staff; and logistical issues in conducting trials. The topics in which researchers were least confident were Intellectual Property Rights issues, statistical issues, and issues related to Good Clinical Practice guidelines.

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Assessment of the Short-Term Safety and Tolerability of a Quantified 80 % Ethanol Extract from the Stem Bark ofNauclea pobeguinii(PR 259 CT1) in Healthy Volunteers: A Clinical Phase I Study

Cited by 19 publications

References 9 publications

A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether‐Lumefantrine in Benin Subjects

A Phase II Pilot Trial to Evaluate CoBaT-Y017 Safety and Efficacy against Uncomplicated Falciparum Malaria versus Artemether‐Lumefantrine in Benin Subjects

Ethnobotanical study of plants used against malaria in Sélingué subdistrict, Mali

Capacity for Clinical Research on Herbal Medicines in Africa

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