PMID- 31118966
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220408
IS  - 1741-427X (Print)
IS  - 1741-4288 (Electronic)
IS  - 1741-427X (Linking)
VI  - 2019
DP  - 2019
TI  - Short-Term Safety and Tolerability of an Antimalarial Herbal Medicine, CoBaT-Y017 
      in Healthy Volunteers.
PG  - 7610476
LID - 10.1155/2019/7610476 [doi]
LID - 7610476
AB  - BACKGROUND: Malaria is the most prevalent parasitic disease in Benin and the main 
      cause of morbidity and mortality. To fight this disease, a large proportion of 
      the population resorts to herbal drugs. However, for most of these herbal 
      preparations, no scientific evidence of their safety or efficacy has yet been 
      established. The aim of this study was to evaluate the short-term safety and 
      tolerability of  CoBaT-Y017 and collect some data on its antimalarial efficacy. 
      MATERIAL AND METHODS:   CoBaT-Y017 was formulated into syrup accommodated in 
      70 mL bottles. The trial involved a sample of 10 male volunteers, selected using 
      the Lot Quality Assurance Sampling (LQAS) method and declared apparently healthy 
      by a physician through clinical examination. During the baseline analysis, two 
      cases of parasitaemia were detected. The volunteers were hospitalized for 5 days 
      and orally given 35 mL of  CoBaT-Y017 diluted in 1.5 L of mineral water, for four 
      consecutive days. Safety and tolerability were monitored clinically, 
      haematologically, biochemically, and parasitologically on days 0 to 5, 7, and 14. 
      Adverse events were recorded by self-reporting or by a physician through clinical 
      examinations and biological investigations. RESULTS: 60% of the volunteers 
      experienced no adverse events; appetite increase (40%) and drowsiness (20%) were 
      adverse events noted. There were no changes in physical characteristics or vital 
      signs and haematological and biochemical parameters. The two initial positive 
      cases of parasitaemia became negative 24 hours after administration. CONCLUSION: 
        CoBaT-Y017 presented a significant safety and tolerability in healthy 
      volunteers to allow its further development by starting a phase II clinical 
      study.
FAU - Noudjiegbe, Adrien N
AU  - Noudjiegbe AN
AUID- ORCID: 0000-0002-8429-803X
AD  - Faculty of Health Sciences, Laboratory of Pharmacology and Toxicology, University 
      of Abomey-Calavi, Benin.
AD  - Beninese Center of Scientific Research and Innovation, National Laboratory of 
      Narcotic and Toxicology, Benin.
FAU - Gnimassou, Adeline L
AU  - Gnimassou AL
AD  - Faculty of Health Sciences, Laboratory of Pharmacology and Toxicology, University 
      of Abomey-Calavi, Benin.
AD  - Beninese Center of Scientific Research and Innovation, National Laboratory of 
      Narcotic and Toxicology, Benin.
FAU - Gbenoudon, Judith S
AU  - Gbenoudon JS
AD  - Faculty of Sciences and Technic, Laboratory of Immunology of Infectious diseases 
      and Allergic, University of Abomey-Calavi, Benin.
FAU - Degbelo, Jean-Eudes
AU  - Degbelo JE
AD  - Teaching Hospital of Abomey-Calavi/So-Ava, Laboratory of Biomedical Analysis, 
      Benin.
FAU - Allabi, Aurel C E
AU  - Allabi ACE
AD  - Faculty of Health Sciences, Laboratory of Pharmacology and Toxicology, University 
      of Abomey-Calavi, Benin.
AD  - Beninese Center of Scientific Research and Innovation, National Laboratory of 
      Narcotic and Toxicology, Benin.
AD  - Service of medicine, Teaching Hospital of Abomey-Calavi/So-Ava, Benin.
LA  - eng
PT  - Journal Article
DEP - 20190421
PL  - United States
TA  - Evid Based Complement Alternat Med
JT  - Evidence-based complementary and alternative medicine : eCAM
JID - 101215021
PMC - PMC6500644
EDAT- 2019/05/24 06:00
MHDA- 2019/05/24 06:01
PMCR- 2019/04/21
CRDT- 2019/05/24 06:00
PHST- 2019/01/30 00:00 [received]
PHST- 2019/04/01 00:00 [revised]
PHST- 2019/04/14 00:00 [accepted]
PHST- 2019/05/24 06:00 [entrez]
PHST- 2019/05/24 06:00 [pubmed]
PHST- 2019/05/24 06:01 [medline]
PHST- 2019/04/21 00:00 [pmc-release]
AID - 10.1155/2019/7610476 [doi]
PST - epublish
SO  - Evid Based Complement Alternat Med. 2019 Apr 21;2019:7610476. doi: 
      10.1155/2019/7610476. eCollection 2019.