Efficacy and safety of Mojeaga remedy in combination with conventional oral iron therapy for correcting anemia in obstetric population: A phase II randomized pilot clinical trial.

BACKGROUND: To our knowledge, there is no prior randomized trial on the efficacy of Mojeaga remedy (a special blend of Alchornea cordifolia, Pennisetum glaucum and Sorghum bicolor extracts) when co-administered with standard-of-care for correction of anemia in obstetrics practice. This study determined the efficacy, safety and tolerability of Mojeaga as adjunct to conventional oral iron therapy for correction of anemia in obstetric population. METHODS: A pilot open-label randomized clinical trial. Participants with confirmed diagnosis of anemia in three tertiary hospitals in Nigeria were studied. Eligible participants were randomized 1:1 to either Mojeaga syrups 50 mls (200mg/50mls) administered three times daily in conjunction with conventional iron therapy (Mojeaga group) for 2 weeks or conventional iron therapy alone without Mojeaga (standard-of-care group) for 2 weeks. Repeat hematocrit level were done 2 weeks post-initial therapy. Primary outcome measures were changes in hematocrit level and median hematocrit level at two weeks post therapy. Maternal adverse events and neonatal outcomes (birth anomalies, low birthweight, preterm rupture of membranes and preterm labor) were considered the safety outcome measures. Analysis was by intention-to-treat. RESULTS: Ninety five participants were enrolled and randomly assigned to the Mojeaga group (n = 48) or standard-of-care group (n = 47). The baseline socio-demographic and clinical characteristics of the study participants were similar. At two weeks follow-up the median rise in hematocrit values from baseline (10.00±7.00% vs 6.00±4.00%;p<0.001) and median hematocrit values (31.00±2.00% vs 27.00±3.00%;p<0.001) were significantly higher in the Mojeaga group. There were no treatment-related serious adverse events, congenital anomalies or deaths in the Mojeaga group and incidence of other neonatal outcomes were similar (p>0.05). CONCLUSION: Mojeaga represents a new adjuvants for standard-of-care option for patients with anemia. Mojeaga remedy is safe for treating anemia during pregnancy and puerperium without increasing the incidence of congenital anomalies, or adverse neonatal outcomes. CLINICAL TRIAL REGISTRATION: www.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).

Herbal supplements as treatment options for COVID-19: A call for clinical development of herbal supplements for emerging and re-emerging viral threats in Sub-Saharan Africa.

The advent of Corona virus Disease 2019 (COVID-19) distorted health systems of many countries. Efforts have been made to either develop new treatment solutions such as vaccines or repurpose previously adopted drugs. Challenges in accessing available treatment, inadequate, non-existent, or overstretched healthcare facilities, long COVID disease, cultural practices and beliefs about vaccination, vaccine hesitancy, availability, accessibility and perceived safety of herbal supplements seem to be major factors propelling individuals to use herbal supplements. Published reports advocating for clinical development of herbal supplements for COVID-19 and other emerging and re-emerging viral diseases are sparse. This paper aims to review the pathogenesis of COVID-19, use of herbal products during the pandemic and make case for clinical development of herbal supplements through the adoption of modern and acceptable technologies and research processes. This was a scoping review. Database searches of Google Scholar, PubMed and ResearchGate among others were performed using related keywords to identify relevant journals and lists of primary articles. Clinical trial databases:-Clinicaltrial.gov, Pan African Clinical Trial Registry (PACTR) and WHO international clinical trial registry (ICTRP) were reviewed to extract data. The use of herbal supplements during COVID-19 was not only peculiar to individuals living in Sub-Saharan Africa, but a global practice. Herbal supplements recommended to manage COVID-19 have not been validated using clinical trials. Available data showed that the number of herbal supplements undergoing clinical trial for COVID-19 indication in Africa was low. The availability of medicinal plants in Sub-Saharan Africa if well explored has great potentials to address various emerging and re-emerging viral diseases confronting the region. The economic potential of clinically validated herbal supplements are huge, and tapping into this opportunity created by preference of population to herbal supplement could increase export of herbal supplement and gross domestic product (GDP) of respective countries in Africa.

Potential antimalarial activity of Coccinia barteri leaf extract and solvent fractions against Plasmodium berghei infected mice.

ETHNOPHARMACOLOGICAL RELEVANCE: Coccinia barteri (Hook. F.) is traditional used in Southeast of Nigeria in management of fever. This study aimed to evaluate the antimalarial activities of hydro-methanol crude extract and solvent fractions of Coccinia barteri leaf. MATERIALS AND METHODS: Two animal models employed for the study were, 4-day suppressive and curative assays against chloroquine sensitive Plasmodium berghei NK65. Level of parasitaemia, mean survival time (MST), anal temperature and weight loss were measured to assess antimalarial efficacy of the extract/fractions. Chloroquine (10 mg kg-1) was used as positive control. Chemo-profile of extract was evaluated using GC-MS, HPLC techniques and standard phytochemical analysis. Preliminary toxicity test was done using modified Lorke's method. RESULTS: The crude extract (100-400 mg kg-1) and solvent fractions (20-80 mg kg-1) demonstrated antimalarial activity in both models compared to controls. Semi purified fractions of the extract produced stronger percentage chemosuppression and inhibition of parasite. The % inhibition of the fractions, hexane, chloroform, ethyl acetate and aqueous at 80 mg kg-1 were 96.0 0, 95.29, 89.86 and 96.00% respectively on day 8 (D8). While on D14, 100% parasite clearance, indicating cure was obtained for hexane, chloroform and aqueous fraction treatment groups, no death occurred in these groups. Ethyl acetate fraction treated groups lived longer but were not fully protected. Some marker compounds were identified. CONCLUSIONS: These results support the use of C. barteri as malaria remedy and potential source of antimalarial templates. Long acting parasitaemia reduction effect indicates its possible combination potential in poly-herbal combination therapy.

Elevated prenatal methylmercury exposure in Nigeria: evidence from maternal and cord blood.

Methylmercury is a neurodevelopmental toxicant that is globally distributed though little is known about prenatal exposures in sub-Saharan Africa. The objective of the current study was to measure total mercury levels in cord blood and maternal blood from 95 mother-newborn pairs recruited from hospitals in Nnewi, Nigeria. The secondary aims of the study were to explore if demographic and dietary factors were associated with blood mercury levels, and to explore if mercury levels were associated with any self-reported health outcome and childbirth outcome. Maternal blood mercury levels averaged 3.6 µg L(-1) and ranged from 1.1 µg L(-1) to 9.5 µg L(-1). Cord blood mercury averaged 5.1 µg L(-1) and ranged from 1.2 µg L(-1) to 10.6 µg L(-1). The mean ratio of mercury in paired cord blood to maternal blood was 1.5 and it ranged from 0.4 to 3.2. Mercury in maternal and cord blood were significantly correlated (r=0.471). More than one-third of mothers reported eating fish at least once per day, and a weak (p=0.08) fish consumption-related increase in blood mercury was found. Cord blood mercury was positively and significantly associated with birth weight and length, and head and chest circumference. Mercury levels in 36% of the participants exceeded the biomonitoring guideline associated with the United States Environmental Protection Agency (U.S. EPA) reference dose for mercury. The study shows that pregnant women and their newborns are exposed to methylmercury and that their exposures are higher compared to general populations sampled from other regions of the world.

Towards prenatal biomonitoring in eastern Nigeria: assessing lead levels and anthropometric parameters of newborns.

The purpose of this study is to measure maternal blood lead level (BLL) and cord BLL in Nigeria and to compare Nigerian data with other data. We investigated the association among maternal and cord BLLs, and some anthropometric parameters of their babies. BLL was measured in the umbilical and maternal blood samples (using inductively coupled plasma / mass spectrometry (ICP-MS)) of 119 women who delivered at three different hospitals in Nnewi, South Eastern Nigeria. Anthropometric variables of the babies (head circumference, abdominal circumference, birth weight, birth length, crown rump length) were measured. Lead was detected at >10 µg/l in 10.9 percent of the maternal and 3.4 percent of the cord blood samples. The maternal BLL was 6.19 ± 2.77(mean ± SD) µg/dl while cord BLL was 4.75 ± 2.59(mean ± SD) µg/dl. With the exception of cord BLL and crown rump length positive correlation (R=0.204, P=0.026), neither the maternal nor the cord BLL showed any significant association with any of the children's anthropometric parameters.

Heavy metal hazards of sachet water in Nigeria.

The authors assessed sachet water samples sold in Eastern Nigeria. Using an atomic absorption spectrophotometer, they analyzed levels of lead, cadmium, copper, and nickel. They also analyzed other parameters, such as nitrates, sulfates, chlorides, salinity, total hardness, biological oxygen demand, total dissolved solids, and pH level. Lead levels ranged from 0.002 to 0.036 mg/L in the samples; 5 samples (12.2%) had lead levels above the maximum contaminant level (MCL; 0.015 mg/L). Lead was not detectable in 20 samples (48.8%). Cadmium levels ranged from 0.002 to 0.036 mg/L and exceeded the MCL of 0.005 mg/L in 8 samples (19.5%); it was not detectable in 23 samples (56.1%). Copper was not detected in 2 (0.05%) of the samples. Its range was between 0.018 and 1.401 mg/L. Two samples (0.05%) had copper levels above the MCL (1.30 mg/L). Nickel levels ranged from 0.003 to 0.050 mg/l. The biological oxygen demand of the samples ranged from 3.20 to 36.80 mg/L. Other parameters were normal. The authors found that some of the sachet waters contain heavy metals, and consumers may be exposed to hazards.

Nephrotoxic actions of low-dose mercury in mice: protection by zinc.

The authors conducted this study to determine if very-low-dose (i.e., 4 ppm) mercury is nephrotoxic and, if so, whether the nephrotoxic actions of mercury in mice could be prevented by zinc intake. Animals were administered 4 ppm mercuric chloride and/or 800 ppm zinc chloride in their drinking water for 12 wk. The animals were sacrificed at the end of the exposure period, and their kidneys were excised, weighed, and processed for histological study. Both metals reduced significantly (p < .05) the absolute and relative kidney weights of the animals. Zinc-treated animals showed normal kidney histology that was comparable with that of the control. Mercury treatment produced necrosis and widening of the glomeruli, whereas a combination of both metals resulted in protection from the toxic effects, with most nephrons resembling the control. The results indicate that low-dose mercury exposure in mice kidney induces some degenerative effects, which are prevented by zinc.

Effects of rinbacin extract on rat kidney.

The aqueous leaf extract of rinbacin was tested for toxic effects on prepubertal rat kidneys following chronic administration. Two doses of rinbacin extract (26.25 g/l and 52.50 g/l) were administered in the rats' drinking water for 13 weeks, and various toxicologic indices tested. Histological study of the kidneys was also carried out at the expiration of the test period. Rinbacin at both dose sizes significantly (p<0.05) increased the absolute and relative kidney weights. Also the serum HCO3- level was significantly (p<0.05) increased, while the serum K+ level was decreased significantly at both dose levels. Only the high dose significantly (p<0.05) increased the serum urea level of the rats. Histological study showed that rinbacin at both dose sizes caused renal pathologic changes, which included necrosis and cellular infiltration of glomeruli and epithelia of the tubules. The effects were less marked in the low dose than the high dose group. Chronic administration of rinbacin extract induces nephrotoxicity in young rats.

Testicular toxicity of rinbacin in rats.

Rinbacin is a local Nigerian herbal remedy. The effects of rinbacin on testicular histology were studied in prepubertal rats. Sexually immature male rats, divided into seven per group, were given rinbacin in drinking waters at 0, 26.25 g/l, or 52.50 g/l for 13 weeks, after which the animals were killed and testes excised, weighed, and processed for histologic study. The epididymal sperm number (ESN) was determined. There were no significant effects of either the low or high doses of rinbacin on fluid intake, body weight, testicular weight, and testis-body weight ratio. There was, however, a significant (p<0.05) decrease in the ESN of animals at both doses of rinbacin. Histologic examination of the testes indicated that the high dose of rinbacin induced significant degenerative changes, while the low dose had only a mild effect on testicular histology. Rinbacin decreases the ESN and causes degenerative lesions, especially at the high dose, in prepubertal rats.