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

Effective care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi, Nigeria. Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria. Department of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria. Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria. Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria. Clinical Trial Division, Drug Evaluation and Research Directorate, NAFDAC, Lagos, Nigeria. Rural Community Clinical School, School of Medicine, Deakin University, Victoria, Australia. Department of Chemical Pathology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. Department of Pharmacology and Therapeutics, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria. Department of Haematology and Immunology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria. Measurement, Evaluation and Research Unit, Department of Educational Foundations, Nnamdi Azikiwe University, Awka, Nigeria. Department of Haematology, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria. Department of Internal Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria. Department of Nursing, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria. Department of Family Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria. Department of Ophthalmology, Nnamdi Azikiwe University, Awka, Nigeria. Department of Human Physiology, Nnamdi Azikiwe University, Nnewi, Anambra State, Nigeria. Department of Executive MPH, School of Public Health, University of Port-Harcourt, Port-Harcourt, Rivers State, Nigeria. Department of Radiology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria.

PloS one. 2023;18(5):e0285474
Abstract
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).
Study details
Language : eng
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