1. 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.
- Author
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Eleje GU, Ezebialu IU, Enebe JT, Ezeora NC, Ugwu EO, Ake ID, Nwankwo EU, Enyinna PK, Okoro CC, Asuoha CP, Oguejiofor CB, Obi E, Okafor CG, Ugwu AO, Eleje LI, Malachy DE, Ubammadu CE, Igbodike EP, Anikwe CC, Ajuba IC, Ufoaroh CU, Egeonu RO, Okafor LU, Enechukwu CI, Nweje SI, Anaedu OP, Ikpeze OZ, Okpala BC, Emeka EA, Nzeukwu CS, Aniedu IC, Chukwuka EC, Onwuegbuna AA, Ikwuka DC, Chigbo CG, Agbanu CM, Onwuka CI, Nwankwo ME, Nneji HC, Onyeukwu KA, Odugu BU, Nweze SO, Onyekpa IJ, Eze KC, Chukwurah SN, Ugboaja JO, and Ikechebelu JI
- Subjects
- Pregnancy, Infant, Newborn, Female, Humans, Iron adverse effects, Pilot Projects, Infant, Low Birth Weight, Obstetric Labor, Premature, Anemia chemically induced
- 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)., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Eleje et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
- Published
- 2023
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