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.

Autor: Eleje GU; 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., Ezebialu IU; Department of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria., Enebe JT; Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria., Ezeora NC; Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria., Ugwu EO; Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria., Ake ID; Clinical Trial Division, Drug Evaluation and Research Directorate, NAFDAC, Lagos, Nigeria., Nwankwo EU; Rural Community Clinical School, School of Medicine, Deakin University, Victoria, Australia., Enyinna PK; Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria., Okoro CC; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Asuoha CP; Department of Chemical Pathology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria., Oguejiofor CB; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Obi E; Department of Pharmacology and Therapeutics, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria., Okafor CG; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Ugwu AO; Department of Haematology and Immunology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria., Eleje LI; Measurement, Evaluation and Research Unit, Department of Educational Foundations, Nnamdi Azikiwe University, Awka, Nigeria., Malachy DE; Effective care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi, Nigeria., Ubammadu CE; Effective care Research Unit, Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University, Nnewi, Nigeria., Igbodike EP; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Anikwe CC; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Ajuba IC; Department of Haematology, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria., Ufoaroh CU; Department of Internal Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria., Egeonu RO; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Okafor LU; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Enechukwu CI; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Nweje SI; Department of Nursing, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria., Anaedu OP; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Ikpeze OZ; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Okpala BC; 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., Emeka EA; Department of Family Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Awka, Nigeria., Nzeukwu CS; Department of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria., Aniedu IC; Department of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria., Chukwuka EC; Department of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Awka, Nigeria., Onwuegbuna AA; Department of Ophthalmology, Nnamdi Azikiwe University, Awka, Nigeria., Ikwuka DC; Department of Human Physiology, Nnamdi Azikiwe University, Nnewi, Anambra State, Nigeria., Chigbo CG; Department of Executive MPH, School of Public Health, University of Port-Harcourt, Port-Harcourt, Rivers State, Nigeria., Agbanu CM; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Onwuka CI; Department of Obstetrics and Gynaecology, College of Medicine, University of Nigeria Ituku-Ozalla, Enugu, Nigeria., Nwankwo ME; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Nneji HC; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Onyeukwu KA; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Odugu BU; Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria., Nweze SO; Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria., Onyekpa IJ; Department of Obstetrics and Gynecology, ESUT Teaching Hospital, Parklane, Enugu, Nigeria., Eze KC; Department of Radiology, Faculty of Medicine, College of Health Sciences, Nnamdi Azikiwe University, Awka, Nigeria., Chukwurah SN; Department of Internal Medicine, Faculty of Medicine, Nnamdi Azikiwe University, Nnewi, Nigeria., Ugboaja JO; Department of Obstetrics and Gynaecology, Nnamdi Azikiwe University Teaching Hospital Nnewi, Nnewi, Anambra State, Nigeria., Ikechebelu JI; 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.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 May 08; Vol. 18 (5), pp. e0285474. Date of Electronic Publication: 2023 May 08 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0285474
Abstrakt: 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.)
Databáze: MEDLINE
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