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.
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George Uchenna Eleje, Ifeanyichukwu Uzoma Ezebialu, Joseph Tochukwu Enebe, Nnanyelugo Chima Ezeora, Emmanuel Onyebuchi Ugwu, Iffiyeosuo Dennis Ake, Ekeuda Uchenna Nwankwo, Perpetua Kelechi Enyinna, Chukwuemeka Chukwubuikem Okoro, Chika Prince Asuoha, Charlotte Blanche Oguejiofor, Ejeatuluchukwu Obi, Chigozie Geoffrey Okafor, Angela Ogechukwu Ugwu, Lydia Ijeoma Eleje, Divinefavour Echezona Malachy, Chukwunonso Emmanuel Ubammadu, Emeka Philip Igbodike, Chidebe Christian Anikwe, Ifeoma Clara Ajuba, Chinyelu Uchenna Ufoaroh, Richard Obinwanne Egeonu, Lazarus Ugochukwu Okafor, Chukwunonso Isaiah Enechukwu, Sussan Ifeyinwa Nweje, Onyedika Promise Anaedu, Odigonma Zinobia Ikpeze, Boniface Chukwuneme Okpala, Ekene Agatha Emeka, Chijioke Stanley Nzeukwu, Ifeanyi Chibueze Aniedu, Emmanuel Chidi Chukwuka, Arinze Anthony Onwuegbuna, David Chibuike Ikwuka, Chisom God'swill Chigbo, Chiemezie Mac-Kingsley Agbanu, Chidinma Ifechi Onwuka, Malarchy Ekwunife Nwankwo, Henry Chinedu Nneji, Kosisochukwu Amarachukwu Onyeukwu, Boniface Uwaezuoke Odugu, Sylvester Onuegbunam Nweze, Ifeanyi Johnson Onyekpa, Kenneth Chukwudi Eze, Shirley Nneka Chukwurah, Joseph Odirichukwu Ugboaja, and Joseph Ifeanyichukwu Ikechebelu
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Medicine ,Science - Abstract
BackgroundTo 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.MethodsA 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.ResultsNinety 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%;p0.05).ConclusionMojeaga 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 registrationwww.pactr.samrc.ac.za: PACTR201901852059636 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822).
- Published
- 2023
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