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© 2023 Eleje et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

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).

Details

Title
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
Eleje, George Uchenna  VIAFID ORCID Logo  ; Ezebialu, Ifeanyichukwu Uzoma; Enebe, Joseph Tochukwu; Ezeora, Nnanyelugo Chima; Ugwu, Emmanuel Onyebuchi  VIAFID ORCID Logo  ; Iffiyeosuo, Dennis Ake; Nwankwo, Ekeuda Uchenna; Perpetua Kelechi Enyinna; Okoro, Chukwuemeka Chukwubuikem  VIAFID ORCID Logo  ; Chika Prince Asuoha; Charlotte Blanche Oguejiofor; Obi, Ejeatuluchukwu; Okafor, Chigozie Geoffrey  VIAFID ORCID Logo  ; Angela Ogechukwu Ugwu; Eleje, Lydia Ijeoma; Divinefavour Echezona Malachy Chukwunonso Emmanuel Ubammadu; Igbodike, Emeka Philip; Chidebe, Christian Anikwe; Ajuba, Ifeoma Clara; Ufoaroh, Chinyelu Uchenna; 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  VIAFID ORCID Logo  ; Aniedu, Ifeanyi Chibueze; Chukwuka, Emmanuel Chidi; Arinze, Anthony Onwuegbuna; Ikwuka, David Chibuike  VIAFID ORCID Logo  ; Chiemezie Mac-Kingsley Agbanu Chidinma Ifechi Onwuka; Malarchy Ekwunife Nwankwo Henry Chinedu Nneji; Onyeukwu, Kosisochukwu Amarachukwu  VIAFID ORCID Logo  ; Boniface Uwaezuoke Odugu; Nweze, Sylvester Onuegbunam; Ifeanyi Johnson Onyekpa; Kenneth Chukwudi Eze  VIAFID ORCID Logo 
First page
e0285474
Section
Research Article
Publication year
2023
Publication date
May 2023
Publisher
Public Library of Science
e-ISSN
19326203
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2811188905
Copyright
© 2023 Eleje et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.