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

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).