Background To our knowledge, there is no prior randomized trial on the effectiveness of Mojeaga remedy (a special blend of Alchornea, Pennisetum, and Sorghum 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 mean 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 mean rise in hematocrit values from baseline (10.42±4.13% vs 6.36±3.69%;p<0.001) and mean hematocrit values (31.21±2.52% vs 27.7±3.49%;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.

The authors have declared no competing interest.

Clinical Trial Registration: www.pactr.samrc.ac.za: PACTR201901852059636.

This study was (partially) funded by the Mojeaga International Ventures Ltd, Nigeria. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol was approved by the Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria ethics committee and other collaborating hospitals, with the approval numbers: NAUTH/CS/66/VOL.12/014/2019/008, ESUTHP/C-MAC/RA/034/103, and COOUTH/CMAC/ETH.C/VOL.1/0056.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

All relevant data are within the manuscript and its Supporting Information files.