S1 Data -

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).

背景
据我们所知，目前尚无针对Mojeaga制剂（由山柑算盘子Alchornea cordifolia、狼尾草Pennisetum glaucum与双色高粱Sorghum bicolor提取物复配而成的特殊配方）联合产科贫血矫正标准治疗方案时的疗效的随机对照试验。本研究旨在评估Mojeaga作为常规口服铁剂辅助疗法，用于产科人群贫血矫正的疗效、安全性与耐受性。

方法
本研究为一项开放标签的先导性随机对照临床试验。研究纳入尼日利亚三家三级医院中经确诊的贫血患者作为研究对象。符合入组标准的受试者按1:1比例随机分为两组：Mojeaga组接受50mL Mojeaga糖浆（200mg/50mL）联合常规铁剂治疗，每日3次，疗程2周；标准治疗组仅接受常规铁剂治疗，疗程同样为2周。初始治疗2周后复查红细胞比容（hematocrit）水平。主要结局指标为治疗2周后的红细胞比容变化值与中位红细胞比容水平。安全性结局指标包括母体不良事件以及新生儿结局（出生缺陷、低出生体重、胎膜早破与早产）。统计分析采用意向性治疗（intention-to-treat）原则。

结果
共计纳入95名受试者，随机分配至Mojeaga组（n=48）与标准治疗组（n=47）。两组受试者的基线社会人口学特征与临床特征均具有可比性。随访2周后，Mojeaga组的红细胞比容较基线的中位升高值（10.00±7.00% vs 6.00±4.00%；p<0.001）与中位红细胞比容水平（31.00±2.00% vs 27.00±3.00%；p<0.001）均显著高于标准治疗组。Mojeaga组未出现与治疗相关的严重不良事件、先天性畸形或死亡病例，其余新生儿结局的发生率两组间无显著差异（p>0.05）。

结论
Mojeaga可为贫血患者的标准治疗方案提供新的辅助治疗选择。Mojeaga制剂用于妊娠期与产褥期贫血的治疗安全可靠，不会增加先天性畸形或不良新生儿结局的发生风险。

临床试验注册
www.pactr.samrc.ac.za：PACTR201901852059636（https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5822）