Clinical Evaluation of an Ayurvedic Preparation “Sangfer” for the Treatment of Anemia in Pregnant Women: An Open-labeled Clinical Study

Abstract

Background: Iron deficiency during pregnancy is one of the primary causes of anemia in infants and young children. Ithas a negative impact on maternal and fetal health throughout pregnancy with higher likelihood of adverse maternal andfetal outcomes. Maternal iron supplementation is a critical tool to address the global problem of iron deficiency and preventits negative consequences. Method: An open-label non-comparative prospective clinical trial was carried out to evaluatethe effectiveness of “Sangfer” liquid in 16 pregnant women with anemia. “Sangfer” is a polyherbal Ayurvedic proprietarymedication containing elemental iron and zinc and four medicinal herbs viz. Withania somnifera, Emblica officinalis, Asparagusracemosus and Pueraria tuberosa. The aim of the study was to examine its efficacy and safety in treating anemia in pregnantwomen. The dose administered was 10 mL twice daily after food for 12 weeks (84 days). Patients were evaluated at screening(Visit 1 at Day 0), baseline (Visit 2 at Day 1) and during follow-ups (Visit 3 at Day 28, Visit 4 at Day 56 and Visit 5 atDay 84). Results: There was a significant increase in mean hemoglobin levels from 8.08% at Day 1 to 11.19% at the finalvisit at Day 84. The anemia sign and symptom scores also significantly reduced from Day 1 to different follow-up visits.The mean Physician Global Assessment (PGA) score was found to reduce from 1.0 at Day 1 to 0.0 at the final follow-upvisit. Conclusion: “Sangfer” is highly effective for the treatment of anemia during pregnancy. No adverse effects includingserious adverse effects were observed during the study period.