An Evaluation of the Efficacy, Safety, and Tolerability of Abhraloha Compared With Oral Ferrous Ascorbate on Iron Deficiency Anemia in Women: A Randomized Controlled, Parallel-Group, Assessor-Blind Clinical Trial

Abstract

Background and objective Iron deficiency anemia (IDA) is a common condition in women for which ferrous ascorbate (FA) is often prescribed, which can lead to multiple side effects. Abhraloha is an Ayurvedic medicine that has been used for decades in India to treat IDA. In this study, we aimed to evaluate the efficacy and safety of Abhraloha with regard to change in hemoglobin (Hb) levels as compared to the standard treatment using FA in participants with IDA. Materials and methods We conducted a single-center, pragmatic, prospective, randomized, active-controlled, two-arm, parallel-group, assessor-blind study to evaluate the efficacy and safety of Abhraloha with regard to change in Hb levels as compared to the standard treatment using FA in participants suffering from IDA. The eligible participants were randomized and were advised to take either Abhraloha (two tablets twice a day) or FA (one tablet twice a day) for eight weeks; they were asked to follow up after 14 days for re-evaluation. On visit 1 and during the study period, the physician assessed the participants on the Pandurog scale and subjective variables. Descriptive statistics were used with unpaired T-test/Mann-Whitney U test for comparison between the groups. The Wilcoxon signed-rank test was used for within-group analysis, and the chi-square test/Fisher's exact test was employed for categorical data. Results Based on our findings, Abhraloha tablets significantly increased all the variables including the Pandurog scale after eight weeks of treatment. Abhraloha reduced total iron-binding capacity (TIBC) and peripheral smear lymphocyte (PSL), which is consistent with an improvement in IDA. There was a statistically significant increase in Hb, red blood cell (RBC) count, packed cell volume (PCV), mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) in the Abhraloha group as compared with the FA group at eight weeks. The Abhraloha group also exhibited a statistically significant improvement in all the subjective variables. Abhraloha was found to be safe and well-tolerated among the participants. Conclusions Abhraloha possesses hematinic activity and it improves all the blood indices. It is associated with significantly fewer adverse effects compared to oral iron therapy, which proves that it can be safely used for the treatment of IDA.

Keywords: iron deficiency anaemia (ida). anaemia of chronic disease(acd); iron profile; iron tablets.

Figure 1. Enrollment flowchart