Objective  To examine improvement effect of a compound soft capsule (mainly composed of Colla corii asini, ferrous lactate and Zaocys dhumnades) on iron deficiency anemia (IDA) in community patients and to provide references for the clinical application of the compound soft capsule.

  Methods  From September to October 2017, we recruited a group of 18 to 65 years old people with self-reported anemia in a region of Hunan province; then 350 people in the group were randomly selected for laboratory tests of IDA diagnosis; finally based on personal hemoglobin (Hb) content, 102 people confirmed with IDA were randomly assigned into two groups (51 in each group) : an experiment group with oral medication of the compound soft capsules (3 capsules once, 3 times per day continuously for 30 days) and a control group with the placebo capsules. Contents of Hb, free portoporphyrin in erythrocytes and serum ferritin of all the participants were detected and compared between the two groups before and after the medication of compound soft capsule and placebo.

  Results  There were no statistically significant differences in body weight, blood pressure, heart rate and biochemical indexes between the two groups before and after the trial (P > 0.05 for all) and all the indicators were within the normal range. No adverse effect of the compound soft capsules on health was observed among all the participants and there were no significant differences in dietary energy, protein and iron intake between the two groups before and after the trail (all P > 0.05). Compared to those of before the administration of the compound soft capsule, the participants of experiment group had significantly higher Hb (121.96 ± 10.60 g/L vs. 104.40 ± 10.25 g/L) and serum ferritin (25.06 ± 7.71 ng/mL vs. 21.72 ± 4.03 ng/mL) after the treatment (both P < 0.05) and the Hb and serum ferritin of the participants of experiment group were also significantly higher than those of the control participants (104.96 ± 12.01 g/L and 21.73 ± 8.24 ng/mL) at the end of the trail (both P < 0.05). There was no significant difference in erythrocyte free portoporphyrin concentration between the two groups before and after the trial (P > 0.05).

  Conclusion  The compound soft capsule has an obvious improvement effect on IDA but no adverse health impact in the trial among community IDA patients.