drugset / Trial / NCT03374111

Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)

NCT03374111 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

480 pregnant patients diagnosed of silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia with mild anemia will be randomly assigned to treatment group and control group. Patients in the treatment group will be given 15 g of Colla corii asini powder form daily for 8 weeks and followed up to 42 days postpartum while the control group will be observed and followed up in the same period treated with placebo. Levels of hemoglobin(Hb), reticulocyte (RET), immaturity reticulocyte (IRF), indirect bilirubin(IBIL), total bilirubin(TBIL), lactic dehydrogenase(LDH) will be measured on three visits(baseline, week 4 and week 8). The curative effect of TCM Syndrome( week 8) and undesirable pregnancy outcomes(42 days after giving birth) will be observed.

Timeline

Start
2018-03-01
Primary completion
2019-10-01
Completion
2019-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Colla corii asini Traditional medicine (herbal / TCM) 15 g —

Indications