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

• Status: Unknown status
• Trial end date: 2019-12-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

• Pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia;

• Patients with mild anemia (70 g/L≤ Hb<100 g/L) prior to study enrollment;

• Singleton pregnancy ;

• Gestational age between 24-32 weeks;

• Patients having not received blood transfusion in the last 12 weeks;

• Written informed consent of the patient.

Exclusion Criteria:

• Known history of allergy or reaction to any component of the investigational product;

• Allergic to two or more drugs;

• Patients with severe thalassemia;

• Anaemia not caused by thalassemia (e.g., iron deficiency, aplastic, megaloblastic or haemolytic anaemia) or bone marrow diseases, leukemia.

• Twin or multiple pregnancies;

• Placental Abnormality (e.g., placenta previa, multilobate placenta, placenta succenturiate, placenta cirumvallate) or polyhydramnios, oligohydramnios, fetal growth restriction, fetal anomaly;

• Patients having received hemopoieticfactors or treated by hematopoietic stem cell transplantation in the last 2 months;

• Hypersplenism or hypertensive disorder in pregnancy;

• Patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;

• 1.5 times or more higher plasma creatinine level than high limit of normal state;

• 1.5 times or more higher AST or ALT than high limit of normal state;

• Patients with mental illness;

• Patients who suffer from drug or alcohol abuse;

• Patients who addicted to smoking and drinking;

• Participation in any clinical investigational drug study within the previous 3 months;

• Patients who are regarded as ineligible for this study by investigator.