Study on the Mechanism of Colla Corri Asini in the Treatment of Thalassemia Patients With Pregnancy Anemia

• Status: Unknown status
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to explore the pathways and targets of regulating globin expression, which might be related to Colla corii asini (CCA, E'jiao) treating anemia in pregnant women with β-thalassemia. Firstly, ten pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group in a 1: 1 ratio. The patients in the treatment group will be given 15 g of CCA daily for 4 weeks and followed up, while the control group will be treated with nothing and followed up in the same period. The transcriptional test and bioinformatics analysis would be conducted to detect and determine the potential pathways and targets of regulating globin expression before and after the treatment. Secondly, sixty pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group in a 2: 1 ratio. The treatment group and control group respectively received the same treatment and follow-up regimen as the transcriptional study mentioned above. According to the results of the transcriptional study, the target gene signaling pathway molecules, Hb concentration, and the levels of α-、β-、γ- and δ-globin will be detected and compared.

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

Details

• Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Collaborator: National Natural Science Foundation of China

Criteria

Inclusion Criteria:

1. Pregnant women diagnosed as minor or intermediate β-thalassemia by genetic tests;

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

3. Singleton pregnancy ;

4. Gestational age between 24-32 weeks;

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

6. Written informed consent of the patient.

Exclusion Criteria:

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

2. Allergic to two or more drugs;

3. Patients with severe thalassemia;

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

5. Twin or multiple pregnancies;

6. Patients having received hemopoietic factors or treated by hematopoietic stem cell transplantation in the last 2 months;

7. Hypersplenism or hypertensive disorder in pregnancy;

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

9. Patients with mental illness;

10. Patients who suffer from drug or alcohol abuse;

11. Patients who addicted to smoking and drinking;

12. Participation in any clinical investigational drug study within the previous 3 months.