Status:
UNKNOWN
Study on the Mechanism of Colla Corri Asini in the Treatment of Thalassemia Patients With Pregnancy Anemia
Lead Sponsor:
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Thalassemia
Pregnancy
Eligibility:
FEMALE
20-50 years
Phase:
PHASE4
Brief 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. Fir...
Detailed Description
Thalassemia is a type of hemolytic anemia disease caused by genetic defect of synthesis in one or more globin chains. Among all the single genetic disorders, thalassemia has the highest incidence rate...
Eligibility Criteria
Inclusion
- Pregnant women diagnosed as minor or intermediate β-thalassemia by genetic tests;
- 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
- 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;
- Patients having received hemopoietic factors 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;
- 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.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03392298
Start Date
December 1 2017
End Date
February 28 2019
Last Update
January 16 2018
Active Locations (1)
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1
the first affiliated hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405