Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)
NCT ID: NCT03374111
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
480 participants
INTERVENTIONAL
2018-03-01
2019-12-30
Brief Summary
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Detailed Description
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Recent studies showed that compared with healthy controls, women with thalassemia are associated with a wide range of abnormality and adverse pregnancy outcomes including cardiovascular disease, thrombotic disease, spontaneous miscarriage, premature delivery, oligohydramnios, fetal growth restriction and low birth weight. Currently there is no consensus on treating anemia in pregnant thalassemia patients. Due to the absence of an safe and effective therapeutic measures， many thalassemia patients are prone to develop low level of Hb, which can severely impact the fetal growth and maternal health.
In traditional Chinese medicine (TCM), Colla corii asini (CCA, E'jiao) is a gelatin-like traditional Chinese medicine refined from donkey hide and has been widely used in clinical antanemic therapy for more than 2000 years. In the last decade, many studies had addressed the effect of CCA on the anemia using modern pharmacological approaches. The results indicated that CCA contains collagen protein,glycogen and a variety of trace elements, a variety of amino acids, etc. the main components of CCA can promote hematopoiesis by a number of mechanisms which eventually increase the peripheral erythrocyte counts and Hb concentration. Therefore, the investigators proposed that the hematopoietic effects of CCA might also contribute to the treatment of thalassemia with insuffcient or abnormal Hb concentration.
The study aims to evaluate the efficacy and safety of Colla corii asini (CCA ) in improve anemia during pregnancy among silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia. Four hundred and eighty pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group. Patients in the treatment group will be given 15 g of CCA daily for 8 weeks and followed up to 42 days postpartum, while the control group were 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Experimental group
15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd) ， taken once daily for 8 weeks
Colla corii asini
15 g Colla corii asini granule daily for 8 weeks
Control group
a Simulate Agent of Colla corii asini granule， similar in size, shape，color and taste to Colla corii asini granule, taken once daily for 8 weeks
a Simulate Agent of Colla corii asini granule
15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks
Interventions
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Colla corii asini
15 g Colla corii asini granule daily for 8 weeks
a Simulate Agent of Colla corii asini granule
15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
50 Years
FEMALE
No
Sponsors
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The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
OTHER
Responsible Party
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Yanfang Li
Director
Principal Investigators
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Yanfang Li, PhD
Role: PRINCIPAL_INVESTIGATOR
the first affiliated hospital of Guangzhou University of Chinese Medicine ， Guangzhou
Locations
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The third people's Hospital of Dongguan
Dongguan, Guangdong, China
Intranet of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
the first affiliated hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Department of Gynaecology and Obstetrics,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Dongguan Guangji Hospital
Guangzhou, Guangdong, China
Shenzhen maternity and child health care hospital
Shenzhen, Guangdong, China
Liuzhou Municipal Matemal and Child Health Hospital
Liuzhou, Guangxi, China
The Guangxi Zhuang Autonomous Region National Hospital
Nanning, Guangxi, China
Ruikang Hospital of Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Lifang Mo
Role: primary
shaoying Wu, PhD
Role: primary
Yanfang Li, PhD
Role: primary
Song-ping Luo, professor
Role: backup
Zhijian WANG
Role: primary
Rui-man Li
Role: primary
Junzhao Qiu
Role: primary
Caifang Wang
Role: primary
Yan Ning
Role: primary
Yuanliu Wang
Role: primary
Ruo xue You
Role: primary
Xin QIN
Role: primary
Yong-qin Zhang
Role: primary
References
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Li Y, He H, Yang L, Li X, Li D, Luo S. Therapeutic effect of Colla corii asini on improving anemia and hemoglobin compositions in pregnant women with thalassemia. Int J Hematol. 2016 Nov;104(5):559-565. doi: 10.1007/s12185-016-2069-0. Epub 2016 Jul 25.
Cheng YL, Zhang XH, Sun YW, Wang WJ, Fang SP, Wu ZK. Clinical Effect and Mechanism of Yisui Shengxue Granules in Thalassemia Patients with Mild, Moderate, or Severe Anemia. Evid Based Complement Alternat Med. 2016;2016:1713897. doi: 10.1155/2016/1713897. Epub 2016 Feb 2.
Other Identifiers
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TH-2
Identifier Type: -
Identifier Source: org_study_id