Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)
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ClinicalTrials.gov Identifier: NCT03374111 |
Recruitment Status : Unknown
Verified December 2018 by Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was: Recruiting
First Posted : December 15, 2017
Last Update Posted : December 27, 2018
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Condition or disease | Intervention/treatment | Phase |
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Thalassemia | Drug: Colla corii asini Drug: a Simulate Agent of Colla corii asini granule | Phase 4 |
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 in the world and causes heavy burdens on public health system. In China, the southern provinces suffer from high incidence of thalassemia, which is particularly common in the population of Guangdong, Guangxi and Yunnan provinces. Epidemiological studies showed that in Guangdong alone about 17.83 % of the 14,332 pregnant women across 21 regions examined were diagnosed as carriers of thalassemia .
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 480 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | double blind |
Primary Purpose: | Treatment |
Official Title: | A Multi-center Randomized, Double-blind, Placebo-controlled Study of Colla Corii Asini for the Treatment of Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency) |
Actual Study Start Date : | March 1, 2018 |
Estimated Primary Completion Date : | October 1, 2019 |
Estimated Study Completion Date : | December 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental group
15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd) , taken once daily for 8 weeks
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Drug: Colla corii asini
15 g Colla corii asini granule daily for 8 weeks
Other Name: donkey-hide gelatin |
Placebo Comparator: 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
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Drug: a Simulate Agent of Colla corii asini granule
15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks
Other Name: Placebo of Colla corii asini granule |
- Hemoglobin(Hb) [ Time Frame: baseline, week 4 and week 8 ]the change of hemoglobin(g/L)
- reticulocyte (RET) [ Time Frame: baseline, week 4 and week 8 ]the change of reticulocyte (RET)count(×10^9/L)
- immature reticulocyte fraction(IRF) [ Time Frame: baseline, week 4 and week 8 ]the change of immature reticulocyte fraction(%)
- adverse event [ Time Frame: tracked for 42 days after giving birth ]undesirable pregnancy outcomes
- indirect bilirubin(IBIL) [ Time Frame: baseline, week 4 and week 8 ]the change of indirect bilirubin(IBIL)(μmol/L)
- total bilirubin(TBIL) [ Time Frame: baseline, week 4 and week 8 ]the change of total bilirubin(TBIL) (μmol/L)
- lactic dehydrogenase(LDH) [ Time Frame: baseline, week 4 and week 8 ]the change of lactic dehydrogenase(LDH)(U/L)
- anaemia cure rates [ Time Frame: week 8 ]anaemia cure rates(%):The concentration of hemoglobin was higher than baseline > 5g/L;The improvement rate = improved cases/the total number of cases * 100%
- The curative effect of TCM Syndrome [ Time Frame: week 8 ]the change of the TCM syndrome scores of two groups before and after treatment(%)

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Ages Eligible for Study: | 20 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374111
Contact: Song-ping Luo, PhD | 13005156625 | songpingluo@hotmail.com | |
Contact: Zhongqi Yang, PhD | +86-20-36598909 | Yang_zhongqi@163.com |
China, Guangdong | |
The third people's Hospital of Dongguan | Not yet recruiting |
Dongguan, Guangdong, China, 523326 | |
Contact: Lifang Mo 13669853882 478974155@qq.com | |
Intranet of Guangzhou Women and Children's Medical Center | Recruiting |
Guangzhou, Guangdong, China, 510405 | |
Contact: shaoying Wu, PhD 18902268157 wushaoying@163.com | |
the first affiliated hospital of Guangzhou University of Chinese Medicine | Recruiting |
Guangzhou, Guangdong, China, 510405 | |
Contact: Yanfang Li, PhD +86-20-36598857 gzyanfangli@hotmail.com | |
Contact: Song-ping Luo, professor 13005156625 songpingluo@hotmail.com | |
Department of Gynaecology and Obstetrics,Nanfang Hospital, Southern Medical University | Recruiting |
Guangzhou, Guangdong, China, 510515 | |
Contact: Zhijian WANG | |
The First Affiliated Hospital of Jinan University | Recruiting |
Guangzhou, Guangdong, China, 510630 | |
Contact: Rui-man Li | |
The Fifth Affiliated Hospital of Guangzhou Medical University | Recruiting |
Guangzhou, Guangdong, China, 510700 | |
Contact: Junzhao Qiu | |
Dongguan Guangji Hospital | Not yet recruiting |
Guangzhou, Guangdong, China, 523382 | |
Contact: Caifang Wang 15817696003 | |
Shenzhen maternity and child health care hospital | Not yet recruiting |
Shenzhen, Guangdong, China, 518033 | |
Contact: Yan Ning | |
China, Guangxi | |
Liuzhou Municipal Matemal and Child Health Hospital | Recruiting |
Liuzhou, Guangxi, China, 545001 | |
Contact: Yuanliu Wang | |
The Guangxi Zhuang Autonomous Region National Hospital | Recruiting |
Nanning, Guangxi, China, 530001 | |
Contact: Ruo xue You | |
Ruikang Hospital of Guangxi University of Traditional Chinese Medicine | Recruiting |
Nanning, Guangxi, China, 530011 | |
Contact: Xin QIN | |
The First Affiliated Hospital of Guangxi University of Chinese Medicine | Not yet recruiting |
Nanning, Guangxi, China, 530023 | |
Contact: Yong-qin Zhang |
Principal Investigator: | Yanfang Li, PhD | the first affiliated hospital of Guangzhou University of Chinese Medicine , Guangzhou |
Responsible Party: | Yanfang Li, Director, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine |
ClinicalTrials.gov Identifier: | NCT03374111 |
Other Study ID Numbers: |
TH-2 |
First Posted: | December 15, 2017 Key Record Dates |
Last Update Posted: | December 27, 2018 |
Last Verified: | December 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | all collected IPD, all IPD that underlie results in a publication |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | starting in May 2020 when the study have been completed and publication of a clinical trial report. |
Access Criteria: | the information collected about the study will be used to support other research in the future, and may be shared anonymously with other researchers,data will be freely available to anyone upon request. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thalassemia; the Syndrome of Blood Deficiency Anemia Colla Corii Asini |
Anemia Thalassemia Hematologic Diseases Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |