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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 : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Thalassemia Drug: Colla corii asini Drug: a Simulate Agent of Colla corii asini granule Phase 4

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 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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Thalassemia

Arms and Interventions
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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
 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin(Hb) [ Time Frame: baseline, week 4 and week 8 ]
    the change of hemoglobin(g/L)


Secondary Outcome Measures :
  1. reticulocyte (RET) [ Time Frame: baseline, week 4 and week 8 ]
    the change of reticulocyte (RET)count（×10^9/L）

  2. immature reticulocyte fraction（IRF） [ Time Frame: baseline, week 4 and week 8 ]
    the change of immature reticulocyte fraction(%)

  3. adverse event [ Time Frame: tracked for 42 days after giving birth ]
    undesirable pregnancy outcomes

  4. indirect bilirubin(IBIL) [ Time Frame: baseline, week 4 and week 8 ]
    the change of indirect bilirubin(IBIL)(μmol/L)

  5. total bilirubin(TBIL) [ Time Frame: baseline, week 4 and week 8 ]
    the change of total bilirubin(TBIL) (μmol/L)

  6. lactic dehydrogenase(LDH) [ Time Frame: baseline, week 4 and week 8 ]
    the change of lactic dehydrogenase(LDH)(U/L)

  7. 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%

  8. The curative effect of TCM Syndrome [ Time Frame: week 8 ]
    the change of the TCM syndrome scores of two groups before and after treatment（%）


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Song-ping Luo, PhD 13005156625 songpingluo@hotmail.com
Contact: Zhongqi Yang, PhD +86-20-36598909 Yang_zhongqi@163.com

Locations
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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         
Sponsors and Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Yanfang Li, PhD the first affiliated hospital of Guangzhou University of Chinese Medicine ， Guangzhou
More Information
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Publications:

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Responsible Party: Yanfang Li, Director, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03374111     History of Changes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine:
Thalassemia;
the Syndrome of Blood Deficiency
Anemia
Colla Corii Asini
Additional relevant MeSH terms:
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Anemia
Thalassemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn