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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

Tracking Information
First Submitted Date  ICMJE December 4, 2017
First Posted Date  ICMJE December 15, 2017
Last Update Posted Date December 27, 2018
Actual Study Start Date  ICMJE March 1, 2018
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
Hemoglobin(Hb) [ Time Frame: baseline, week 4 and week 8 ]
the change of hemoglobin(g/L)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03374111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • 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(%)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Thalassemia
Intervention  ICMJE
  • Drug: Colla corii asini
    15 g Colla corii asini granule daily for 8 weeks
    Other Name: donkey-hide gelatin
  • 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
Study Arms  ICMJE
  • Experimental: Experimental group
    15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd) , taken once daily for 8 weeks
    Intervention: Drug: Colla corii asini
  • 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
    Intervention: Drug: a Simulate Agent of Colla corii asini granule
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date October 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Song-ping Luo, PhD 13005156625 songpingluo@hotmail.com
Contact: Zhongqi Yang, PhD +86-20-36598909 Yang_zhongqi@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374111
Other Study ID Numbers  ICMJE TH-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: all collected IPD, all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study Sponsor  ICMJE The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yanfang Li, PhD the first affiliated hospital of Guangzhou University of Chinese Medicine , Guangzhou
PRS Account The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP