Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)
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)
1 other identifier
interventional
480
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2018
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2017
CompletedFirst Posted
Study publicly available on registry
December 15, 2017
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedDecember 27, 2018
December 1, 2018
1.6 years
December 4, 2017
December 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin(Hb)
the change of hemoglobin(g/L)
baseline, week 4 and week 8
Secondary Outcomes (8)
reticulocyte (RET)
baseline, week 4 and week 8
immature reticulocyte fraction（IRF）
baseline, week 4 and week 8
adverse event
tracked for 42 days after giving birth
indirect bilirubin(IBIL)
baseline, week 4 and week 8
total bilirubin(TBIL)
baseline, week 4 and week 8
- +3 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTAL15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd) ， taken once daily for 8 weeks
Control group
PLACEBO COMPARATORa 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
Interventions
15 g Colla corii asini granule daily for 8 weeks
15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- times or more higher plasma creatinine level than high limit of normal state;
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The third people's Hospital of Dongguan
Dongguan, Guangdong, 523326, China
Intranet of Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510405, China
the first affiliated hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405, China
Department of Gynaecology and Obstetrics,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510700, China
Dongguan Guangji Hospital
Guangzhou, Guangdong, 523382, China
Shenzhen maternity and child health care hospital
Shenzhen, Guangdong, 518033, China
Liuzhou Municipal Matemal and Child Health Hospital
Liuchow, Guangxi, 545001, China
The Guangxi Zhuang Autonomous Region National Hospital
Nanning, Guangxi, 530001, China
Ruikang Hospital of Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi, 530011, China
The First Affiliated Hospital of Guangxi University of Chinese Medicine
Nanning, Guangxi, 530023, China
Related Publications (2)
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.
PMID: 27456464BACKGROUNDCheng 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.
PMID: 26949404BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanfang Li, PhD
the first affiliated hospital of Guangzhou University of Chinese Medicine ， Guangzhou
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 4, 2017
First Posted
December 15, 2017
Study Start
March 1, 2018
Primary Completion
October 1, 2019
Study Completion
December 30, 2019
Last Updated
December 27, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, 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.
all collected IPD, all IPD that underlie results in a publication