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Study on the Mechanism of Colla Corri Asini in the Treatment of Thalassemia Patients With Pregnancy Anemia

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ClinicalTrials.gov Identifier: NCT03392298
Recruitment Status : Unknown
Verified December 2017 by Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : January 5, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
National Natural Science Foundation of China
Information provided by (Responsible Party):
Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE January 2, 2018
First Posted Date  ICMJE January 5, 2018
Last Update Posted Date January 16, 2018
Actual Study Start Date  ICMJE December 1, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
Hemoglobin(Hb) [ Time Frame: baseline and week 4 ]
the change of hemoglobin(g/L)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • the level of α-、β-、γ- and δ-globin mRNA [ Time Frame: baseline and week 4 ]
    the change of α-、β-、γ- and δ-globin mRNA(cycle threshold value)
  • target gene signaling pathway molecules [ Time Frame: baseline and week 4 ]
    the change of gene expression level(fold change)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2018)
  • the level of α-、β-、γ- and δ-globin [ Time Frame: baseline and week 4 ]
    the change of α-、β-、γ- and δ-globin level
  • target gene signaling pathway molecules [ Time Frame: baseline and week 4 ]
    the change of gene expression level
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Mechanism of Colla Corri Asini in the Treatment of Thalassemia Patients With Pregnancy Anemia
Official Title  ICMJE Investigation of Signal Pathway Induced by Colla Corri Asini Regulating Globin Level in Beta Thalassemia Patients With Pregnancy Anemia
Brief Summary This study aims to explore the pathways and targets of regulating globin expression, which might be related to Colla corii asini (CCA, E'jiao) treating anemia in pregnant women with β-thalassemia. Firstly, ten pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group in a 1: 1 ratio. The patients in the treatment group will be given 15 g of CCA daily for 4 weeks and followed up, while the control group will be treated with nothing and followed up in the same period. The transcriptional test and bioinformatics analysis would be conducted to detect and determine the potential pathways and targets of regulating globin expression before and after the treatment. Secondly, sixty pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group in a 2: 1 ratio. The treatment group and control group respectively received the same treatment and follow-up regimen as the transcriptional study mentioned above. According to the results of the transcriptional study, the target gene signaling pathway molecules, Hb concentration, and the levels of α-、β-、γ- and δ-globin will be detected and compared.
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 after pregnancy, anemia in β-thalassemia patients tends to turn more serious, the risk of adverse pregnancy outcomes accordingly increase. Currently, no consensus has been reached in treating pregnant thalassemia patients due to lack of safe and effective treatment. Regulation of globin gene expression is the key link of β-thalassemia treatment, but the accessible western medicines have many limitations, including bone marrow suppression, carcinogenicity and teratogenicity, and are not suitable for pregnant patients.

In China, 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.

Our previous clinical study showed that CCA can significantly increase the level of hemoglobin and adult hemoglobin (HbA,α2β2) in the pregnant women with β-thalassemia, it was speculated that CCA might induce β globin gene expression, which would be more beneficial to pregnant women than the γ globin gene inducer. But its regulatory pathway is not clear.

This study is designed to explore the pathways and targets of regulating globin expression by using the transcriptomics method, which might be related to CCA treating pregnant anemia in β-thalassemia patients. And then the results of transcriptomics study will be further verified by expanding the clinical samples and implementing cell experiments, aiming to explore the mechanisms of CCA in treating β-thalassemia with pregnant anemia by regulating globin expression.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Thalassemia
  • Pregnancy
Intervention  ICMJE Drug: Colla corii asini
15g Colla corii asini granule, once daily for 4 weeks
Other Name: donkey-hide gelatin
Study Arms  ICMJE
  • Experimental: CCA group
    Participants in CCA group will be treated with 15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd), once daily for 4 weeks.
    Intervention: Drug: Colla corii asini
  • No Intervention: Control group
    Participants in Control group will be treated with nothing, but followed up for 4 weeks.
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2019
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Pregnant women diagnosed as minor or intermediate β-thalassemia by genetic tests;
  2. Patients with mild anemia (70 g/L≤ Hb<100 g/L) prior to study enrollment;
  3. Singleton pregnancy ;
  4. Gestational age between 24-32 weeks;
  5. Patients having not received blood transfusion in the last 12 weeks;
  6. Written informed consent of the patient.

Exclusion Criteria:

  1. Known history of allergy or reaction to any component of the investigational product;
  2. Allergic to two or more drugs;
  3. Patients with severe thalassemia;
  4. Anaemia not caused by thalassemia (e.g., iron deficiency, aplastic, megaloblastic or haemolytic anaemia) or bone marrow diseases, leukemia;
  5. Twin or multiple pregnancies;
  6. Patients having received hemopoietic factors or treated by hematopoietic stem cell transplantation in the last 2 months;
  7. Hypersplenism or hypertensive disorder in pregnancy;
  8. Patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
  9. Patients with mental illness;
  10. Patients who suffer from drug or alcohol abuse;
  11. Patients who addicted to smoking and drinking;
  12. Participation in any clinical investigational drug study within the previous 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03392298
Other Study ID Numbers  ICMJE TH-3
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: No
Current Responsible Party Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Natural Science Foundation of China
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 2017

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