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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thalassemia Pregnancy Drug: Colla corii asini 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of Signal Pathway Induced by Colla Corri Asini Regulating Globin Level in Beta Thalassemia Patients With Pregnancy Anemia
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Colla corii asini
15g Colla corii asini granule, once daily for 4 weeks
Other Name: donkey-hide gelatin
No Intervention: Control group
Participants in Control group will be treated with nothing, but followed up for 4 weeks.


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


Secondary Outcome Measures :
  1. 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)

  2. target gene signaling pathway molecules [ Time Frame: baseline and week 4 ]
    the change of gene expression level(fold change)


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  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.
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): NCT03392298


Contacts
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Contact: Yanfang Li, PhD +86-20-36598857 gzyanfangli@hotmail.com

Locations
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China, Guangdong
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   
Sponsors and Collaborators
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
National Natural Science Foundation of China
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, associate chief physician, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03392298    
Other Study ID Numbers: TH-3
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pregnancy
Globin expression
Colla corii asini
Additional relevant MeSH terms:
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Thalassemia
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn