- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03392298
Study on the Mechanism of Colla Corri Asini in the Treatment of Thalassemia Patients With Pregnancy Anemia
Investigation of Signal Pathway Induced by Colla Corri Asini Regulating Globin Level in Beta Thalassemia Patients With Pregnancy Anemia
Study Overview
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Yanfang Li, PhD
- Phone Number: +86-20-36598857
- Email: gzyanfangli@hotmail.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510405
- Recruiting
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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Contact:
- Yanfang Li, PhD
- Phone Number: +86-20-36598857
- Email: gzyanfangli@hotmail.com
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Contact:
- Song-ping Luo, professor
- Phone Number: 13005156625
- Email: songpingluo@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant women diagnosed as minor or intermediate β-thalassemia by genetic tests;
- 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;
- Patients having received hemopoietic factors 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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15g Colla corii asini granule, once daily for 4 weeks
Other Names:
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No Intervention: Control group
Participants in Control group will be treated with nothing, but followed up for 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin(Hb)
Time Frame: baseline and week 4
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the change of hemoglobin(g/L)
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baseline and week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the level of α-、β-、γ- and δ-globin mRNA
Time Frame: baseline and week 4
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the change of α-、β-、γ- and δ-globin mRNA(cycle threshold value)
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baseline and week 4
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target gene signaling pathway molecules
Time Frame: baseline and week 4
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the change of gene expression level(fold change)
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baseline and week 4
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yanfang Li, PhD, the first affiliated hospital of Guangzhou University of Chinese Medicine, Guangzhou
Publications and helpful links
General Publications
- 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.
- Cheng 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TH-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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