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Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia

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ClinicalTrials.gov Identifier: NCT02772016
Recruitment Status : Unknown
Verified April 2016 by Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
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:
Seventy-two pregnant patients diagnosed of minor or intermediate beta thalassemia with mild anemia were randomly assigned to treatment group and control group. Patients in the treatment group were given 15 g of Colla corii asini in powder form daily for 4 weeks while the control group were observed and followed up in the same period without any treatments. Levels of hemoglobin(Hb), serum iron (SI), serum ferritin (SF) and three types of hemoglobin components [adult hemoglobin (HbA), fetal hemoglobin (HbF), minor adult hemoglobin (HbA2)] were measured before and after treatments.

Condition or disease Intervention/treatment Phase
Thalassemia Drug: Colla corii asini Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2015
Estimated Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
Patients in the treatment group received daily 15 g oral Colla corii asini(Shandong Dong-E E-Jiao Co., Ltd) in powder form for 4 consecutive weeks. The dosage was adjusted to 10 g per day for 6 consecutive weeks if patients encounter any of the following side effects: swollen gums, dry or sore throat, ulcers in oral cavity.
 Drug: Colla corii asini
15 g of Colla corii asini in powder form daily for 4 weeks
No Intervention: Control group
Patients in control groups do not receive any intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin(Hb) [ Time Frame: Four weeks ]
    the change of hemoglobin(g/L)

  2. Adult hemoglobin(HbA) [ Time Frame: Four weeks ]
    the change of adult hemoglobin(%)

  3. Fetal hemoglobin(HbF) [ Time Frame: Four weeks ]
    the change of fetal hemoglobin(%)

  4. Minor adult hemoglobin(HbA2) [ Time Frame: Four weeks ]
    the change of minor adult hemoglobin(%)


Secondary Outcome Measures :
  1. Serum iron(SI) [ Time Frame: Four weeks ]
    the change of serum iron (umol/L)

  2. Serum ferritin(SF) [ Time Frame: Four weeks ]
    the change of serum ferritin (ng/mL)

  3. Adverse effect [ Time Frame: Four weeks ]
    total white blood count(×109/L)

  4. Adverse effect [ Time Frame: Four weeks ]
    platelet count(×109/L)

  5. Adverse effect [ Time Frame: Four weeks ]
    percentage of neutrophil(%)

  6. Adverse effect [ Time Frame: Four weeks ]
    serum alanine aminotransferase(U/L)

  7. Adverse effect [ Time Frame: Four weeks ]
    serum aspartate aminotransferase(U/L)

  8. Adverse effect [ Time Frame: Four weeks ]
    urea nitrogen (mmol/L)

  9. Adverse effect [ Time Frame: Four weeks ]
    serum creatinine(umol/L)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of minor or intermediate β- thalassemia;
  • patients with mild anemia (80 g/L≤ Hb<110 g/L) prior to study enrollment;
  • singleton pregnancy;
  • patients having not received blood transfusion or any forms of anti-anemia treatment in Western Medicine or Traditional Chinese Medicine in the last 12 weeks;
  • informed consent obtained.

Exclusion Criteria:

  • patients with severe thalassemia;
  • patients with severe anemia (Hb<80 g/L) prior to study enrollment;
  • twin or multiple pregnancies;
  • patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
  • allergic to two or more drugs;
  • patients with mental illness or poor compliance to medical treatment;
  • patients having received blood transfusion or any forms of anti-anemia treatment in Western medicine or Traditional Chinese Medicine in the last 12 weeks;
  • no informed consent obtained.
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): NCT02772016


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   
Sponsors and Collaborators
Yanfang Li
More Information
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Publications:

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Responsible Party: Yanfang Li, Dr., The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02772016    
Other Study ID Numbers: TH-1
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn