Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 15, 2016
First Posted Date  ICMJE May 13, 2016
Last Update Posted Date May 13, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Hemoglobin(Hb) [ Time Frame: Four weeks ]
    the change of hemoglobin(g/L)
  • Adult hemoglobin(HbA) [ Time Frame: Four weeks ]
    the change of adult hemoglobin(%)
  • Fetal hemoglobin(HbF) [ Time Frame: Four weeks ]
    the change of fetal hemoglobin(%)
  • Minor adult hemoglobin(HbA2) [ Time Frame: Four weeks ]
    the change of minor adult hemoglobin(%)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • Serum iron(SI) [ Time Frame: Four weeks ]
    the change of serum iron (umol/L)
  • Serum ferritin(SF) [ Time Frame: Four weeks ]
    the change of serum ferritin (ng/mL)
  • Adverse effect [ Time Frame: Four weeks ]
    total white blood count(×109/L)
  • Adverse effect [ Time Frame: Four weeks ]
    platelet count(×109/L)
  • Adverse effect [ Time Frame: Four weeks ]
    percentage of neutrophil(%)
  • Adverse effect [ Time Frame: Four weeks ]
    serum alanine aminotransferase(U/L)
  • Adverse effect [ Time Frame: Four weeks ]
    serum aspartate aminotransferase(U/L)
  • Adverse effect [ Time Frame: Four weeks ]
    urea nitrogen (mmol/L)
  • Adverse effect [ Time Frame: Four weeks ]
    serum creatinine(umol/L)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia
Official Title  ICMJE Not Provided
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thalassemia
Intervention  ICMJE Drug: Colla corii asini
15 g of Colla corii asini in powder form daily for 4 weeks
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Colla corii asini
  • No Intervention: Control group
    Patients in control groups do not receive any intervention.
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: May 11, 2016)
90
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT02772016
Other Study ID Numbers  ICMJE TH-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yanfang Li, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Study Sponsor  ICMJE Yanfang Li
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Verification Date April 2016

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