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

Primary Purpose

Thalassemia

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Colla corii asini
Sponsored by
Yanfang Li
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thalassemia

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • the first affiliated hospital of Guangzhou University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

Patients in control groups do not receive any intervention.

Outcomes

Primary Outcome Measures

Hemoglobin(Hb)
the change of hemoglobin(g/L)
Adult hemoglobin(HbA)
the change of adult hemoglobin(%)
Fetal hemoglobin(HbF)
the change of fetal hemoglobin(%)
Minor adult hemoglobin(HbA2)
the change of minor adult hemoglobin(%)

Secondary Outcome Measures

Serum iron(SI)
the change of serum iron (umol/L)
Serum ferritin(SF)
the change of serum ferritin (ng/mL)
Adverse effect
total white blood count(×109/L)
Adverse effect
platelet count(×109/L)
Adverse effect
percentage of neutrophil(%)
Adverse effect
serum alanine aminotransferase(U/L)
Adverse effect
serum aspartate aminotransferase(U/L)
Adverse effect
urea nitrogen (mmol/L)
Adverse effect
serum creatinine(umol/L)

Full Information

First Posted
April 15, 2016
Last Updated
May 11, 2016
Sponsor
Yanfang Li
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1. Study Identification

Unique Protocol Identification Number
NCT02772016
Brief Title
Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yanfang Li

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in control groups do not receive any intervention.
Intervention Type
Drug
Intervention Name(s)
Colla corii asini
Intervention Description
15 g of Colla corii asini in powder form daily for 4 weeks
Primary Outcome Measure Information:
Title
Hemoglobin(Hb)
Description
the change of hemoglobin(g/L)
Time Frame
Four weeks
Title
Adult hemoglobin(HbA)
Description
the change of adult hemoglobin(%)
Time Frame
Four weeks
Title
Fetal hemoglobin(HbF)
Description
the change of fetal hemoglobin(%)
Time Frame
Four weeks
Title
Minor adult hemoglobin(HbA2)
Description
the change of minor adult hemoglobin(%)
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Serum iron(SI)
Description
the change of serum iron (umol/L)
Time Frame
Four weeks
Title
Serum ferritin(SF)
Description
the change of serum ferritin (ng/mL)
Time Frame
Four weeks
Title
Adverse effect
Description
total white blood count(×109/L)
Time Frame
Four weeks
Title
Adverse effect
Description
platelet count(×109/L)
Time Frame
Four weeks
Title
Adverse effect
Description
percentage of neutrophil(%)
Time Frame
Four weeks
Title
Adverse effect
Description
serum alanine aminotransferase(U/L)
Time Frame
Four weeks
Title
Adverse effect
Description
serum aspartate aminotransferase(U/L)
Time Frame
Four weeks
Title
Adverse effect
Description
urea nitrogen (mmol/L)
Time Frame
Four weeks
Title
Adverse effect
Description
serum creatinine(umol/L)
Time Frame
Four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanfang Li, PhD
Phone
+86-20-36598857
Email
gzyanfangli@hotmail.com
Facility Information:
Facility Name
the first affiliated hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanfang Li, PhD
Phone
+86-20-36598857
Email
gzyanfangli@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24889414
Citation
Voskaridou E, Balassopoulou A, Boutou E, Komninaka V, Christoulas D, Dimopoulou M, Delaki EE, Loukopoulos D, Terpos E. Pregnancy in beta-thalassemia intermedia: 20-year experience of a Greek thalassemia center. Eur J Haematol. 2014 Dec;93(6):492-9. doi: 10.1111/ejh.12387. Epub 2014 Jun 26.
Results Reference
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PubMed Identifier
26142322
Citation
Costa D, Capuano M, Sommese L, Napoli C. Impact of epigenetic mechanisms on therapeutic approaches of hemoglobinopathies. Blood Cells Mol Dis. 2015 Aug;55(2):95-100. doi: 10.1016/j.bcmd.2015.05.004. Epub 2015 May 12.
Results Reference
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PubMed Identifier
22512001
Citation
Pavord S, Myers B, Robinson S, Allard S, Strong J, Oppenheimer C; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012 Mar;156(5):588-600. doi: 10.1111/j.1365-2141.2011.09012.x. Erratum In: Br J Haematol. 2012 Aug;158(4):559.
Results Reference
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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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