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

May 11, 2016 updated by: Yanfang Li
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510405
        • Recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 31 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin(Hb)
Time Frame: Four weeks
the change of hemoglobin(g/L)
Four weeks
Adult hemoglobin(HbA)
Time Frame: Four weeks
the change of adult hemoglobin(%)
Four weeks
Fetal hemoglobin(HbF)
Time Frame: Four weeks
the change of fetal hemoglobin(%)
Four weeks
Minor adult hemoglobin(HbA2)
Time Frame: Four weeks
the change of minor adult hemoglobin(%)
Four weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanfang Li

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

April 15, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-1

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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