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Colla Corii Asini Treating Anemia in Pregnant Women With Thalassemia(Presenting the Syndrome of Blood Deficiency)

NCT03374111 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2018-12-27

No results posted yet for this study

Summary

480 pregnant patients diagnosed of silent or standard α-thalassemia, HbH disease, minor or intermediate β-thalassemia with mild anemia will be randomly assigned to treatment group and control group. Patients in the treatment group will be given 15 g of Colla corii asini powder form daily for 8 weeks and followed up to 42 days postpartum while the control group will be observed and followed up in the same period treated with placebo. Levels of hemoglobin(Hb), reticulocyte (RET), immaturity reticulocyte (IRF), indirect bilirubin(IBIL), total bilirubin(TBIL), lactic dehydrogenase(LDH) will be measured on three visits(baseline, week 4 and week 8). The curative effect of TCM Syndrome( week 8) and undesirable pregnancy outcomes(42 days after giving birth) will be observed.

Conditions

Interventions

DRUG

Colla corii asini

15 g Colla corii asini granule daily for 8 weeks

DRUG

a Simulate Agent of Colla corii asini granule

15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks

Sponsors & Collaborators

  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Yanfang Li, PhD · the first affiliated hospital of Guangzhou University of Chinese Medicine ， Guangzhou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2019-10-01
Completion
2019-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374111 on ClinicalTrials.gov