NCT02772016

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
Last Updated

May 13, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

April 15, 2016

Last Update Submit

May 11, 2016

Conditions

Thalassemia

Outcome Measures

Primary Outcomes (4)

  • Hemoglobin(Hb)

    the change of hemoglobin(g/L)

    Four weeks

  • Adult hemoglobin(HbA)

    the change of adult hemoglobin(%)

    Four weeks

  • Fetal hemoglobin(HbF)

    the change of fetal hemoglobin(%)

    Four weeks

  • Minor adult hemoglobin(HbA2)

    the change of minor adult hemoglobin(%)

    Four weeks

Secondary Outcomes (9)

  • Serum iron(SI)

    Four weeks

  • Serum ferritin(SF)

    Four weeks

  • Adverse effect

    Four weeks

  • Adverse effect

    Four weeks

  • Adverse effect

    Four weeks

  • +4 more secondary outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in control groups do not receive any intervention.

Interventions

Colla corii asiniDRUG

15 g of Colla corii asini in powder form daily for 4 weeks

Intervention group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 24889414BACKGROUND

  • 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.

    PMID: 26142322BACKGROUND

  • 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.

    PMID: 22512001BACKGROUND

MeSH Terms

Conditions

Thalassemia

Interventions

colla corii asini

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Yanfang Li, PhD

CONTACT

+86-20-36598857gzyanfangli@hotmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 15, 2016

First Posted

May 13, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-04

Locations

CN(1)