Study on the Mechanism of Colla Corri Asini in the Treatment of Thalassemia Patients With Pregnancy Anemia

NCT03392298 | Unknown Phase 4

• 1 other identifier: TH-3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the pathways and targets of regulating globin expression, which might be related to Colla corii asini (CCA, E'jiao) treating anemia in pregnant women with β-thalassemia. Firstly, ten pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group in a 1: 1 ratio. The patients in the treatment group will be given 15 g of CCA daily for 4 weeks and followed up, while the control group will be treated with nothing and followed up in the same period. The transcriptional test and bioinformatics analysis would be conducted to detect and determine the potential pathways and targets of regulating globin expression before and after the treatment. Secondly, sixty pregnant patients who meet inclusion criteria will be randomly assigned to either the treatment group or control group in a 2: 1 ratio. The treatment group and control group respectively received the same treatment and follow-up regimen as the transcriptional study mentioned above. According to the results of the transcriptional study, the target gene signaling pathway molecules, Hb concentration, and the levels of α-、β-、γ- and δ-globin will be detected and compared.

Conditions

Thalassemia; Pregnancy

Keywords

Thalassemia; Pregnancy; Globin expression; Colla corii asini

Outcome Measures

Primary Outcomes (1)

• Hemoglobin(Hb)

  the change of hemoglobin(g/L)

  baseline and week 4

Secondary Outcomes (2)

• the level of α-、β-、γ- and δ-globin mRNA

  baseline and week 4

• target gene signaling pathway molecules

  baseline and week 4

Study Arms (2)

CCA group

EXPERIMENTAL

Participants in CCA group will be treated with 15g of Colla corii asini granule( produced by Dong-E E-Jiao Co., Ltd)， once daily for 4 weeks.

Drug: Colla corii asini

Control group

NO INTERVENTION

Participants in Control group will be treated with nothing, but followed up for 4 weeks.

Interventions

Colla corii asini DRUG

15g Colla corii asini granule, once daily for 4 weeks

Also known as: donkey-hide gelatin

CCA group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women diagnosed as minor or intermediate β-thalassemia by genetic tests;
• Patients with mild anemia (70 g/L≤ Hb\<100 g/L) prior to study enrollment;
• Singleton pregnancy ;
• Gestational age between 24-32 weeks;
• Patients having not received blood transfusion in the last 12 weeks;
• Written informed consent of the patient.

You may not qualify if:

• Known history of allergy or reaction to any component of the investigational product;
• Allergic to two or more drugs;
• Patients with severe thalassemia;
• Anaemia not caused by thalassemia (e.g., iron deficiency, aplastic, megaloblastic or haemolytic anaemia) or bone marrow diseases, leukemia;
• Twin or multiple pregnancies;
• Patients having received hemopoietic factors or treated by hematopoietic stem cell transplantation in the last 2 months;
• Hypersplenism or hypertensive disorder in pregnancy;
• Patients with any of the following abnormalities: immunodeficiency, primary diseases involving cardiovascular system, liver, kidney, gastrointestinal tract, endocrine system and hematological system;
• Patients with mental illness;
• Patients who suffer from drug or alcohol abuse;
• Patients who addicted to smoking and drinking;
• Participation in any clinical investigational drug study within the previous 3 months.

Sponsors & Collaborators

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

the first affiliated hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

RECRUITING

Related Publications (2)

• Li Y, He H, Yang L, Li X, Li D, Luo S. Therapeutic effect of Colla corii asini on improving anemia and hemoglobin compositions in pregnant women with thalassemia. Int J Hematol. 2016 Nov;104(5):559-565. doi: 10.1007/s12185-016-2069-0. Epub 2016 Jul 25.

  PMID: 27456464 BACKGROUND

• Cheng YL, Zhang XH, Sun YW, Wang WJ, Fang SP, Wu ZK. Clinical Effect and Mechanism of Yisui Shengxue Granules in Thalassemia Patients with Mild, Moderate, or Severe Anemia. Evid Based Complement Alternat Med. 2016;2016:1713897. doi: 10.1155/2016/1713897. Epub 2016 Feb 2.

  PMID: 26949404 BACKGROUND

MeSH Terms

Conditions

Thalassemia

Interventions

colla corii asini

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yanfang Li, PhD

  the first affiliated hospital of Guangzhou University of Chinese Medicine, Guangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanfang Li, PhD

CONTACT

+86-20-36598857; gzyanfangli@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 5, 2018
• Study Start: December 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: January 16, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)