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

Thalassemia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02772016
• Other study ID #: TH-1
• Status: Recruiting
• Phase: Early Phase 1
• First received: April 15, 2016
• Last updated: May 11, 2016
• Start date: March 2015

Study information

• Verified date: April 2016
• Source: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Contact: Yanfang Li, PhD
• Phone: +86-20-36598857
• Email: gzyanfangli[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• pregnant women diagnosed as thalassemia carriers by genetic test with clinical presentation of minor or intermediate ß- 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.

Related Conditions & MeSH terms

• Thalassemia

Intervention

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

Locations

Country	Name	City	State
China	the first affiliated hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Yanfang Li

Country where clinical trial is conducted

China, 

References & Publications (3)

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. Review. — View 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. Erratum in: Br J Haematol. 2012 Aug;158(4):559. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin(Hb)	the change of hemoglobin(g/L)	Four weeks
Primary	Adult hemoglobin(HbA)	the change of adult hemoglobin(%)	Four weeks
Primary	Fetal hemoglobin(HbF)	the change of fetal hemoglobin(%)	Four weeks
Primary	Minor adult hemoglobin(HbA2)	the change of minor adult hemoglobin(%)	Four weeks
Secondary	Serum iron(SI)	the change of serum iron (umol/L)	Four weeks
Secondary	Serum ferritin(SF)	the change of serum ferritin (ng/mL)	Four weeks
Secondary	Adverse effect	total white blood count(×109/L)	Four weeks
Secondary	Adverse effect	platelet count(×109/L)	Four weeks
Secondary	Adverse effect	percentage of neutrophil(%)	Four weeks
Secondary	Adverse effect	serum alanine aminotransferase(U/L)	Four weeks
Secondary	Adverse effect	serum aspartate aminotransferase(U/L)	Four weeks
Secondary	Adverse effect	urea nitrogen (mmol/L)	Four weeks
Secondary	Adverse effect	serum creatinine(umol/L)	Four weeks