Clinical trial NCT02772016: Therapeutic Effect of Colla Corii Asini on Improving Anemia and Hemoglobin Composition in Pregnant Women With Thalassemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Thalassemia
Lead sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin(Hb)
timeFrame: Four weeks
measure: Adult hemoglobin(HbA)
timeFrame: Four weeks
measure: Fetal hemoglobin(HbF)
timeFrame: Four weeks
measure: Minor adult hemoglobin(HbA2)
timeFrame: Four weeks
Secondary outcomes:
measure: Serum iron(SI)
timeFrame: Four weeks
measure: Serum ferritin(SF)
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
measure: Adverse effect
timeFrame: Four weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the first affiliated hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
References:
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.
citation: 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.
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. doi: 10.1111/j.1365-2141.2011.09012.x.