Thalassemia
Conditions
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.
Interventions
15 g of Colla corii asini in powder form daily for 4 weeks
Sponsors
Yanfang Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin(Hb) | Four weeks | the change of hemoglobin(g/L) |
| Adult hemoglobin(HbA) | Four weeks | the change of adult hemoglobin(%) |
| Fetal hemoglobin(HbF) | Four weeks | the change of fetal hemoglobin(%) |
| Minor adult hemoglobin(HbA2) | Four weeks | the change of minor adult hemoglobin(%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum ferritin(SF) | Four weeks | the change of serum ferritin (ng/mL) |
| Adverse effect | Four weeks | total white blood count(×109/L) |
| Serum iron(SI) | Four weeks | the change of serum iron (umol/L) |
Countries
China
Contacts
Primary ContactYanfang Li, PhD
Outcome results
None listed