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

Study Overview
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Brief Summary
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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.

Conditions
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Thalassemia

Intervention / Treatment
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* Drug: Colla corii asini


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 15 g of Colla corii asini in powder form daily for 4 weeks<br>|
| No Intervention: Control group<br>Patients in control groups do not receive any intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum iron(SI) | the change of serum iron (umol/L) | Four weeks | 
| Serum ferritin(SF) | the change of serum ferritin (ng/mL) | Four weeks | 
| Adverse effect | total white blood count(×109/L) | Four weeks | 
| Adverse effect | platelet count(×109/L) | Four weeks | 
| Adverse effect | percentage of neutrophil(%) | Four weeks | 
| Adverse effect | serum alanine aminotransferase(U/L) | Four weeks | 
| Adverse effect | serum aspartate aminotransferase(U/L) | Four weeks | 
| Adverse effect | urea nitrogen (mmol/L) | Four weeks | 
| Adverse effect | serum creatinine(umol/L) | Four weeks |