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

Yanfang Li

Status and phase: Unknown; Early Phase 1

Conditions: Thalassemia

Treatments: Drug: Colla corii asini

Study type: Interventional

Funder types: Other

Identifiers

NCT02772016

TH-1

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Drug: Colla corii asini

Control group

No Intervention group

Description:

Patients in control groups do not receive any intervention.