Trial | NCT02772016  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    collagen ...

  • Study Participants

    90
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.
Study Started
Mar 31
2015
Primary Completion
May 31
2016
Anticipated
Last Update
May 13
2016
Estimate

Drug Colla corii asini

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

Intervention group Experimental

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.

Control group No Intervention

Patients in control groups do not receive any intervention.

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.
No Results Posted