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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

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.

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Detailed Description

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Conditions

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Thalassemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Colla corii asini

Intervention Type DRUG

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

Control group

Patients in control groups do not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Colla corii asini

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

Intervention Type DRUG

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes