Effect of Ejiao Compound in the Treatment of Postpartum Anemia of Qi-blood Deficiency Syndrome

• Status: Unknown status
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The prevalence of postpartum anemia is a great threat for maternal and infant health without timely and effective treatment. Oral iron therapy has been used for centuries as a treatment of anemia, however, it is noteworthy that treatment with oral iron might have a limited, and even a harmful role in some clinical scenarios. Ejiao compound is composed with donkey-hide glue, Ginseng, Codonopsis pilosula, prepared rhizome of rehmannia, and crab apple, which has been widely used in the treatment of various types of anemia in China for decades and might be a potentially effective therapy for postpartum anemia. Recently, studies involving animal subjects have helped shed light on its mechanism of action.

In this study, the investigators aimed to conduct a randomized controlled trial to assess the efficacy and safety of Ejiao compound comparing with oral iron in the treatment of mild postpartum anemia with or without iron deficiency.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
• Treatments: Iron

Criteria

Inclusion Criteria:

1. Women aged 18 years to 45 years with mild postpartum anemia (Hb <10 g/dl and ≥7 g/dl at 24-48 hours postpartum);

2. Absence of antepartum anemia, which is defined as Hb≥11.0 g/dL within 48 hours before delivery;

3. Singleton pregnancy;

4. Type of syndrome in Traditional Chinese Medicine is "Qi-blood deficiency".

5. Patients having not received blood transfusion or any forms of anti-anemia treatment in Western medicine or TCM in the last 12 weeks;

6. Informed consent obtained.

Exclusion Criteria:

1. Type of syndrome in TCM is NOT "Qi-blood deficiency";

2. Antepartum anemia;

3. Twin or multiple pregnancies;

4. A history of haematological disease (e.g. sickle cell anemia or thalassemias);

5. A history of undigestive disease (e.g. gastric ulcer, gastritis) or inflammatory bowel disease;

6. A history of cardiovascular diseases, renal or liver disease, asthma, thromboembolism, HIV infection, tuberculosis, cancer and seizures;

7. Patients having received blood transfusion or any forms of anti-anemia treatment in Western medicine or TCM in the last 12 weeks;

8. Alcohol or drug abuse;

9. Patients with mental illness or poor compliance to medical treatment;

10. Participation in another clinical trial within the previous three months;

11. No informed consent obtained.