Iron-Deficiency Anemia
Conditions
Keywords
Iron-Deficiency Anemia, Buxue Yimu Pills, Ferrous Sulfate, clinical observations, adult women, Metabonomics
Brief summary
This study evaluates Buxue Yimu Pills，Ferrous Sulfate and the addition of Buxue Yimu Pills to Ferrous Sulfate in the treatment of Iron-Deficiency Anemia in adults women. One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
Detailed description
Buxue Yimu Pills, Ferrous Sulfate each Improve anemia, but they do so by different machanisms. We generally treat patients with uncomplicated Iron Deficiency Anemia with oral iron due to the ease of administration，and Ferrous Sulfate is one of the most commonly used drugs. Buxue Yimu Pills consists of multiple chinses herbs including Angelica Sinensis，Astragalus，Donkey-Hide Gelatin，Herba Leonuri，Citrus etc., which gains widespread application in the treatment after women's abortion or operations of uterine cavity. Based on the characteristics above, we try to explore its clinical application value in Gynecological Iron-Deficiency Anemia.
Interventions
DRUGBuxue Yimu Pills
Buxue Yimu Pills 12g pill by mouth, twice daily.
DRUGBuxue Yimu Pills &Ferrous Sulfate
Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
DRUGFerrous Sulfate
Ferrous Sulfate 0.3g tablet by mouth, three times daily
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
One third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Buxue Yimu Pills, one third of participanta will receive Ferrous Sulfate，and the another third will receive Buxue Yimu Pills and Ferrous Sulfate in combination.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Subject is a female between the age of 18 and 50. * Subject suffers from mild to moderate anemia with a hemoglobin between 80g/L and 110 g/L. * Subject has definite gynecological etiological factors of iron deficiency * Subject provides written informed consent.
Exclusion criteria
* Subject underwent chronic digestive tract inflammation，uncontrolled digestive or urinary system bleeding. * Subject has other complications in addition to gynecological diseases leading to iron deficiency，such as hemorrhagic diseases of hematologic system，parasitic diseases like ancylostomiasis，chronic intravascular hemolysis，mechanical hemolysis like prosthetic valve，renal dysfunction and hemodialysis. * Subject is pregnant or lactating. * Subject has a severe systemic disease, such as cardiovascular system * Subject has a history of malignancy or radiotherapy. * Subject has undergone any Iron deficiency anemia treatment including Iron supplements or blood transfusion within 1month prior to randomization. * Subject has mental disorder incapable of elementary cooperations. * Subject has participated in other clinical researches of medicine within 1month prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Blood Count | 5 minutes | Anemia Related Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Short Form-36 Health Survey (Sf-36) | 10 minutes | Information about health |
| Hepatic Function | 5 minutes | Safety Monitoring |
| Renal Function | 5 minutes | Safety Monitoring |
| Blood Glucose | 5 minutes | Safety Monitoring |
| Electrolyte Semiconductor Junction | 5 minutes | Safety Monitoring |
| Electrocardiogram(ECG) | 5 minutes | Safety Monitoring |
| Iron Metabolism index | 5 minutes | Anemia Related Assessment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabonomics Measurement | 1hour | Extensive and profound Information |
Countries
China
Contacts
Primary ContactLei L Li, MD
Outcome results
None listed