MDS
Conditions
Interventions
experimental group:Basal treatment + Zaizaoshengxue capsule
Control group:basal treatment + Zaofanwan
Sponsors
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patient has to meet both the diagnostic standard of myelodysplastic syndrome and MDS-RA(RA) of FAB clinical type(myeloid progenitor cell<5%, peripheral blood blast cell<1%), received more than 3 months treatment with western medicine with no response(ineffectiveness), meanwhile, meets the following criterias: (1) consistent reduction(=6 months) of single or multiple lines blood cells (red blood cell[Hb<110g/L]); neutrophil (ANC<1.5×10^9/L) thrombocyte (BPC<100×10^9/L); (2) other dieases belong to Hemotopathy or Non- hemotopathy which can cause reduction of blood cells and dyshaematopiesis have to be excluded; (3) find at least 10% abnormal in any single series including bone marrow smear erythrocytic series, neutrophil series and megakaryocytic series; 2. Patient has to meet the Chinese medicine syndrome standard of liver-kidney deficiency or qi-blood asthenia; 3. Aged between 18 to 70 years; 4. participates voluntarily, and the process of signing informed consent form must meet GCP requirements.
Exclusion criteria
Exclusion criteria: 1. Meeting diagnostic criteria for disease but not TCM syndrome standardization; 2. receiving other clinical trails; 3. combined with severe primary cardiovascular disease, pulmonary disease or hepatic-nephrotic disease; 4. suffering mental disorder or combined with depression; 5. Allergic constitution or be allergic to known component of this experimental capsule; 6. Women who is in lactation period, being pregnant or planning to get pregnant(HCG: women of child-bearing age need to take one test before treatment); 7. 1 month before enrolling into group participated in other drug clinical trails.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hb;RBC;PLT;WBC;NEUT;TCM syndrome; | — |
Countries
China
Contacts
Public ContactXinyi Chen
Outcome results
None listed