Immune Thrombocytopenia
Conditions
Interventions
Study Group A:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously
Study Group A:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration
Control group B:Traditional Chinese Medicine for control group
Control group B:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration
Study Group C:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously
Study Group C:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L
Control Group D:Traditional Chinese Medicine for control group
Control Group D:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L
Sponsors
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. male or female aged between 18 and 75 years; 2. Yinxu typed Relapsed or refractory ITP patients diagnosed with Chinese Consensus on the Diagnosis and Treatment for Adult Immunothrombocytopenia (2011 Edition) who haven't achieved remission after four or more weeks treatment of glucocorticoids; 3. Platelet count below 30*10^9/L twice in succession (not inspected in the same day); 4. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. ITP patients diagnosed by modern medicine, but not Yinxu type by traditional Chinese medicine; 2. Patients with thrombus history; 3. HCV, HBV, or HIV carriers or patients; 4. Patients allergic to multiple medicine; 5. Pregnant or nursing women; 6. Psychiatric history; 7. History of suspected abuse of alcohol or drugs; 8. Severe heart, lung, liver or kidney dysfunction; 9. Severe or uncontrolled infection; 10. Patients who have taken traditional Chinese medicine during the last four weeks or who have participated in other clinical trials; 11. Other situations not approved by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet count;Bone marrow proliferation;Bone marrow biopsy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum TPO concentration;Serum TPO antibody; | — |
Countries
China
Contacts
Public ContactJunmin Li
Ruijin hospital affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Institute of Hematology
Outcome results
None listed