myelodysplastic syndromes
Conditions
Interventions
control group:Yisui Granules placebo ± supportive therapy: placebo 1 sachet each time 2 times a day orally.
Experimental group:Yisui Granules ± supportive therapy: Yisui Granules 1 sachet each time 2 times a day orally.
Sponsors
Dongzhimen Hospital Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Meeting all 6 criteria below:1) Patients meeting MDS diagnostic criteria AND TCM syndrome diagnostic criteria;2) IPSS score =1;3) Age =18 years;4) ECOG score 0-3;5) Hemoglobin (HGB) <110 g/L and/or neutrophil count (ANC) <1.8×109/L, and/or platelet count (PLT) <100×109/L;6) Voluntarily agree to participate and sign informed consent form.
Exclusion criteria
Exclusion criteria: Meeting any one of the following criteria:1) Secondary or therapy-related MDS;2) del(5q)/5q- and/or one other cytogenetic abnormality (except -7/7q-);3) Ring sideroblasts =5% of nucleated red blood cells, OR =5% with SF3B1 mutation;4) Severe heart/lung/liver/kidney dysfunction or organ damage;5) Uncontrolled clinically significant systemic infection (viral/bacterial/fungal) requiring treatment; OR known HIV, active HBV/HCV infection;6) Other advanced malignancies with life expectancy <24 weeks;7) Previous treatment failure with similar TCM plus high-dose EPO or high-dose EPO alone;8) Allergy to trial drugs/components; 9) Receiving other treatments/clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood routine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Chinese Medicine Score;Hematologic improvement rate;Incidence of grade 2 or higher bleeding events;Quality of Life Score for Cancer Patients (EORTC QLQ-C30);Incidence of infections; | — |
Countries
China
Contacts
Public ContactTian Shaodan
Dongzhimen Hospital Beijing University of Chinese Medicine
Outcome results
None listed