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Treatment of severe immune thrombocytopenia with hormone resistance by combination of traditional Chinese and Western Medicine

Phase 1
Recruiting
Conditions
Immune thrombocytopenia
Registration Number
ITMCTR2000003847
Lead Sponsor
Shanghai Hospital of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

(1) Aged 18-80 years old male and female;
(2) Patients with ITP who were treated with glucocorticoid for more than 4 weeks met the diagnostic standard of Chinese expert consensus on diagnosis and treatment of adult primary immune thrombocytopenia (Revised Edition) (2018), and TCM syndrome differentiation belongs to Qi and yin deficiency type;
(3) Two consecutive platelet tests (not detected in the same day) <= 20 x 10^9/L;
(4) Those who voluntarily sign informed consent.

Exclusion Criteria

(1) Although it meets the diagnostic criteria of Western medicine, TCM syndrome is not Yin deficiency type;
(2) Patients with history of thrombosis;
(3) HBV, HCV, HIV carriers or patients;
(4) Allergic constitution or allergic to a variety of drugs;
(5) Pregnant or lactating women;
(6) Patients with a history of mental illness;
(7) Suspected or confirmed history of alcohol and drug abuse;
(8) Severe abnormal function of heart, lung, liver and kidney;
(9) Severe or uncontrollable infection;
(10) Those who took other traditional Chinese medicine or participated in other clinical trials in recent 4 weeks;
(11) Any other circumstances in which the investigator believes that the patient should not participate in this study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Bone marrow examination;routine blood test;
Secondary Outcome Measures
NameTimeMethod
Expression of P-gp in CD19+, CD4+;
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