Clinical observation and mechanism study of Yiqi Tongyang prescription in the treatment of chronic immune thrombocytopenia
- Conditions
- Immune thrombocytopenia
- Registration Number
- ITMCTR2100004470
- Lead Sponsor
- Xiyuan Hospital, Chinese Academy of traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. The patients with definite diagnosis of ITP, whose course of disease is more than 12 months, aged 18-75 years, 80 x 10^9 /L > PLT >10 x 10 ^ 9 / L or bleeding symptoms;
2. Patients with purpura of spleen and kidney yang deficiency syndrome of TCM;
3. Patients with informed consent, voluntary participation and regular medication.
4. Healthy people with informed consent, voluntary participation and age of 18-60.
1. Patients who received high-dose glucocorticoid pulse therapy within 3 months before treatment.
2. The subjects who received other treatments except hormone within 30 days before treatment, or participated in other clinical studies, which may have an impact on the observation indexes of curative effect.
3. Patients with severe immune deficiency or severe gastrointestinal and / or visceral bleeding.
4. Patients with severe heart, liver and kidney dysfunction: serum creatinine is higher than the upper limit of normal value; Alanine aminotransferase, aspartate aminotransferase and bilirubin were 2 times higher than normal; NYHA grade >= grade II; Or mental illness patients.
5. Pregnant, lactating women or subjects with allergic constitution.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Platelet count;Immune related cytokines;T/B lymphocyte subsets;
- Secondary Outcome Measures
Name Time Method