ITMCTR2100005129
Recruiting
Phase 4
An open, multicenter, registration study on the efficacy and safety of Huaiqihuang granules in the treatment of children with primary immune thrombocytopenia (deficiency of Qi and Yin)
nion Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology0 sitesTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- primary immune thrombocytopenia in children
- Sponsor
- nion Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) 1 month \<\= age \<\= 14 years old, gender is not limited.
- •(2\) Conformed to the diagnostic criteria of immune thrombocytopenia (ICD\-10 standard) : at least two blood routine tests showed platelets less than 100×109/L and no abnormal blood cell morphology; Skin bleeding spots, petechiae and/or mucosa, visceral bleeding and other clinical manifestations; No splenomegaly in general; Other secondary thrombocytopenia, such as hypoproliferative leukemia, aplastic anemia with thrombocytopenia as the primary hematologic abnormality, hereditary thrombocytopenia, secondary to other immune diseases, and infectious and pharmacological factors, should be excluded.
- •(3\) In line with the diagnostic criteria of traditional Chinese medicine; Qi and Yin deficiency.
- •(4\) The time between the first diagnosis of ITP and the enrollment time is at least 1 month.
- •(5\) Subjects and guardians sign the informed consent form voluntarily (under 8 years old, the guardian signs voluntarily).
Exclusion Criteria
- •(1\) Children with congenital thrombocytopenia;
- •(2\) Children with secondary thrombocytopenia;
- •(3\) Children with non\-immune thrombocytopenia;
- •(4\) Children with a history of diabetes;
- •(5\) Conditions deemed by the investigator not suitable for this study (congenital immune deficiency, suffer from serious acute or chronic diseases, patients with severe infectious diseases, long\-term diarrhea feeding difficulties, those who cannot take drugs orally, drug abusers or suffering from medical conditions that may interfere with study compliance);
- •(6\) Subjects have been enrolled in other clinical studies.
Outcomes
Primary Outcomes
Not specified
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