A registration study on the efficacy and safety of Huaiqihuang granules in the treatment of children with primary immune thrombocytopenia (deficiency of Qi and Yin)

Phase 4

Recruiting

• Conditions: primary immune thrombocytopenia in children; ICD-10: D69.402

• Registration Number: ITMCTR2100005129
• Lead Sponsor: nion Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events;Percentage of abnormal renal function;Recovery rate of immune function or thyroid function indicators;Improvement rate of bleeding degree (clinical effective rate);Incidence of adverse reactions;Abnormal proportion of myocardial enzymes;Proportion of abnormal liver function;