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)

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)

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ITMCTR

Registry ID

ITMCTR2100005129

Enrollment

Unknown

Registered

2021-07-21

Start date

2018-03-30

Completion date

Unknown

Last updated

2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary immune thrombocytopenia in children

Interventions

case series:Nil

Eligibility

Sex/Gender

All

Age

No minimum to 14 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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;	—

Countries

China

Contacts

Public ContactJin Runming

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

jinrunm@qq.com+86 27 85726762

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026