The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia

  • STATUS
    Recruiting
  • End date
    Sep 20, 2022
  • participants needed
    216
  • sponsor
    Qidong Gaitianli Medicines Co., Ltd
Updated on 2 August 2021
blood tests
anemia
initial diagnosis
thrombocytopenia
aptt
autoimmune disease
huaiqihuang
autoimmune thrombocytopenia

Summary

This is a multisite, double-blind, randomized, placebo-controlled, and parallel study designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to children with chronic primary immune thrombocytopenia (Qi Yin deficiency).

Description

The randomized clinical trial included subjects (n =216) will be randomly divided into experimental (n = 162) and control groups (n =54) according to a random number table. Patients in the experimental group will receive Huaiqihuang Granule . Patients in the control group will receive placebo a placebo-controlled designed is used for this study. To minimize the risks, treatment stopping rules and subsequent measures are established for subjects whose disease under study become worsening during the study. Subjects receiving placebo treatment will switch to investigational drug after Week 24 to reduce the risk of lack of efficacy by placebo.

The primary outcome measures is proportion of patients whose hemorrhage has improved (clinical effective rate).

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, autoimmune thrombocytopenia
Treatment Placebo, Huaiqihuang Granule
Clinical Study IdentifierNCT03201848
SponsorQidong Gaitianli Medicines Co., Ltd
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged between 1 and 14 years (inclusive)
Is diagnosed as immune thrombocytopenia according to the criteria of ICD-10, i.e., platelet < 100109/L for at least two hematology tests with normal blood cell morphology; skin petechia, ecchymosis and (or) the clinical manifestations of mucosa and visceral hemorrhage; no splenomegaly; exclusion of other secondary thrombocytopenia, such as aplastic leukemia, aplastic anemia characterized by thrombocytopenia as the first hematologic abnormality, hereditary thrombocytopenia, thrombocytopenia secondary to other autoimmune diseases, infections or drugs etc
Meet the diagnosis criteria for Qi Yin deficiency in traditional Chinese medicine
Time since initial diagnosis of ITP until randomization is at least 12 month, i.e., course of disease 1 year
Values of prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) are within 1.2 times of normal reference range
Values of biochemistry parameters including creatinine, ALT, AST, glucose, total bilirubin are less than 1.2 time of the corresponding upper limit of normal range
Has signed and dated the informed consent in volunteer by the subject and the subject's legal guardian(s) (for subject who is less than 8 years old, the informed consent will be signed and dated by the subject's legal guardian(s) in volunteer)

Exclusion Criteria

Is diagnosed as congenital thrombocytopenia
Is diagnosed as secondary thrombocytopenia
Is diagnosed as non-immune thrombocytopenia
Has medical history of diabetes
In the judgement of Investigator, the subject is not appropriate to participate in this study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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