Active — Not RecruitingPhase 4

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

China216 participantsStarted 2017-11-16

Plain-language 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).

Who can participate

Age range1 Year – 14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female, aged between 1 and 14 years (inclusive) ;

Exclusion criteria

✕. 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).
✕. Is diagnosed as congenital thrombocytopenia;
✕. Is diagnosed as secondary thrombocytopenia;
✕. Is diagnosed as non-immune thrombocytopenia;

What they're measuring

the proportion of subjects whose hemorrhage has improved (clinical effective rate)

Timeframe: 24、48 and 60 Weeks after treatment

Trial details

NCT IDNCT03201848

SponsorQidong Gaitianli Medicines Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-14

View on ClinicalTrials.gov More Immune Thrombocytopenia trials