A Phase 4 interventional study of Placebo and Huaiqihuang Granule in Immune Thrombocytopenia, sponsored by Qidong Gaitianli Medicines Co., Ltd. Active, not recruiting at 14 sites in China. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Qidong Gaitianli Medicines Co., Ltd · Phase 4, Interventional, and Treatment
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).
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).
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 216 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Qidong Gaitianli Medicines Co., Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Huaiqihuang Granule given to subject will be adjusted by body weight with treatment duration for 48 weeks
Drug: Huaiqihuang Granule
Placebo given to subject will be adjusted by body weight After 24 weeks of placebo, change to Huaiqihuang Granule for another 24 weeks.
Drug: Placebo · Drug: Huaiqihuang Granule
Placebo given to subject will be adjusted by body weight (\<10kg, Placebo given to subject will be adjusted by body weight(\<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day;) .
Huaiqihuang Granule given to subject will be adjusted by body weight (\<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day)
Also known as: Huaiqihuang
the proportion of subjects whose hemorrhage has improved (clinical effective rate)
The improvement of hemorrhage is defined if at least one of the following criteria is met: 1. Severity of hemorrhage decreases one or more grade, the severity of hemorrhage is defined as following: none: there is any hemorrhage manifestation; mild: simple (often related with an unnoticeable minor collision without obvious ecchymosis) or obvious ecchymosis by collision; moderate: mucous membrane hemorrhage (nose hemorrhage, gum, oral mucosa) and menorrhagia; and severe: organ hemorrhage (digestive tract, respiratory tract, intracranial, etc.). 2. Significant increase in platelet count defined as platelet count is over 30×109/L and increases more than twice compared with the baseline. The results must be tested at least twice with at least 7 days apart). 3. The score of quality of life improves one or more points.
Time frame: 24、48 and 60 Weeks after treatment
the recovery rate of immune function
The recovery rate of immune function is the proportion of subjects who have normalized immune function after treatment. The parameters of immune function include cytokines, lymphocyte subsets and auto immunity. One of the three tests has been restored to normal is defined as the immune function has returned to normal.
Time frame: 24、48 and 60 Weeks after treatment
the recovery rate of thyroid function
The recovery rate of thyroid function is the proportion of subjects who have normalized immune function after treatment.
Time frame: 12、24、36、48、60 and 72 Weeks after treatment
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Qidong Gaitianli Medicines Co., Ltd