NCT03201848

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

A Multisite, Randomized, Double-Blind, Placebo-Controlled, and Parallel Study to Evaluate the Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (Qi Yin Deficiency)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: Qidong Gaitianli Medicines Co., Ltd · Industry
• Sex: All
• Age: 1 Year – 14 Years
• Healthy volunteers: Not accepted

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).

Detailed 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).

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Placebo	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;) .
DRUG	Huaiqihuang Granule	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)

Timeline

• Start date: 2017-11-16
• Primary completion: 2023-10-14
• Completion: 2024-06-30
• First posted: 2017-06-28
• Last updated: 2024-06-04

Locations

14 sites across 1 country: China