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ACTIVE NOT RECRUITING
NCT03201848
PHASE4

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

Sponsor: Qidong Gaitianli Medicines Co., Ltd

View on ClinicalTrials.gov

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).

Official title: 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)

Key Details

Gender

All

Age Range

1 Year - 14 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2017-11-16

Completion Date

2024-06-30

Last Updated

2024-06-04

Healthy Volunteers

No

Interventions

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)

Locations (14)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, China

Wuhan Children's Hospital

Wuhan, Hubei, China

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Jiangxi Provincial Children's Hospital

Nanchang, Jiangxi, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Beijing Children's Hospital. Capital Medical University

Beijing, China

Children's Hospital Capital Institute of Pediatrics

Beijing, China

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, China