A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial, Efficacy and Safety Study of Qingzhu Granules in the Treatment of Acute Gouty Arthritis ( Damp Heat Pattern)
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Male and female patients aged 18 to 70 years.
• Patient meeting the ACR/ EULAR 2015 gout classification criteria.
• Patient meeting the Damp heat Pattern identification of the traditional Chinese medicine.
• Onset of current flare within 48 hours.
• Patient-reported, current ongoing flare of gouty arthritis characterized by baseline pain intensity in the index joint of ≥40 mm on a 0-100 mm VAS.
• Signed informed consent to participate in this study.
Locations
Other Locations
China
Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
RECRUITING
Beijing
Binzhou Medical College Affiliated Hospital
RECRUITING
Binzhou
Bozhou People's Hospital
RECRUITING
Bozhou
Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
RECRUITING
Cangzhou
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
RECRUITING
Changsha
Dalian Central Hospital
RECRUITING
Dalian
The First Affiliated Hospital of Hainan Medical College
RECRUITING
Haikou
Hebei Provincial People's Hospital
RECRUITING
Hebei
The First Affiliated Hospital of South China University
RECRUITING
Hengyang
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
RECRUITING
Jinan
The First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Yunnan First People's Hospital
RECRUITING
Kunming
Yunnan Provincial Traditional Chinese Medicine Hospital
RECRUITING
Kunming
Gansu Provincial Hospital of Traditional Chinese Medicine
RECRUITING
Lanzhou
Gansu Provincial People's Hospital
RECRUITING
Lanzhou
Henan Province Luoyang Orthopedic Hospital
RECRUITING
Luoyang
Ma'anshan People's Hospital
RECRUITING
Ma’anshan
Mianyang Central Hospital
RECRUITING
Mianyang
Mianyang Traditional Chinese Medicine Hospital
RECRUITING
Mianyang
Pu'er People's Hospital
RECRUITING
Pu'er
Puyang Oilfield General Hospital
RECRUITING
Pujiang
Puyang People's Hospital
RECRUITING
Pujiang
Shiyan City People's Hospital
RECRUITING
Shiyan
Wenzhou People's Hospital
RECRUITING
Wenzhou
Xi'an Daxing Hospital
RECRUITING
Xi'an
Xiamen Traditional Chinese Medicine Hospital
RECRUITING
Xiamen
Xinxiang Central Hospital
RECRUITING
Xinxiang
Zhengzhou People's Hospital
RECRUITING
Zhengzhou
Hunan Province Directly Affiliated TCM Hospital
RECRUITING
Zhuzhou
Contact Information
Primary
Rui Liu
liurui2@tasly.com
022-86343626
Time Frame
Start Date: 2023-11-07
Estimated Completion Date: 2025-10
Participants
Target number of participants: 472
Treatments
Experimental: Qingzhu Granules
Placebo_comparator: Qingzhu Granules Placebo
Sponsors
Leads: Tasly Pharmaceutical Group Co., Ltd