A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
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)
1 other identifier
interventional
472
1 country
29
Brief Summary
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2023
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedStudy Start
First participant enrolled
November 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedFebruary 27, 2026
February 1, 2026
1.4 years
September 27, 2023
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Score (VAS)
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
72 hours
Secondary Outcomes (6)
Visual Analogue Score (VAS)
24/48 hours
The total score of the Traditional Chinese Medicine Syndrome
72 hours
The each item score of the Traditional Chinese Medicine Syndrome
72 hours
CRP
72 hours
Rescue medication
72 hours
- +1 more secondary outcomes
Study Arms (2)
Qingzhu Granules
EXPERIMENTALQingzhu Granules Placebo
PLACEBO COMPARATORInterventions
During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily.
During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules Placebo.Oral administration, 1 sack (6g) per time, 3 times daily.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Secondary gouty arthritis ( caused by other diseases or drugs).
- The presence of pain symptoms caused by other diseases, as judged by the investigator, may have an impact on the safety or effectiveness evaluation.
- If there are severe motor, digestive, respiratory, urological, reproductive, endocrine, immune, neurological, circulatory, or psychiatric disorders, the investigator may determine that it may have an impact on the safety or effectiveness evaluation.
- Abnormal liver function (glutamic-oxaloacetic transaminase or glutamic-pyruvic transaminase\>2 ULN) or abnormal renal function (blood creatinine\>ULN).
- People who are not eligible for VAS evaluation, such as those with severe impairment of abstract ability, visual and writing function, and those who have taken sedatives.
- Patients who have undergone uric acid lowering treatment but have not stably used uric acid lowering drugs within the 2 weeks prior to randomization.
- After this gout attack, traditional Chinese medicine, chemical drugs (including but not limited to colchicine, glucocorticoids, and adrenocorticotropins), biological drugs (including but not limited to IL-1 and TNF- α Inhibitor) ,and non drug treatment (including but not limited to acupuncture and moxibustion and topical ice)that have therapeutic effects on gout have been used.
- After this gout attack, non-steroidal anti-inflammatory drugs (including but not limited to aspirin, acetaminophen, losoprofen, ibuprofen, and diclofenac sodium) have been used, and the medication duration is within 5 half-lives of the drug.
- Known allergies to the drug components of this study.
- Contraindications to diclofenac sodium enteric coated tablets.
- Men or women who have plans for conception within 3 months after the start to the end of the study.
- Pregnant and lactating women.
- Participated in other clinical trials within the past month.
- Other situations that the investigator determines are not suitable for enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Henan Province Luoyang Orthopedic Hospital
Luoyang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
Beijing, China
Binzhou Medical College Affiliated Hospital
Binzhou, China
Bozhou People's Hospital
Bozhou, China
Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
Cangzhou, China
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, China
Dalian Central Hospital
Dalian, China
The First Affiliated Hospital of Hainan Medical College
Haikou, China
Hebei Provincial People's Hospital
Hebei, China
The First Affiliated Hospital of South China University
Hengyang, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, China
Yunnan First People's Hospital
Kunming, China
Yunnan Provincial Traditional Chinese Medicine Hospital
Kunming, China
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, China
Gansu Provincial People's Hospital
Lanzhou, China
Ma'anshan People's Hospital
Ma’anshan, China
Mianyang Central Hospital
Mianyang, China
Mianyang Traditional Chinese Medicine Hospital
Mianyang, China
Pu'er People's Hospital
Pu'er, China
Puyang Oilfield General Hospital
Pujiang, China
Puyang People's Hospital
Pujiang, China
Shiyan City People's Hospital
Shiyan, China
Wenzhou People's Hospital
Wenzhou, China
Xi'an Daxing Hospital
Xi'an, China
Xiamen Traditional Chinese Medicine Hospital
Xiamen, China
Zhengzhou People's Hospital
Zhengzhou, China
Hunan Province Directly Affiliated TCM Hospital
Zhuzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 5, 2023
Study Start
November 7, 2023
Primary Completion
April 2, 2025
Study Completion
December 30, 2025
Last Updated
February 27, 2026
Record last verified: 2026-02