Clinical trial NCT06068478: A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Gouty Arthritis
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)


Eligibility criteria: Inclusion Criteria:

1. Male and female patients aged 18 to 70 years.
2. Patient meeting the ACR/ EULAR 2015 gout classification criteria.
3. Patient meeting the Damp heat Pattern identification of the traditional Chinese medicine.
4. Onset of current flare within 48 hours.
5. 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.
6. Signed informed consent to participate in this study.

Exclusion Criteria:

1. Secondary gouty arthritis ( caused by other diseases or drugs).
2. The presence of pain symptoms caused by other diseases, as judged by the investigator, may have an impact on the safety or effectiveness evaluation.
3. 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.
4. Abnormal liver function (glutamic-oxaloacetic transaminase or glutamic-pyruvic transaminase\>2 ULN) or abnormal renal function (blood creatinine\>ULN).
5. 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.
6. Patients who have undergone uric acid lowering treatment but have not stably used uric acid lowering drugs within the 2 weeks prior to randomization.
7. 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.
8. 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.
9. Known allergies to the drug components of this study.
10. Contraindications to diclofenac sodium enteric coated tablets.
11. Men or women who have plans for conception within 3 months after the start to the end of the study.
12. Pregnant and lactating women.
13. Participated in other clinical trials within the past month.
14. Other situations that the investigator determines are not suitable for enrollment.

Primary outcomes:
measure: Visual Analogue Score (VAS)
timeFrame: 72 hours
Secondary outcomes:
measure: Visual Analogue Score (VAS)
timeFrame: 24/48 hours
measure: The total score of the Traditional Chinese Medicine Syndrome
timeFrame: 72 hours
measure: The each item score of the Traditional Chinese Medicine Syndrome
timeFrame: 72 hours
measure: CRP
timeFrame: 72 hours
measure: Rescue medication
timeFrame: 72 hours
measure: Time interval
timeFrame: 72 hours
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Henan Province Luoyang Orthopedic Hospital
state: Henan
city: Xinxiang
country: China
facility: Xinxiang Central Hospital
state: Henan
city: Beijing
country: China
facility: Guang&#39;anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
city: Binzhou
country: China
facility: Binzhou Medical College Affiliated Hospital
city: Bozhou
country: China
facility: Bozhou People&#39;s Hospital
city: Cangzhou
country: China
facility: Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
city: Changsha
country: China
facility: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
city: Dalian
country: China
facility: Dalian Central Hospital
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical College
city: Hebei
country: China
facility: Hebei Provincial People&#39;s Hospital
city: Hengyang
country: China
facility: The First Affiliated Hospital of South China University
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
city: Kunming
country: China
facility: Yunnan First People&#39;s Hospital
city: Kunming
country: China
facility: Yunnan Provincial Traditional Chinese Medicine Hospital
city: Lanzhou
country: China
facility: Gansu Provincial Hospital of Traditional Chinese Medicine
city: Lanzhou
country: China
facility: Gansu Provincial People&#39;s Hospital
city: Ma'anshan
country: China
facility: Ma'anshan People's Hospital
city: Mianyang
country: China
facility: Mianyang Central Hospital
city: Mianyang
country: China
facility: Mianyang Traditional Chinese Medicine Hospital
city: Pu'er
country: China
facility: Pu'er People&#39;s Hospital
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
city: Puyang
country: China
facility: Puyang People&#39;s Hospital
city: Shiyan
country: China
facility: Shiyan City People&#39;s Hospital
city: Wenzhou
country: China
facility: Wenzhou People&#39;s Hospital
city: Xi'an
country: China
facility: Xi'an Daxing Hospital
city: Xiamen
country: China
facility: Xiamen Traditional Chinese Medicine Hospital
city: Zhengzhou
country: China
facility: Zhengzhou People's Hospital
city: Zhuzhou
country: China
facility: Hunan Province Directly Affiliated TCM Hospital
Study officials:
References: