A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
- Conditions
- Gouty Arthritis
- Interventions
- Drug: Qingzhu Granules Placebo
- Registration Number
- NCT06068478
- Lead Sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Brief Summary
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 472
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Qingzhu Granules Qingzhu Granules - Qingzhu Granules Placebo Qingzhu Granules Placebo -
- Primary Outcome Measures
Name Time Method Visual Analogue Score (VAS) 72 hours Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
- Secondary Outcome Measures
Name Time Method Visual Analogue Score (VAS) 24/48 hours Change from basline in Patient-assessed Pain Intensity on VAS at 24/48 hours.
The total score of the Traditional Chinese Medicine Syndrome 72 hours Change from basline in the total score of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
The each item score of the Traditional Chinese Medicine Syndrome 72 hours Change from basline in each item of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
Rescue medication 72 hours The total dose and frequency of rescue medication use within 72 hours of treatment.
CRP 72 hours Change from baseline in the inflammatory biomarkers CRP and at 72 hours.
Time interval 72 hours The interval between the first use of emergency medication and the first use of Investigational Product.
Trial Locations
- Locations (29)
Henan Province Luoyang Orthopedic Hospital
🇨🇳Luoyang, Henan, China
Xinxiang Central Hospital
🇨🇳Xinxiang, Henan, China
Zhengzhou People's Hospital
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
🇨🇳Puyang, China
Puyang People's Hospital
🇨🇳Puyang, 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
Hunan Province Directly Affiliated TCM Hospital
🇨🇳Zhuzhou, China