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This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qingzhu Granules | Experimental |
| |
| Qingzhu Granules Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qingzhu Granules | Drug | During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score (VAS) | Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score (VAS) | Change from basline in Patient-assessed Pain Intensity on VAS at 24/48 hours. | 24/48 hours |
| The total score of the Traditional Chinese Medicine Syndrome | Change from basline in the total score of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Province Luoyang Orthopedic Hospital | Luoyang | Henan | China | |||
| Xinxiang Central Hospital |
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| Qingzhu Granules Placebo | Drug | 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. |
|
| 72 hours |
| The each item score of the Traditional Chinese Medicine Syndrome | Change from basline in each item of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours. | 72 hours |
| CRP | Change from baseline in the inflammatory biomarkers CRP and at 72 hours. | 72 hours |
| Rescue medication | The total dose and frequency of rescue medication use within 72 hours of treatment. | 72 hours |
| Time interval | The interval between the first use of emergency medication and the first use of Investigational Product. | 72 hours |
| 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 |
| ID | Term |
|---|---|
| D015210 | Arthritis, Gouty |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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