A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis

Study Overview
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Brief Summary
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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)

Official Title
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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)

Conditions
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Gouty Arthritis

Intervention / Treatment
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* Drug: Qingzhu Granules
* Drug: Qingzhu Granules Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qingzhu Granules<br> | Drug: Qingzhu Granules<br>* During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily.<br>|
| Placebo Comparator: Qingzhu Granules Placebo<br> | Drug: Qingzhu Granules Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |