Evaluating Qingzhu Granules for treating 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)

This study is testing if Qingzhu Granules can help people with acute gouty arthritis feel better compared to a placebo.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 472 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Tasly Pharmaceutical Group Co., Ltd (industry)
• Locations: 29 sites (Luoyang, Henan and 28 other locations)
• Trial ID: NCT06068478 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of Qingzhu Granules in patients suffering from acute gouty arthritis characterized by a Damp heat pattern. Participants will be randomly assigned to receive either the Qingzhu Granules or a placebo. The study will focus on patients who have experienced a gout flare within the last 48 hours and have a specific pain intensity level. The evaluation will be based on established gout classification criteria and patient-reported outcomes.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 70 who meet specific gout classification criteria and have a current flare of gouty arthritis.

Not a fit: Patients with secondary gouty arthritis or those whose pain is attributed to other diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing acute gouty arthritis.

How similar studies have performed: While this approach is based on traditional Chinese medicine, similar studies evaluating herbal treatments for gout have shown varying degrees of success.

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.

Where this trial is running

Luoyang, Henan and 28 other locations

• Henan Province Luoyang Orthopedic Hospital — Luoyang, Henan, China (RECRUITING)
• Xinxiang Central Hospital — Xinxiang, Henan, China (RECRUITING)
• Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine — Beijing, China (RECRUITING)
• Binzhou Medical College Affiliated Hospital — Binzhou, China (RECRUITING)
• Bozhou People's Hospital — Bozhou, China (RECRUITING)
• Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital — Cangzhou, China (RECRUITING)
• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine — Changsha, China (RECRUITING)
• Dalian Central Hospital — Dalian, China (RECRUITING)
• The First Affiliated Hospital of Hainan Medical College — Haikou, China (RECRUITING)
• Hebei Provincial People's Hospital — Hebei, China (RECRUITING)
• The First Affiliated Hospital of South China University — Hengyang, China (RECRUITING)
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, China (RECRUITING)
• The First Affiliated Hospital of Kunming Medical University — Kunming, China (RECRUITING)
• Yunnan First People's Hospital — Kunming, China (RECRUITING)
• Yunnan Provincial Traditional Chinese Medicine Hospital — Kunming, China (RECRUITING)
• Gansu Provincial Hospital of Traditional Chinese Medicine — Lanzhou, China (RECRUITING)
• Gansu Provincial People's Hospital — Lanzhou, China (RECRUITING)
• Ma'anshan People's Hospital — Ma'anshan, China (RECRUITING)
• Mianyang Central Hospital — Mianyang, China (RECRUITING)
• Mianyang Traditional Chinese Medicine Hospital — Mianyang, China (RECRUITING)
• Pu'er People's Hospital — Pu'er, China (RECRUITING)
• Puyang Oilfield General Hospital — Puyang, China (RECRUITING)
• Puyang People's Hospital — Puyang, China (RECRUITING)
• Shiyan City People's Hospital — Shiyan, China (RECRUITING)
• Wenzhou People's Hospital — Wenzhou, China (RECRUITING)
• Xi'an Daxing Hospital — Xi'an, China (RECRUITING)
• Xiamen Traditional Chinese Medicine Hospital — Xiamen, China (RECRUITING)
• Hunan Province Directly Affiliated TCM Hospital — Zhuzhou, China (RECRUITING)
• Zhengzhou People's Hospital (RECRUITING)

Study contacts

• Study coordinator: Rui Liu

Conditions: Gouty Arthritis