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

Gouty Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06068478
• Other study ID #: TSL-TCM-QZKL-?
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Rui Liu
• Phone: 022-86343626
• Email: liurui2[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 472
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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- a 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Gouty Arthritis

Intervention

Drug:
• Qingzhu Granules
During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily.
• Qingzhu Granules Placebo
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.

Locations

Country	Name	City	State
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	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

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Score (VAS)	Change from basline in Patient-assessed Pain Intensity on VAS at 24/48 hours.	24/48 hours
Secondary	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
Secondary	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
Secondary	CRP	Change from baseline in the inflammatory biomarkers CRP and at 72 hours.	72 hours
Secondary	Rescue medication	The total dose and frequency of rescue medication use within 72 hours of treatment.	72 hours
Secondary	Time interval	The interval between the first use of emergency medication and the first use of Investigational Product.	72 hours