Herbal gout treatment shows promise in large trial
NCT ID NCT06068478
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tested whether Qingzhu Granules, a traditional Chinese herbal medicine, can reduce pain from acute gouty arthritis. 472 adults with a gout flare took either the granules or a placebo for 72 hours. The main goal was to see if pain scores improved more with the real treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Qingzhu Granules (a traditional Chinese medicine herbal formula)
- What this could lead to
- If it works, this could provide a new, well-tested herbal option for quickly easing pain during gout flares.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet published. The herbal formula may not prove more effective than placebo, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
472 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
-
Dec 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gouty arthritis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, China
-
Binzhou Medical College Affiliated Hospital
Binzhou, China
-
Bozhou People's Hospital
Bozhou, China
-
Dalian Central Hospital
Dalian, China
-
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, China
-
Gansu Provincial People's Hospital
Lanzhou, China
-
Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
Beijing, China
-
Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
Cangzhou, China
-
Hebei Provincial People's Hospital
Hebei, China
-
Henan Province Luoyang Orthopedic Hospital
Luoyang, Henan, China
-
Hunan Province Directly Affiliated TCM Hospital
Zhuzhou, 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
-
The First Affiliated Hospital of Hainan Medical College
Haikou, China
-
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha, China
-
The First Affiliated Hospital of Kunming Medical University
Kunming, China
-
The First Affiliated Hospital of South China University
Hengyang, China
-
Wenzhou People's Hospital
Wenzhou, China
-
Xi'an Daxing Hospital
Xi'an, China
-
Xiamen Traditional Chinese Medicine Hospital
Xiamen, China
-
Xinxiang Central Hospital
Xinxiang, Henan, China
-
Yunnan First People's Hospital
Kunming, China
-
Yunnan Provincial Traditional Chinese Medicine Hospital
Kunming, China
-
Zhengzhou People's Hospital
Zhengzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.