Gouty ArthritisPhase 3NCT06068478
A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
A Phase 3 study testing Qingzhu Granules in people with Gouty Arthritis, run by Tasly Pharmaceutical Group Co., Ltd at 29 sites in China.
Trial summary
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gouty Arthritis
- What is being tested?
- Qingzhu Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 29 sitesChina
- Study dates
- 7 Nov 2023to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
Beijing
Binzhou Medical College Affiliated Hospital
Binzhou
Bozhou People's Hospital
Bozhou
Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
Cangzhou
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Changsha
Dalian Central Hospital
Dalian
The First Affiliated Hospital of Hainan Medical College
Haikou
Hebei Provincial People's Hospital
Hebei
The First Affiliated Hospital of South China University
Hengyang
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan
The First Affiliated Hospital of Kunming Medical University
Kunming
Yunnan First People's Hospital
Kunming
Yunnan Provincial Traditional Chinese Medicine Hospital
Kunming
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou
Gansu Provincial People's Hospital
Lanzhou
Henan Province Luoyang Orthopedic Hospital
Luoyang, Henan
Ma'anshan People's Hospital
Ma’anshan
Mianyang Central Hospital
Mianyang
Mianyang Traditional Chinese Medicine Hospital
Mianyang
Pu'er People's Hospital
Pu'er
Puyang Oilfield General Hospital
Pujiang
Puyang People's Hospital
Pujiang
Shiyan City People's Hospital
Shiyan
Wenzhou People's Hospital
Wenzhou
Xi'an Daxing Hospital
Xi'an
Xiamen Traditional Chinese Medicine Hospital
Xiamen
Xinxiang Central Hospital
Xinxiang, Henan
Zhengzhou People's Hospital
Zhengzhou
Hunan Province Directly Affiliated TCM Hospital
Zhuzhou
About this study
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)
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
- Conditions
- Gouty Arthritis
- Being tested
- Qingzhu Granules, Qingzhu Granules Placebo
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qingzhu GranulesDrug
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 PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Qingzhu Granules | Experimental | Not described Receives: Drug: Qingzhu Granules |
| Qingzhu Granules Placebo | Placebo comparator | Not described Receives: Drug: Qingzhu Granules Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score (VAS)
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
Measured: 72 hours
Secondary outcomes (6)
Visual Analogue Score (VAS)
Change from basline in Patient-assessed Pain Intensity on VAS at 24/48 hours.
Measured: 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.
Measured: 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.
Measured: 72 hours
CRP
Change from baseline in the inflammatory biomarkers CRP and at 72 hours.
Measured: 72 hours
Rescue medication
The total dose and frequency of rescue medication use within 72 hours of treatment.
Measured: 72 hours
Time interval
The interval between the first use of emergency medication and the first use of Investigational Product.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start7 Nov 2023
- Primary completion2 Apr 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gouty ArthritisStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068478
- Sponsor's protocol ID
- TSL-TCM-QZKL-Ⅲ
- Status last verified
- Feb 2026
- First submitted
- 27 Sep 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou X, Lian F, Zhao T, Jiang Q, Zhao Y. Efficacy and safety of Qing Zhu Granules for acute gouty arthritis with dampness-heat obstruction syndrome: study protocol for a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2026 Jul 28;13:1839780. doi: 10.3389/fmed.2026.1839780. eCollection 2026.
PubMed 42582081
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06068478
- Acronym / sponsor ID
- TSL-TCM-QZKL-Ⅲ
- Conditions
- Gouty Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of Qingzhu Granules in the treatment of Acute Gouty Arthritis ( Damp heat pattern)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qingzhu Granules | Experimental | Drug: Qingzhu Granules |
| Qingzhu Granules Placebo | Placebo comparator | Drug: Qingzhu Granules Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qingzhu GranulesDuring the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily. | Drug | Qingzhu Granules |
| Qingzhu Granules PlaceboDuring the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules Placebo.Oral administration, 1 sack (6g) per time, 3 times daily. | Drug | Qingzhu Granules Placebo |
Primary outcome
Visual Analogue Score (VAS)
Time frame: 72 hours
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
6 secondary outcomes
Visual Analogue Score (VAS)
Time frame: 24/48 hours
The total score of the Traditional Chinese Medicine Syndrome
Time frame: 72 hours
The each item score of the Traditional Chinese Medicine Syndrome
Time frame: 72 hours
CRP
Time frame: 72 hours
Rescue medication
Time frame: 72 hours
Time interval
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 42582081Zhou X, Lian F, Zhao T, Jiang Q, Zhao Y. Efficacy and safety of Qing Zhu Granules for acute gouty arthritis with dampness-heat obstruction syndrome: study protocol for a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2026 Jul 28;13:1839780. doi: 10.3389/fmed.2026.1839780. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Qingzhu Granules in people with Gouty Arthritis, run by Tasly Pharmaceutical Group Co., Ltd at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06068478, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.