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

February 25, 2026 updated by: Tasly Pharmaceutical Group Co., Ltd

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
472

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Qingzhu Granules
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.
Placebo Comparator: Qingzhu Granules Placebo
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Score (VAS)
Time Frame: 24/48 hours
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
Time Frame: 72 hours
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
Time Frame: 72 hours
Change from basline in each item of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
72 hours
CRP
Time Frame: 72 hours
Change from baseline in the inflammatory biomarkers CRP and at 72 hours.
72 hours
Rescue medication
Time Frame: 72 hours
The total dose and frequency of rescue medication use within 72 hours of treatment.
72 hours
Time interval
Time Frame: 72 hours
The interval between the first use of emergency medication and the first use of Investigational Product.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tasly Pharmaceutical Group Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TSL-TCM-QZKL-Ⅲ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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