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

October 6, 2023 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

472

Phase

  • 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 Locations

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

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

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
Intervention / Treatment
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

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

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

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 (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

September 27, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

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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