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

Primary Purpose

Gouty Arthritis

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Qingzhu Granules
Qingzhu Granules Placebo
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gouty Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
  • Binzhou Medical College Affiliated Hospital
  • Bozhou People's Hospital
  • Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
  • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
  • Dalian Central Hospital
  • The First Affiliated Hospital of Hainan Medical College
  • Hebei Provincial People's Hospital
  • The First Affiliated Hospital of South China University
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Kunming Medical University
  • Yunnan First People's Hospital
  • Yunnan Provincial Traditional Chinese Medicine Hospital
  • Gansu Provincial Hospital of Traditional Chinese Medicine
  • Gansu Provincial People's Hospital
  • Ma'anshan People's Hospital
  • Mianyang Central Hospital
  • Mianyang Traditional Chinese Medicine Hospital
  • Pu'er People's Hospital
  • Puyang Oilfield General Hospital
  • Puyang People's Hospital
  • Shiyan City People's Hospital
  • Wenzhou People's Hospital
  • Xi'an Daxing Hospital
  • Xiamen Traditional Chinese Medicine Hospital
  • Hunan Province Directly Affiliated TCM Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Qingzhu Granules

Qingzhu Granules Placebo

Arm Description

Outcomes

Primary Outcome Measures

Visual Analogue Score (VAS)
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.

Secondary Outcome Measures

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

Full Information

First Posted
September 27, 2023
Last Updated
October 6, 2023
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06068478
Brief Title
A Study to Evaluate Efficacy and Safety of Qingzhu Granules in the Treatment of Acute Gouty Arthritis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gouty Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
472 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qingzhu Granules
Arm Type
Experimental
Arm Title
Qingzhu Granules Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Qingzhu Granules
Intervention Description
During the 72-hour treatment period, participants will receive 9 sacks of Qingzhu granules.Oral administration, 1 sack (6g) per time, 3 times daily.
Intervention Type
Drug
Intervention Name(s)
Qingzhu Granules Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Score (VAS)
Description
Change from basline in Patient-assessed Pain Intensity on VAS at 72 hours after the investigational product therapy.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Visual Analogue Score (VAS)
Description
Change from basline in Patient-assessed Pain Intensity on VAS at 24/48 hours.
Time Frame
24/48 hours
Title
The total score of the Traditional Chinese Medicine Syndrome
Description
Change from basline in the total score of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
Time Frame
72 hours
Title
The each item score of the Traditional Chinese Medicine Syndrome
Description
Change from basline in each item of the Traditional Chinese Medicine Syndrome Scoring Scale at 72 hours.
Time Frame
72 hours
Title
CRP
Description
Change from baseline in the inflammatory biomarkers CRP and at 72 hours.
Time Frame
72 hours
Title
Rescue medication
Description
The total dose and frequency of rescue medication use within 72 hours of treatment.
Time Frame
72 hours
Title
Time interval
Description
The interval between the first use of emergency medication and the first use of Investigational Product.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu
Phone
022-86343626
Email
liurui2@tasly.com
Facility Information:
Facility Name
Guang'anmen Hospital of the Chinese Academy of Traditional Chinese Medicine
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Jiang
Email
13901081632@163.com
Facility Name
Binzhou Medical College Affiliated Hospital
City
Binzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuebin Wang
Email
byfywxb@126.com
Facility Name
Bozhou People's Hospital
City
Bozhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhui Zhang
Email
clearhui1118@126.com
Facility Name
Hebei Cangzhou Integrated Traditional Chinese and Western Medicine Hospital
City
Cangzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxia Yu
Email
glxiaoxia@126.com
Facility Name
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
City
Changsha
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenzhi Wang
Email
wangshenzhi2006@126.com
Facility Name
Dalian Central Hospital
City
Dalian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinyu Li
Email
dlxinyuli1969@163.com
Facility Name
The First Affiliated Hospital of Hainan Medical College
City
Haikou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Li
Email
13834115767@163.com
Facility Name
Hebei Provincial People's Hospital
City
Hebei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Li
Email
yaoyaopangpang@sina.com
Facility Name
The First Affiliated Hospital of South China University
City
Hengyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daming Ou
Email
1197365840@qq.com
Facility Name
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
City
Jinan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Fan
Email
icii@163.com
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Zhang
Email
577811010@qq.com
Facility Name
Yunnan First People's Hospital
City
Kunming
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Fan
Email
fht7028@sina.cn
Facility Name
Yunnan Provincial Traditional Chinese Medicine Hospital
City
Kunming
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangyun Peng
Email
pengjiangyun@126.com
Facility Name
Gansu Provincial Hospital of Traditional Chinese Medicine
City
Lanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidong Wang
Email
943466210@qq.com
Facility Name
Gansu Provincial People's Hospital
City
Lanzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuhong Zhou
Email
zshlz1973@163.com
Facility Name
Ma'anshan People's Hospital
City
Ma'anshan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangliang Xie
Email
xiangliangxie@aliyun.com
Facility Name
Mianyang Central Hospital
City
Mianyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinyun Zou
Email
letter.zjm@163.com
Facility Name
Mianyang Traditional Chinese Medicine Hospital
City
Mianyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Zhong
Email
49802537@qq.com
Facility Name
Pu'er People's Hospital
City
Pu'er
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaoen Zheng
Email
zce163163@163.com
Facility Name
Puyang Oilfield General Hospital
City
Puyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengju Li
Email
13030300169@163.com
Facility Name
Puyang People's Hospital
City
Puyang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenjie Wang
Email
wangzhenjie321@sina.com
Facility Name
Shiyan City People's Hospital
City
Shiyan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Tao
Email
63886515@qq.com
Facility Name
Wenzhou People's Hospital
City
Wenzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suxian Lin
Email
13957741565@139.com
Facility Name
Xi'an Daxing Hospital
City
Xi'an
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Li
Email
Lyly0309@sina.com
Facility Name
Xiamen Traditional Chinese Medicine Hospital
City
Xiamen
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingshan Qiu
Email
18950153181@163.com
Facility Name
Hunan Province Directly Affiliated TCM Hospital
City
Zhuzhou
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuan Yao
Email
261763671@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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