Quzhuo tongbi formula for reducing gout flare related to uric acid lowering treatment: Study protocol for a multiple-center, randomized, double-blind, placebo, parallel-controlled clinical trial

Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout...

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Published inPloS one Vol. 20; no. 7; p. e0327864
Main Authors Pan, Hejing, Li, Xuanlin, Wu, Shan, Zhou, Donghai, Guan, Haojie, Wu, Haoyu, Wang, Qiao, Tang, Yujun, Hu, Xuanming, Wang, Meijiao, Zhou, Mingqian, Huang, Runyue, Liu, Lei, Chen, Yaolong, Wen, Chengping, Huang, Lin
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 09.07.2025
Public Library of Science (PLoS)
Subjects
Adolescent
Adult
Aged
Aged, 80 and over
Arthritis
Blood
Care and treatment
Causes of
China
Clinical trials
Compliance
Computer and Information Sciences
Consent
Crystals
Disease
Double-Blind Method
Drug dosages
Drug withdrawal
Drugs, Chinese Herbal - therapeutic use
Effectiveness
Electrocardiography
Evaluation
Febuxostat - therapeutic use
Female
Flares
Gout
Gout - blood
Gout - drug therapy
Gout Suppressants - therapeutic use
Health services
Hospitals
Humans
Hyperuricemia
Hyperuricemia - drug therapy
Laboratory tests
Male
Medicine and Health Sciences
Medicine, Chinese
Middle Aged
Multicenter Studies as Topic
Patients
Physical Sciences
Placebos
Prevention
Randomized Controlled Trials as Topic
Research and Analysis Methods
Rheumatic diseases
Rheumatism
Side effects
Steroids
Study Protocol
Traditional Chinese medicine
Uric acid
Uric Acid - blood
Young Adult
China
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Abstract Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT. This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored. The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT. ChiCTR20084417 Register on May 16, 2024.
AbstractList Introduction Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT. Method This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18–80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient’s enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale – VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored. Discussion The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT. Trial registration ChiCTR20084417 Register on May 16, 2024.
Introduction Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT. Method This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored. Discussion The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT. Trial registration ChiCTR20084417 Register on May 16, 2024.
Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT. This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored. The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT.
Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT.INTRODUCTIONGout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT.This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored.METHODThis is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored.The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT.DISCUSSIONThe findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT.ChiCTR20084417 Register on May 16, 2024.TRIAL REGISTRATIONChiCTR20084417 Register on May 16, 2024.
IntroductionGout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT.MethodThis is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18–80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient’s enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale – VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored.DiscussionThe findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT.Trial registrationChiCTR20084417 Register on May 16, 2024.
Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with hyperuricemia. Long-term or lifelong urate-lowering therapy (ULT) stands as the primary management strategy. However, there is a significant risk of gout flares during ULT, and current methods have drawbacks, including side effects. Previous research has suggested a potential benefit of the Qu-zhuo Tong-bi formula (QTF) in the treatment and prevention of gout. This study aims to evaluate the effectiveness and safety of QTF in reducing gout flares during ULT. This is a multi-center, randomized, double-blind, placebo, parallel-controlled clinical trial conducted in four hospitals in Zhejiang Province, China. A total of 144 patients, aged 18-80 years, will be randomly allocated to either the intervention group (QTF + febuxostat) or the control group (placebo + febuxostat) for a 12-week treatment period. The primary outcome measure is the frequency of gout flares. Secondary outcome measures include the time from the patient's enrollment to the first occurrence of gout flare (in days), duration of gout flare (in days), health assessment questionnaire disability index (HAQ-DI), pain level (visual analog scale - VAS), rate of achieving target uric acid levels. Occurrences of adverse events, and results from electrocardiograms and laboratory tests, will be monitored. The findings from this study will offer valuable evidence supporting the efficacy of the QTF in reducing gout flares during ULT. ChiCTR20084417 Register on May 16, 2024.
Audience Academic
Author Tang, Yujun
Wang, Meijiao
Chen, Yaolong
Wen, Chengping
Zhou, Mingqian
Huang, Runyue
Pan, Hejing
Wu, Shan
Zhou, Donghai
Liu, Lei
Hu, Xuanming
Li, Xuanlin
Guan, Haojie
Wang, Qiao
Wu, Haoyu
Huang, Lin
AuthorAffiliation 6 the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
2 the First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
7 Department of Rheumatology and Immunology, the Second Affiliated Hospital of Zhejiang University, Hangzhou, China
8 Center for Evidence-Based Medicine, Lanzhou University, Lanzhou, China
1 College of Basic Medical Science, Zhejiang Chinese Medical University, Hangzhou, China
5 Huzhou Hospital of Traditional Chinese Medicine, Huzhou, China
University of Illinois, UNITED STATES OF AMERICA
4 Shengzhou People’s Hospital, Shengzhou, China
3 the Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/40632763$$D View this record in MEDLINE/PubMed
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Copyright Copyright: © 2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
2025 Pan et al 2025 Pan et al
2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
Copyright_xml – notice: Copyright: © 2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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– notice: 2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
– notice: 2025 Pan et al 2025 Pan et al
– notice: 2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.
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License Copyright: © 2025 Pan et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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Snippet Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with...
Introduction Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with...
IntroductionGout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with...
Introduction Gout, a prevalent metabolic rheumatic disease, arises from the accumulation of monosodium urate (MSU) crystals in joints, directly associated with...
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SubjectTerms Adolescent
Adult
Aged
Aged, 80 and over
Arthritis
Blood
Care and treatment
Causes of
China
Clinical trials
Compliance
Computer and Information Sciences
Consent
Crystals
Disease
Double-Blind Method
Drug dosages
Drug withdrawal
Drugs, Chinese Herbal - therapeutic use
Effectiveness
Electrocardiography
Evaluation
Febuxostat - therapeutic use
Female
Flares
Gout
Gout - blood
Gout - drug therapy
Gout Suppressants - therapeutic use
Health services
Hospitals
Humans
Hyperuricemia
Hyperuricemia - drug therapy
Laboratory tests
Male
Medicine and Health Sciences
Medicine, Chinese
Middle Aged
Multicenter Studies as Topic
Patients
Physical Sciences
Placebos
Prevention
Randomized Controlled Trials as Topic
Research and Analysis Methods
Rheumatic diseases
Rheumatism
Side effects
Steroids
Study Protocol
Traditional Chinese medicine
Uric acid
Uric Acid - blood
Young Adult
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Title Quzhuo tongbi formula for reducing gout flare related to uric acid lowering treatment: Study protocol for a multiple-center, randomized, double-blind, placebo, parallel-controlled clinical trial
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