{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T05:00:09Z","timestamp":1785214809348,"version":"3.55.0"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Innovation Team of Science and Technology Innovation Project of China Academy of Chinese Medical Sciences - Rheumatology Team of Traditional Chinese Medicine Science and Technology Innovation","award":["CI2021B007"],"award-info":[{"award-number":["CI2021B007"]}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:p>Although standard therapies for acute gouty arthritis, such as nonsteroidal anti-inflammatory drugs, colchicine, and glucocorticoids demonstrate efficacy, their clinical application is limited by potential adverse reactions, which remains an unresolved issue. Qing Zhu Granules is a traditional Chinese medicine (TCM) compound preparation used for the treatment of primary acute gouty arthritis with dampness-heat obstruction syndrome. This multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial conducted in China aimed to evaluate the efficacy and safety of Qing Zhu Granules. Patients who met the Western medical diagnostic criteria for gout, met the TCM syndrome differentiation criteria for dampness-heat obstruction syndrome, had an acute attack duration \u226448\u202fh, and a visual analog scale (VAS) score of joint pain \u2265 40\u202fmm in the current attack were included. Participants were randomly assigned in a 1:1 ratio to the Qing Zhu Granules group or the placebo group, with an oral dose of 6\u202fg, administered 3 times a day, for a treatment course of 3\u202fdays. During the treatment period, diclofenac sodium enteric-coated tablets could be used as rescue medication in case of intolerable pain. The primary endpoint was the change in joint pain VAS score (0\u2013100\u202fmm) from baseline at 72\u202fh after treatment. The secondary endpoints included changes in joint pain VAS score from baseline at 24 and 48\u202fh after treatment, changes in the total score and each individual item score of the TCM syndrome rating scale from baseline, changes in C-reactive protein levels from baseline at 72\u202fh after treatment, total dose and frequency of rescue medication within 72\u202fh of treatment, and the interval between the first use of rescue medication and the first use of the study drug after treatment initiation.<\/jats:p>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/clinicaltrials.gov\/<\/jats:ext-link>\n                      , identifier NCT06068478.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1839780","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T04:25:52Z","timestamp":1785212752000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.3389","volume":"13","author":[{"given":"Xinyao","family":"Zhou","sequence":"first","affiliation":[{"name":"Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fengmei","family":"Lian","sequence":"additional","affiliation":[{"name":"GCP Office, Guang'anmen Hospital, China Academy of Chinese Medical Sciences","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ting","family":"Zhao","sequence":"additional","affiliation":[{"name":"GCP Office, Guang'anmen Hospital, China Academy of Chinese Medical Sciences","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quan","family":"Jiang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Zhao","sequence":"additional","affiliation":[{"name":"Department of Rheumatology and Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","place":["Beijing, China"]},{"name":"National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID)","place":["Beijing, China"]},{"name":"State Key Laboratory of Complex Severe and Rare Diseases","place":["Beijing, China"]},{"name":"Key Laboratory of Rheumatology and Immuno-disease, Ministry of Education","place":["Beijing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,7,28]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"380","DOI":"10.1038\/s41584-020-0441-1","article-title":"Global epidemiology of gout: prevalence, incidence, treatment patterns and risk factors","volume":"16","author":"Dehlin","year":"2020","journal-title":"Nat Rev Rheumatol"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"421","DOI":"10.3760\/cma.j.cn112138-20200327-00306","article-title":"Recommendations of diagnosis and treatment of gout in China","volume":"59","author":"Xu","year":"2020","journal-title":"Zhonghua Nei Ke Za Zhi"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"154","DOI":"10.1007\/s11926-009-0022-4","article-title":"Quality of life and quality of care for patients with 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