Yikun He, Jiaying Shen, Huihui Wu, Lan Chen, Qian Zhou, Qi Wang, Yafang Guo, Fan Wu, Xin Pan
{"title":"补肾解毒通络汤治疗活动性类风湿关节炎的疗效和安全性：一项多中心、随机、双盲、对照试验研究方案。","authors":"Yikun He, Jiaying Shen, Huihui Wu, Lan Chen, Qian Zhou, Qi Wang, Yafang Guo, Fan Wu, Xin Pan","doi":"10.2147/JPR.S512681","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Among the currently available therapeutic agents, methotrexate (MTX) is an internationally recognized first-line disease-modifying antirheumatic drug (DMARD) for RA and is widely used as a basic drug in combination therapies. The Bushen Jiedu Tongluo Decoction (BSJDTL), an herbal formula, has been used for the treatment of RA for more than ten years with a better curative effect. Therefore, we designed a multi-center, randomized, double-blind, placebo-controlled study, to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA.</p><p><strong>Methods: </strong>This was a multi-center, randomized, double-blind placebo-controlled trial. A total of 120 adult participants with active RA will be enrolled, with a balanced treatment allocation (1:1). The treatment intervention will be BSJDTL plus the conventional medicine methotrexate, and the control intervention will be placebo plus the conventional drug methotrexate for 24 weeks. In addition, both groups received folic acid during treatment to prevent side effects of methotrexate. The primary outcome was DAS28-ESR. Secondary outcomes included changes in joint symptoms and signs, ESR, CRP, MIF, MMP2, CD147, ICAM-1, VCAM-1, and HIF-1α levels, and joint evaluation via musculoskeletal ultrasound and X-ray.</p><p><strong>Discussion: </strong>We designed this multi-center, randomized, double-blind, placebo-controlled clinical trial, utilizing assessment of RA activity and imaging techniques (musculoskeletal ultrasound and X-ray) to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA. The results of this trial may provide insights into improving the clinical symptoms of patients with RA. We hope that this trial will provide preliminary evidence of the efficacy of BSJDTL in treating RA patients and that these results will aid researchers, practitioners, and patients alike.</p><p><strong>Aim: </strong>This study aimed to clarify the efficacy and safety of BSJDTL in patients with active RA.</p><p><strong>Trial registration: </strong>International Traditional Medicine Clinical Trial Registry, ITMCTR2025000194.</p>","PeriodicalId":16661,"journal":{"name":"Journal of Pain Research","volume":"18 ","pages":"3477-3491"},"PeriodicalIF":2.5000,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12258239/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Bushen Jiedu Tongluo Decoction in Active Rheumatoid Arthritis: Study Protocol for a Multi-Center, Randomized, Double-Blind, Controlled Trial.\",\"authors\":\"Yikun He, Jiaying Shen, Huihui Wu, Lan Chen, Qian Zhou, Qi Wang, Yafang Guo, Fan Wu, Xin Pan\",\"doi\":\"10.2147/JPR.S512681\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Among the currently available therapeutic agents, methotrexate (MTX) is an internationally recognized first-line disease-modifying antirheumatic drug (DMARD) for RA and is widely used as a basic drug in combination therapies. The Bushen Jiedu Tongluo Decoction (BSJDTL), an herbal formula, has been used for the treatment of RA for more than ten years with a better curative effect. Therefore, we designed a multi-center, randomized, double-blind, placebo-controlled study, to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA.</p><p><strong>Methods: </strong>This was a multi-center, randomized, double-blind placebo-controlled trial. A total of 120 adult participants with active RA will be enrolled, with a balanced treatment allocation (1:1). The treatment intervention will be BSJDTL plus the conventional medicine methotrexate, and the control intervention will be placebo plus the conventional drug methotrexate for 24 weeks. In addition, both groups received folic acid during treatment to prevent side effects of methotrexate. The primary outcome was DAS28-ESR. Secondary outcomes included changes in joint symptoms and signs, ESR, CRP, MIF, MMP2, CD147, ICAM-1, VCAM-1, and HIF-1α levels, and joint evaluation via musculoskeletal ultrasound and X-ray.</p><p><strong>Discussion: </strong>We designed this multi-center, randomized, double-blind, placebo-controlled clinical trial, utilizing assessment of RA activity and imaging techniques (musculoskeletal ultrasound and X-ray) to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA. The results of this trial may provide insights into improving the clinical symptoms of patients with RA. 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Efficacy and Safety of Bushen Jiedu Tongluo Decoction in Active Rheumatoid Arthritis: Study Protocol for a Multi-Center, Randomized, Double-Blind, Controlled Trial.
Introduction: Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease with the primary clinical symptoms of joint swelling and pain. Among the currently available therapeutic agents, methotrexate (MTX) is an internationally recognized first-line disease-modifying antirheumatic drug (DMARD) for RA and is widely used as a basic drug in combination therapies. The Bushen Jiedu Tongluo Decoction (BSJDTL), an herbal formula, has been used for the treatment of RA for more than ten years with a better curative effect. Therefore, we designed a multi-center, randomized, double-blind, placebo-controlled study, to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA.
Methods: This was a multi-center, randomized, double-blind placebo-controlled trial. A total of 120 adult participants with active RA will be enrolled, with a balanced treatment allocation (1:1). The treatment intervention will be BSJDTL plus the conventional medicine methotrexate, and the control intervention will be placebo plus the conventional drug methotrexate for 24 weeks. In addition, both groups received folic acid during treatment to prevent side effects of methotrexate. The primary outcome was DAS28-ESR. Secondary outcomes included changes in joint symptoms and signs, ESR, CRP, MIF, MMP2, CD147, ICAM-1, VCAM-1, and HIF-1α levels, and joint evaluation via musculoskeletal ultrasound and X-ray.
Discussion: We designed this multi-center, randomized, double-blind, placebo-controlled clinical trial, utilizing assessment of RA activity and imaging techniques (musculoskeletal ultrasound and X-ray) to scientifically evaluate the clinical efficacy and safety of BSJDTL for active RA. The results of this trial may provide insights into improving the clinical symptoms of patients with RA. We hope that this trial will provide preliminary evidence of the efficacy of BSJDTL in treating RA patients and that these results will aid researchers, practitioners, and patients alike.
Aim: This study aimed to clarify the efficacy and safety of BSJDTL in patients with active RA.
Trial registration: International Traditional Medicine Clinical Trial Registry, ITMCTR2025000194.
期刊介绍：
Journal of Pain Research is an international, peer-reviewed, open access journal that welcomes laboratory and clinical findings in the fields of pain research and the prevention and management of pain. Original research, reviews, symposium reports, hypothesis formation and commentaries are all considered for publication. Additionally, the journal now welcomes the submission of pain-policy-related editorials and commentaries, particularly in regard to ethical, regulatory, forensic, and other legal issues in pain medicine, and to the education of pain practitioners and researchers.
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