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Treatment aims to control symptoms with minimal medication, using disease-controlling and symptom-relieving drugs. Inhaled steroids and beta2 agonists are common treatments; however, their long-term use can cause side effects. Leukotriene receptor antagonists (LTRAs) are used in combination with inhaled steroids to manage asthma because of their anti-inflammatory and bronchodilatory effects. Combining LTRAs with Chungsangboha-tang (CSBHT), a Korean medicine, may enhance their efficacy. This study aimed to evaluate the potential of CSBHT as an adjunctive therapy for asthma management in a randomized, placebo-controlled, double-blind, multicenter clinical trial.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>This randomized, placebo-controlled, double-blind, parallel-group, multicenter study aims to evaluate the efficacy and safety of CSBHT as an additional treatment for patients with asthma, particularly for those with LTRAs. Overall, 198 participants will be randomly divided into intervention and control groups, with the former receiving CSBHT thrice daily and the latter receiving a placebo. Follow-ups at weeks 0, 4, and 8 will include outcome measurements, medication dispensation, and adverse reaction monitoring. The primary outcome is the mean change in forced expiratory volume in one-second scores, with secondary outcomes including changes in peak expiratory flow, forced vital capacity, forced expiratory flow 25\u201375%, fractional exhaled nitric oxide, Asthma Control Test, Asthma Quality of Life Questionnaire, serum IgE, eosinophil count, C-reactive protein, rescue medication usage, and a descriptive analysis of the questionnaire on asthma symptoms in Korean medicine. Safety assessments will be conducted using laboratory tests, vital signs, and monitoring of adverse events. Economic evaluations will be conducted using either cost-minimization analysis or cost-utility analysis.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Discussion<\/jats:title>\n            <jats:p>This trial will evaluate the efficacy, safety, and cost-effectiveness of CSBHT as an add-on therapy to LTRAs to establish its potential as an adjuvant therapy in asthma management.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>This study was registered in the Clinical Research Information Service of Korea (KCT0006005), on March 16, 2021.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/s12906-025-04799-w","type":"journal-article","created":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T16:37:28Z","timestamp":1739551048000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Effect of add-on therapy with leukotriene receptor antagonists and Chungsangboha-tang in patients with asthma: a protocol for a randomized, placebo-controlled, parallel, multicenter trial"],"prefix":"10.1186","volume":"25","author":[{"given":"Sung-Woo","family":"Kang","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hae-Seong","family":"Nam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yang-Chun","family":"Park","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun-Yong","family":"Choi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ki-Tae","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seo-Jung","family":"Ha","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwan-Il","family":"Kim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hee-Jae","family":"Jung","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beom-Joon","family":"Lee","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2025,2,14]]},"reference":[{"issue":"10122","key":"4799_CR1","doi-asserted-by":"publisher","first-page":"783","DOI":"10.1016\/S0140-6736(17)33311-1","volume":"391","author":"A Papi","year":"2018","unstructured":"Papi A, Brightling C, Pedersen SE, Reddel HK. 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Any changes to a previously approved protocol require IRB approval. This study was conducted in accordance with the principles of the Declaration of Helsinki, and all patients provided informed consent prior to enrollment. The principal investigator or sub-investigators, who are doctors or Korean medicine doctors delegated by the principal investigator, will conduct face-to face interview with each subject to explain all aspects of the study, including its purpose, methodology, potential side effects, and safety protocols. Subjects will be afforded sufficient time and opportunity to ask questions about the study and to decide whether to participate voluntarily. Written consent for study participation will be obtained from the principal investigator or sub-investigators. Informational materials for participants aged 65 and older will be provided in larger print and explained slowly. Hospital staff will be regarded as vulnerable subjects and will be requested to provide handwritten consent on the informed consent form. The results of this clinical trial will be shared publicly at academic conferences and in peer-reviewed journals.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"54"}}