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
Abstract Background Asthma is a chronic disease characterized by airway inflammation and obstruction. 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...
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BMC
2025-02-01
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| Series: | BMC Complementary Medicine and Therapies |
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| Online Access: | https://doi.org/10.1186/s12906-025-04799-w |
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| author | Sung-Woo Kang Hae-Seong Nam Yang-Chun Park Jun-Yong Choi Ki-Tae Kim Seo-Jung Ha Kwan-Il Kim Hee-Jae Jung Beom-Joon Lee |
| author_facet | Sung-Woo Kang Hae-Seong Nam Yang-Chun Park Jun-Yong Choi Ki-Tae Kim Seo-Jung Ha Kwan-Il Kim Hee-Jae Jung Beom-Joon Lee |
| author_sort | Sung-Woo Kang |
| collection | DOAJ |
| description | Abstract Background Asthma is a chronic disease characterized by airway inflammation and obstruction. 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. Methods 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 25–75%, 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. Discussion 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. Trial registration This study was registered in the Clinical Research Information Service of Korea (KCT0006005), on March 16, 2021. |
| format | Article |
| id | doaj-art-c7074639eab344eabb90bfa6b43a7656 |
| institution | DOAJ |
| issn | 2662-7671 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
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| series | BMC Complementary Medicine and Therapies |
| spelling | doaj-art-c7074639eab344eabb90bfa6b43a76562025-08-20T02:48:26ZengBMCBMC Complementary Medicine and Therapies2662-76712025-02-0125111210.1186/s12906-025-04799-wEffect of add-on therapy with leukotriene receptor antagonists and Chungsangboha-tang in patients with asthma: a protocol for a randomized, placebo-controlled, parallel, multicenter trialSung-Woo Kang0Hae-Seong Nam1Yang-Chun Park2Jun-Yong Choi3Ki-Tae Kim4Seo-Jung Ha5Kwan-Il Kim6Hee-Jae Jung7Beom-Joon Lee8Department of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee UniversityDivision of Pulmonology, Department of Internal Medicine, Inha University Hospital, Inha University School of MedicineDepartment of Internal Medicine, College of Korean Medicine, Daejeon UniversityDepartment of Internal Medicine, School of Korean Medicine, Pusan National UniversityDepartment of Korean Medicine, College of Korean Medicine, Semyung UniversityDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji UniversityDepartment of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee UniversityDepartment of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee UniversityDepartment of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee UniversityAbstract Background Asthma is a chronic disease characterized by airway inflammation and obstruction. 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. Methods 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 25–75%, 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. Discussion 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. Trial registration This study was registered in the Clinical Research Information Service of Korea (KCT0006005), on March 16, 2021.https://doi.org/10.1186/s12906-025-04799-wAsthmaChungsangboha-tangHerbal medicineKorea traditional medicineLeukotriene receptor antagonists |
| spellingShingle | Sung-Woo Kang Hae-Seong Nam Yang-Chun Park Jun-Yong Choi Ki-Tae Kim Seo-Jung Ha Kwan-Il Kim Hee-Jae Jung Beom-Joon Lee 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 BMC Complementary Medicine and Therapies Asthma Chungsangboha-tang Herbal medicine Korea traditional medicine Leukotriene receptor antagonists |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Asthma Chungsangboha-tang Herbal medicine Korea traditional medicine Leukotriene receptor antagonists |
| url | https://doi.org/10.1186/s12906-025-04799-w |
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