Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial
Abstract Background Gyejibokryeong-hwan (GBH) is an herbal medicine composed of five herbs. It has been widely used to treat gynaecological diseases in traditional East Asian medicine. Recent animal studies suggest antidepressant effects of GBH. In this trial, we explore the efficacy and safety of G...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2022-06-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06339-0 |
| _version_ | 1818202829013123072 |
|---|---|
| author | Yujin Choi In Chul Jung Ju Yeon Kim Seung-Hun Cho Yunna Kim Sun-Yong Chung Hui-Yong Kwak Doo Suk Lee Wonwoo Lee In-Jeong Nam Changsop Yang Mi Young Lee |
| author_facet | Yujin Choi In Chul Jung Ju Yeon Kim Seung-Hun Cho Yunna Kim Sun-Yong Chung Hui-Yong Kwak Doo Suk Lee Wonwoo Lee In-Jeong Nam Changsop Yang Mi Young Lee |
| author_sort | Yujin Choi |
| collection | DOAJ |
| description | Abstract Background Gyejibokryeong-hwan (GBH) is an herbal medicine composed of five herbs. It has been widely used to treat gynaecological diseases in traditional East Asian medicine. Recent animal studies suggest antidepressant effects of GBH. In this trial, we explore the efficacy and safety of GBH in patients with major depressive disorder and to identify the optimal dose for the next phase III trial. Methods This trial will enrol 126 patients diagnosed with major depressive disorder and not treated with antidepressants. Participants will be randomised to receive a high or a low dose of GBH or placebo granules. The study drugs will be administered three times a day, for 8 weeks. The 17-item Hamilton Depression Rating Scale (HDRS) will be used to measure the severity of depressive symptoms at weeks 2, 4, 6, 8, and 12. The primary efficacy endpoint is the change from baseline in HDRS-17 total score post-treatment at week 8. Analysis of covariance will be based on the baseline HDRS-17 total score and site as the covariates. Safety assessment will be based on the frequency of adverse events. The severity and causality of the study drug will be assessed. Discussion This study is designed to evaluate the efficacy and safety of GBH granules compared with placebo in patients with major depressive disorder. Trial registration Clinical Research Information Service KCT0004417 . Registered on November 1, 2019 (prospective registration) |
| first_indexed | 2024-12-12T03:15:40Z |
| format | Article |
| id | doaj.art-9464056a05804a6b8f9d10963a107f75 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-12T03:15:40Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-9464056a05804a6b8f9d10963a107f752022-12-22T00:40:17ZengBMCTrials1745-62152022-06-0123111210.1186/s13063-022-06339-0Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trialYujin Choi0In Chul Jung1Ju Yeon Kim2Seung-Hun Cho3Yunna Kim4Sun-Yong Chung5Hui-Yong Kwak6Doo Suk Lee7Wonwoo Lee8In-Jeong Nam9Changsop Yang10Mi Young Lee11KM Science Research Division, Korea Institute of Oriental MedicineDepartment of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon UniversityDepartment of Neuropsychiatry, Daejeon Korean Medicine Hospital of Daejeon UniversityDepartment of Neuropsychiatry, College of Korean Medicine, Kyung Hee UniversityDepartment of Neuropsychiatry, College of Korean Medicine, Kyung Hee UniversityDepartment of Neuropsychiatry, College of Korean Medicine, Kyung Hee UniversityDepartment of Neuropsychiatry, College of Korean Medicine, Kyung Hee UniversityR&D Center for Innovative Medicines, Helixmith Co., Ltd.R&D Center for Innovative Medicines, Helixmith Co., Ltd.R&D Center for Innovative Medicines, Helixmith Co., Ltd.KM Science Research Division, Korea Institute of Oriental MedicineKM Convergence Research Division, Korea Institute of Oriental MedicineAbstract Background Gyejibokryeong-hwan (GBH) is an herbal medicine composed of five herbs. It has been widely used to treat gynaecological diseases in traditional East Asian medicine. Recent animal studies suggest antidepressant effects of GBH. In this trial, we explore the efficacy and safety of GBH in patients with major depressive disorder and to identify the optimal dose for the next phase III trial. Methods This trial will enrol 126 patients diagnosed with major depressive disorder and not treated with antidepressants. Participants will be randomised to receive a high or a low dose of GBH or placebo granules. The study drugs will be administered three times a day, for 8 weeks. The 17-item Hamilton Depression Rating Scale (HDRS) will be used to measure the severity of depressive symptoms at weeks 2, 4, 6, 8, and 12. The primary efficacy endpoint is the change from baseline in HDRS-17 total score post-treatment at week 8. Analysis of covariance will be based on the baseline HDRS-17 total score and site as the covariates. Safety assessment will be based on the frequency of adverse events. The severity and causality of the study drug will be assessed. Discussion This study is designed to evaluate the efficacy and safety of GBH granules compared with placebo in patients with major depressive disorder. Trial registration Clinical Research Information Service KCT0004417 . Registered on November 1, 2019 (prospective registration)https://doi.org/10.1186/s13063-022-06339-0Major depressive disorderPhase II studyGyejibokryeong-hwanGuizhifuling-wanKeishibukuryo-GanHerbal medicine |
| spellingShingle | Yujin Choi In Chul Jung Ju Yeon Kim Seung-Hun Cho Yunna Kim Sun-Yong Chung Hui-Yong Kwak Doo Suk Lee Wonwoo Lee In-Jeong Nam Changsop Yang Mi Young Lee Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial Trials Major depressive disorder Phase II study Gyejibokryeong-hwan Guizhifuling-wan Keishibukuryo-Gan Herbal medicine |
| title | Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial |
| title_full | Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial |
| title_fullStr | Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial |
| title_full_unstemmed | Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial |
| title_short | Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial |
| title_sort | efficacy and safety of gyejibokryeong hwan gbh in major depressive disorder study protocol for multicentre randomised controlled trial |
| topic | Major depressive disorder Phase II study Gyejibokryeong-hwan Guizhifuling-wan Keishibukuryo-Gan Herbal medicine |
| url | https://doi.org/10.1186/s13063-022-06339-0 |
| work_keys_str_mv | AT yujinchoi efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT inchuljung efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT juyeonkim efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT seunghuncho efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT yunnakim efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT sunyongchung efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT huiyongkwak efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT doosuklee efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT wonwoolee efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT injeongnam efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT changsopyang efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial AT miyounglee efficacyandsafetyofgyejibokryeonghwangbhinmajordepressivedisorderstudyprotocolformulticentrerandomisedcontrolledtrial |