Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial
Abstract Background Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surger...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2019-02-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3234-6 |
| _version_ | 1811204319716835328 |
|---|---|
| author | Jae-Uk Sul Myung Kwan Kim Jungtae Leem Hee-Geun Jo Sang-hoon Yoon Jeeyong Kim Eun-Jung Lee Jeong-Eun Yoo So Jung Park Young Il Kim Eunseok Kim In Chul Jung Ju-Hyun Jeon Yang-Chun Park |
| author_facet | Jae-Uk Sul Myung Kwan Kim Jungtae Leem Hee-Geun Jo Sang-hoon Yoon Jeeyong Kim Eun-Jung Lee Jeong-Eun Yoo So Jung Park Young Il Kim Eunseok Kim In Chul Jung Ju-Hyun Jeon Yang-Chun Park |
| author_sort | Jae-Uk Sul |
| collection | DOAJ |
| description | Abstract Background Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. Methods This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. Discussion This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. Trial registration Clinical Research Information Service (CRIS), KCT0003024. Registered on 25 July 2018. |
| first_indexed | 2024-04-12T03:11:03Z |
| format | Article |
| id | doaj.art-8bf7b71728a0406a86ec675d50880604 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T03:11:03Z |
| publishDate | 2019-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-8bf7b71728a0406a86ec675d508806042022-12-22T03:50:22ZengBMCTrials1745-62152019-02-012011910.1186/s13063-019-3234-6Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trialJae-Uk Sul0Myung Kwan Kim1Jungtae Leem2Hee-Geun Jo3Sang-hoon Yoon4Jeeyong Kim5Eun-Jung Lee6Jeong-Eun Yoo7So Jung Park8Young Il Kim9Eunseok Kim10In Chul Jung11Ju-Hyun Jeon12Yang-Chun Park13Chung-Yeon Central InstituteDepartment of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon UniversityChung-Yeon Central InstituteChung-Yeon Central InstituteChung-Yeon Central InstituteChung-Yeon Central InstituteDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Daejeon UniversityDepartment of Korean Medicine Obstetrics & Gynecology, College of Korean Medicine, Daejeon UniversityEast West Cancer Center, Dunsan Korean Medicine Hospital of Daejeon UniversityDepartment of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon UniversityDepartment of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon UniversityDepartment of Neuropsychiatry, Dunsan Korean Medicine Hospital of Daejeon UniversityDepartment of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon UniversityDepartment of Internal Medicine, Dunsan Korean Medicine Hospital of Daejeon UniversityAbstract Background Degenerative knee osteoarthritis is a leading cause of disability in the elderly. If patients do not respond to pharmacological or nonpharmacological intervention, total knee replacement surgery is recommended. However, owing to the contraindications and adverse effects of surgery, the need for a new treatment strategy is emerging. Traditional herbal medicine is a widely used intervention in east Asia to treat knee osteoarthritis. Gyejigachulbutang is one of the frequently prescribed herbal formulae. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. Methods This study is a randomized, placebo-controlled, patient and assessor blinded, superiority clinical trial. A total of 80 patients with knee osteoarthritis will be enrolled. The participants will be randomly assigned to the gyejigachulbutang or placebo group in a 1:1 ratio in two Korean medical hospitals. Every participant will take gyejigachulbutang or placebo at a dose of 2.5 g three times a day for 4 weeks. Additional follow-up will be conducted 4 weeks after treatment completion. Any concomitant treatment to relive knee pain will not be allowed except for rescue medicine (acetaminophen). The primary outcome will be a comparison of the change in the visual analogue scale score for knee pain from baseline to visit 3 (week 4) for both the treatment and placebo groups. Secondary outcomes include clinical relevance, minimal clinically important difference, disability, quality of life, and safety. Discussion This protocol presents a research methodology for clinical trials of gyejigachulbutang for knee osteoarthritis. Various secondary outcomes make this trial more informative. Our trial will provide fundamental evidence for knee osteoarthritis management via herbal medicine treatment. Trial registration Clinical Research Information Service (CRIS), KCT0003024. Registered on 25 July 2018.http://link.springer.com/article/10.1186/s13063-019-3234-6Knee osteoarthritisGyejigachulbutangGui Zhi Jia Shu Fu TangTJ-18KeishikajutsubutoRandomized controlled trial |
| spellingShingle | Jae-Uk Sul Myung Kwan Kim Jungtae Leem Hee-Geun Jo Sang-hoon Yoon Jeeyong Kim Eun-Jung Lee Jeong-Eun Yoo So Jung Park Young Il Kim Eunseok Kim In Chul Jung Ju-Hyun Jeon Yang-Chun Park Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial Trials Knee osteoarthritis Gyejigachulbutang Gui Zhi Jia Shu Fu Tang TJ-18 Keishikajutsubuto Randomized controlled trial |
| title | Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial |
| title_full | Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial |
| title_fullStr | Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial |
| title_full_unstemmed | Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial |
| title_short | Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial |
| title_sort | efficacy and safety of gyejigachulbutang gui zhi jia shu fu tang keishikajutsubuto tj 18 for knee pain in patients with degenerative knee osteoarthritis a randomized placebo controlled patient and assessor blinded clinical trial |
| topic | Knee osteoarthritis Gyejigachulbutang Gui Zhi Jia Shu Fu Tang TJ-18 Keishikajutsubuto Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-019-3234-6 |
| work_keys_str_mv | AT jaeuksul efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT myungkwankim efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT jungtaeleem efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT heegeunjo efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT sanghoonyoon efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT jeeyongkim efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT eunjunglee efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT jeongeunyoo efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT sojungpark efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT youngilkim efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT eunseokkim efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT inchuljung efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT juhyunjeon efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial AT yangchunpark efficacyandsafetyofgyejigachulbutangguizhijiashufutangkeishikajutsubutotj18forkneepaininpatientswithdegenerativekneeosteoarthritisarandomizedplacebocontrolledpatientandassessorblindedclinicaltrial |