Abstract
BackgroundDegenerative 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.MethodsThis 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.DiscussionThis 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 registrationClinical Research Information Service (CRIS), KCT0003024. Registered on 25 July 2018.
Highlights
Degenerative knee osteoarthritis is a leading cause of disability in the elderly
The purpose of this study is to evaluate the efficacy and safety of GCB for degenerative knee osteoarthritis (KOA)
The PP set is defined as follows: 1) compliance of medication consumption is over 70%; 2) every outcome was evaluated; and 3) the patient completed the clinical trial without major protocol violation
Summary
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. The aim of our study is to evaluate the efficacy and safety of gyejigachulbutang for knee osteoarthritis. Diagnosis of degenerative KOA is based on clinical judgment including past history, physical examination, radiology, and laboratory evaluation. In this process, specific causes such as rheumatoid arthritis, gout, and soft tissue damage should be excluded [3]. KOA is a major cause of disability for older patients because progressive loss of articular cartilage leads to joint pain and disability. The quality of life of KOA patients was below the 25th percentile compared with the normative value for healthy people [5]
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