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Trials. 2019 Feb 19;20(1):140. doi: 10.1186/s13063-019-3234-6.

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.

Author information

1
Chung-Yeon Central Institute, 64, Sangmujungang-ro, Seo-gu, Gwangju, 61949, South Korea.
2
Chung-Yeon Korean Medicine Hospital, 64, Sangmujungang-ro, Seo-gu, Gwangju, 61949, South Korea.
3
Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon, 34520, South Korea.
4
Dongshin Korean Medicine Hospital, 351, Omok-ro, Yangcheon-gu, Seoul, 07999, South Korea.
5
Department of Korean Rehabilitation Medicine, College of Korean Medicine, Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon, 34520, South Korea.
6
Department of Korean Medicine Obstetrics & Gynecology, College of Korean Medicine, Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon, 34520, South Korea.
7
East West Cancer Center, Dunsan Korean Medicine Hospital of Daejeon University, 75, 176 Bun-gil, Daedeok-daero, Seo-gu, Daejeon City, 35235, South Korea.
8
Department of Neuropsychiatry, Dunsan Korean Medicine Hospital of Daejeon University, 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon, 35235, South Korea.
9
Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, 62, Daehak-ro, Dong-gu, Daejeon, 34520, South Korea. judy-orient@hanmail.net.
10
Department of Internal Medicine, Dunsan Korean Medicine Hospital of Daejeon University, 75, Daedeok-daero 176 beon-gil, Seo-gu, Daejeon, 35235, South Korea. omdpyc@dju.kr.

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.

KEYWORDS:

Gui Zhi Jia Shu Fu Tang; Gyejigachulbutang; Keishikajutsubuto; Knee osteoarthritis; Protocol; Randomized controlled trial; TJ-18; Traditional medicine

PMID:
30782208
PMCID:
PMC6381693
DOI:
10.1186/s13063-019-3234-6
[Indexed for MEDLINE]
Free PMC Article

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