Dataset Information

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

ABSTRACT:

Background

This study aims to assess the efficacy and safety of geonchildan, a Korean traditional herbal medicine, for patients with active rheumatoid arthritis (RA) and evaluate the feasibility of a large-scale confirmatory clinical trial.

Methods/design

This is a randomized, double-blind, placebo-controlled, parallel two-arm pilot trial in Seoul, Korea. Altogether, 30 patients diagnosed with RA for at least 3 months and with a Disease Activity Score for 28 joints (DAS28)???3.2 will be enrolled. Participants are randomly assigned to one of two groups, the experimental group or the placebo group, in a 1:1 ratio and will make four scheduled visits. The participants will be administered geonchildan or a placebo three times per day for 12 weeks. The change in DAS28 will be examined as the primary efficacy outcome. The secondary efficacy outcomes include the proportion of patients achieving ACR20, ACR50, ACR70, and EULAR responses; the DAS28 sub-items; the consumption of medication; Korean Health Assessment Questionnaire scores; inflammatory parameters; and the Korean medical diagnostic pattern indicator. Adverse events and laboratory test results will be recorded to evaluate safety. The process, resources used, and management of the study will also be assessed to determine the feasibility of a large-scale trial.

Discussion

This is the first clinical trial to explore the efficacy and safety of geonchildan in patients with active RA. If the superiority of geonchildan versus the placebo is demonstrated and the study design is feasible, this study could form the foundation for a large-scale clinical trial. The results will be published in a peer-reviewed journal.

Trial registration

Clinical Research Information Service, KCT0001943 . Registered on 14 June 2016.

SUBMITTER: Lee S

PROVIDER: S-EPMC6122614 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Publications

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

Lee Seunghoon S Cho Yeeun Y Kim Jihye J Kang Jung Won JW Yoon Ga Young GY Lee Jun-Hwan JH Jung So-Young SY Kwon Ojin O Shin Kyung-Min KM Lee Jae-Dong JD

Trials 20180903 1

<h4>Background</h4>This study aims to assess the efficacy and safety of geonchildan, a Korean traditional herbal medicine, for patients with active rheumatoid arthritis (RA) and evaluate the feasibility of a large-scale confirmatory clinical trial.<h4>Methods/design</h4>This is a randomized, double-blind, placebo-controlled, parallel two-arm pilot trial in Seoul, Korea. Altogether, 30 patients diagnosed with RA for at least 3 months and with a Disease Activity Score for 28 joints (DAS28) ≥ 3.2 w ...[more]

PMID: 30176923

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Dataset Information

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

Background

Methods/design

Discussion

Trial registration

Publications

The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial.

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