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野草成分含有製品“ふし自慢 塗るタイプ”の使用が健常者の膝や肩,腰の違和感に及ぼす影響―ランダム化プラセボ対照二重盲検並行群間比較試験―
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JPY
Abstract
Objective This study aimed to examine the effects of“Fushi-jiman(gel type)”on the knees, shoulders, and/or waist joints in healthy Japanese adult subjects“. Fushi-jiman(gel type)”contains multiple wild plant components, such as glucosamine hydrochloride, sodium chondroitin sulfate, and boswellia serata extract. Methods We conducted a randomized, double-blind, placebo-controlled, parallel-group trial from November 1, 2019 to April 3, 2020. The effects of“Fushi-jiman(gel type)”on the knee joints of 66 healthy Japanese adult subjects was examined. Subjects were randomly assigned to groups in which“Fushi-jiman(gel type)”(Fushi-jiman group)or placebo ointment(P group) (n=33 per group)was applied. Randomization was performed using a computerized random number generator. The“Fushi-jiman(gel type)”or placebo ointment was applied twice per day for four weeks. Changes in the total score for the Japanese Knee Osteoarthritis Measure (JKOM; primary outcome), other parameters of the JKOM, and subjective symptoms regarding the quality of life were assessed. Results Data were analyzed with the intention to treat. Each group consisted of 33 subjects. After four-week of intervention, in JKOM, the total score, the visual analog scale of knee pain, and the scores of“General activities”and“Health conditions”significantly improved in the Fushi-jiman group compared to the P group. No adverse events were observed. Conclusions These results suggest that“Fushi-jiman(gel type)”reduces discomfort in the knee joints of healthy Japanese adults. Trial Registration:UMIN-CTR: UMIN000038450 Foundation:YASOUKOUSO Co., Ltd.
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