ISSN: 2167-0870
Kunio Kasugai
Japan
Protocol Article
The Efficacy of the Kampo Formula Keishikashakuyakuto for Irritable Bowel Syndrome: A Phase 3, Multicenter, Double-Blind, Placebo- Controlled, Randomized Controlled Trial
Author(s): Takuma Higurashi, Akiko Fuyuki, Hidenori Ohkubo, Hiroshi Iida, Masahiko Inamori, Masataka Taguri, Yasuhiko Komiya, Shungo Goto, Leo Taniguchi, Naoya Okada, Takafumi Ito, Akira Mizuki, Noriaki Manabe, Ken Haruma, Mitsuo Nagasaka, Yoshihito Nakagawa, Naoki Ohmiya, Sayuri Yamamoto, Yasushi Funaki, Kunio Kasugai and Atsushi NakajimaTakuma Higurashi, Akiko Fuyuki, Hidenori Ohkubo, Hiroshi Iida, Masahiko Inamori, Masataka Taguri, Yasuhiko Komiya, Shungo Goto, Leo Taniguchi, Naoya Okada, Takafumi Ito, Akira Mizuki, Noriaki Manabe, Ken Haruma, Mitsuo Nagasaka, Yoshihito Nakagawa, Naoki Ohmiya, Sayuri Yamamoto, Yasushi Funaki, Kunio Kasugai and Atsushi Nakajima
Background: Irritable bowel syndrome (IBS) is a common gastrointestinal functional disorder characterized by abdominal pain and altered bowel habits in the absence of any structural abnormality. IBS patients often suffer from abdominal symptoms and severe reduction in quality of life (QOL). The Kampo formula keishikashakuyakuto (KST) is considered effective for IBS abdominal pain. However, there are few high-quality randomized controlled trials of Kampo treatment of IBS. Methods: This will be a multicenter, double-blind, placebo-controlled, randomized controlled trial using patients who fulfil the Rome IV criteria for IBS. All eligible patients will be randomly allocated into either a KST group or a placebo group. Patients in the KST group will receive an oral dose of 2.5 g KST three times per day before or between meals for 8 weeks. Patients in the placebo group will receive placebo med.. View More»
DOI:
10.4172/2167-0870.1000345