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The Effect of Shigyakusan Used for IBS and MUPS Diagnosed by Abdominal N Line Tenderness

NCT02653937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2016-01-13

No results posted yet for this study

Summary

Abstract

Background \& Aims:

Abdominal N line tenderness for diagnosis and shigyakusan for treatment of irritable bowel syndrome ( IBS ) and medically unexplained physical symptoms ( MUPS ) were studied.

K1 is point of one quarters of distance from center of navel to right anterior superior iliac spine. K2 is one quarters of distance from center of navel to upside of the symphysis pubis. K3 is center of line from xiphoid process to navel. There are three relevant lines; K1-K3 line, K2-K3 line, and line of identical length to K1-K3 line originating from K2 and running parallel to K1-K3 line. Author collectively named these 'N line'. There was not the study under author's investigation that effects of shigyakusan and other medicines were compared. Author confirmed existence of mild IBS, for whose patients existing largely, various expensive examinations are spent.

Method:

The author put pressure on N line by deep palpitation and judged of abdominal N line tenderness positive or negative.

Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS by Rome III, of no IBS by Rome III, and of MUPS. The change of symptoms of IBS and MUPS by shigyakusan was showed with an arrow by self-declaration.

Conclusions:

Shigyakusan was more effective for IBS than previous medicines. IBS was diagnosed by Rome III and N line tenderness and author confirmed the existence of mild IBS which was diagnosed by N line tenderness with help of RomeIII. MUPS showed N line tenderness though patients complained of no abdominal symptoms. Shigyakusan was very effective for IBS, mild IBS and MUPS.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Tsumura's shigyakusan

Shigyakusan appears in the early 3rd Century. Four herbal crude medicines included are the following: Root of Bupleurum falcatum L Unripe fruit of Citrus aurantium Linne var. daidai Makino, Citrus aurantium Linne, or Citrus natsu-daidai Hayata (Rutaceae) Root of Paeonia lactiflora Pall Root and stolon of Glycyrrhiza uralensis Fisher or Glycyrrhiza glabra Linne

Sponsors & Collaborators

  • Wakayama Medical University

    collaborator OTHER

  • Nakatani Clinic

    lead OTHER

Principal Investigators

  • Masaki Nakatani, M.D. Ph.D. · Department of Gastroenterology, School of Medicine, Wakayama Medical Universiyy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-02-28
Completion
2015-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653937 on ClinicalTrials.gov