NCT02653937

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
Last Updated

January 13, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

June 19, 2015

Last Update Submit

January 10, 2016

Conditions

Irritable Bowel Syndrome

Keywords

IBSMUPSFSSshigyakusanKatsumi's pointsNakatani's N line

Outcome Measures

Primary Outcomes (1)

  • Number of participants who were suffered from IBS or MUPS, prescribed shigyakusan and improved.

    two years

Study Arms (1)

Kampo medicine

EXPERIMENTAL

7.5g per day of Tsumura's shigyakusan ( Tsumura \& Co ) was administered to each of 110 cases.

Drug: Tsumura's shigyakusan

Interventions

Tsumura's shigyakusanDRUG

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

Also known as: There is no other name other than Tsumura's shigyakusan.
Kampo medicine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • good constitution for shigyakusan

You may not qualify if:

  • weak constitution for shigyakusan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Hausteiner-Wiehle C, Henningsen P. Irritable bowel syndrome: relations with functional, mental, and somatoform disorders. World J Gastroenterol. 2014 May 28;20(20):6024-30. doi: 10.3748/wjg.v20.i20.6024.

    PMID: 24876725RESULT

  • Riedl A, Schmidtmann M, Stengel A, Goebel M, Wisser AS, Klapp BF, Monnikes H. Somatic comorbidities of irritable bowel syndrome: a systematic analysis. J Psychosom Res. 2008 Jun;64(6):573-82. doi: 10.1016/j.jpsychores.2008.02.021. Epub 2008 Apr 28.

    PMID: 18501257RESULT

Related Links

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Masaki Nakatani, M.D. Ph.D.

    Department of Gastroenterology, School of Medicine, Wakayama Medical Universiyy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Researcher in Wakayama Medical University

Study Record Dates

First Submitted

June 19, 2015

First Posted

January 13, 2016

Study Start

March 1, 2013

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

January 13, 2016

Record last verified: 2016-01