Irritable Bowel SyndromeNCT02653937
The Effect of Shigyakusan Used for IBS and MUPS Diagnosed by Abdominal N Line Tenderness
A study testing Tsumura's shigyakusan in people with Irritable Bowel Syndrome, run by Nakatani Clinic.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Tsumura's shigyakusan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- good constitution for shigyakusan
Who cannot join
- weak constitution for shigyakusan
About this study
Official title: The Effect of Shigyakusan Used for Irritable Bowel Syndrome and Medically Unexplained Physical Symptoms Diagnosed by Abdominal N Line Tenderness
Abstract
Background \& Aims:
Read more
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.
Read the detailed description
Background \& Aims
The common cause of both IBS and MUPS is generally considered to be mental stress.
The late prof. Masaharu Katsumi at the Wakayama Medical University found two tender points "K1" and "K2" for IBS forty seven years ago. The author found another tender point "K3''. K1 is one quarters of the distance from the center of the navel to the right anterior superior iliac spine. K2 is one quarters of the distance from the center of the navel to the upside of the symphysis pubis. K3 is the center of the line from the xiphoid process to the navel. There are three relevant lines; the K1-K3 line, the K2-K3 line, and the line of identical length to the K1-K3 line originating from K2 and running parallel to the K1-K3 line. The author named these lines "N line" collectively.
The author considers as follows. K1 is the concentration point of nerves coming from the right colon, while K2 is the concentration point of nerves coming from the left colon, i.e. inferior mesenteric plexus. K3 corresponds to the superior mesenteric ganglion. The K1-K3 line corresponds to the root of mesentery. The K2-K3 line corresponds to the abdominal aortic plexus. The line originating from K2 and running parallel to the K1-K3 line is the line that transverses a number of nerves originating from jejunum or ileum, entering side by side into the root of mesentery and running to the superior mesenteric ganglion.
IBS is now diagnosed by the diagnostic criteria formed by symptoms. However, the author considers that medical sign of N line tenderness makes reliable diagnosis.
There was not the study under author's investigation that effects of shigyakusan and other medicines were compared. The author confirmed the existence of mild IBS which was diagnosed by N line tenderness with the help of Rome III, for whose patients existing largely, various expensive examinations and many hours are spent. MUPS showed N line tenderness though the patients complain of no abdominal symptoms.
Method
The author put pressure on the N line slowly by deep palpitation to check for tenderness of the region, comparing N line to the tenderness of the other parts of abdomen. He judged of abdominal N line tenderness positive or negative.
Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS diagnosed by Rome III, of no IBS by Rome III, and of MUPS who have not abdominal symptoms of IBS in this study. The author enrolled 110 out-patients who were treated by shigyakusan at the Corporate Nakatani Clinic for two years from March 2013 to February 2015.
The author thinks that double blind study is the best way that shigyakusan is prescribed to placebo for clear endpoint discovered though it is very difficult to the psychiatric disorder as IBS. However, this time the author assessed the self-declaration of the symptom's change. The change of the symptom was showed with an arrow by self-declaration. An entry format was adopted by showing Table 1 to the patients. For example, ③→① shows the change of symptoms from ③ Significantly bad to ① Almost no symptoms in Table 1. The author used shigyakusan regardless of diarrhea or constipation.
Study of shigyakusan used for IBS:
The author tried to compare previous drugs to shigyakusan. 7.5g per day of Tsumura's shigyakusan ( Tsumura \& Co ) was administered to each of 30 cases of IBS to whom Trimebutine maleate, Polycarbophil calcium and Oxapium iodide had been described, and was administered to each of 18 cases of new patients of IBS and 21 cases of existing patients first treated as IBS.(Table2) These patients were diagnosed as IBS by Rome III and abdominal N line tenderness, undermentioned in 'Regarding abdominal tenderness of N line' (Table 6).
Study of shigyakusan used for mild IBS
The patients of no IBS by Rome III and of abdominal N line tenderness positive were diagnosed as mild IBS for the reason in 'Regarding abdominal tenderness of N line' undermentioned (Table 6).
Shigyakusan was used for each of the patients with IBS who have mild to severe gastrointestinal symptoms without or with only few other bodily complaints or psychobehavioral features[26] :
7.5g per day of Tsumura' shigyakusan was administered to each of 14 cases of mild IBS(Table 3).
Study of shigyakusan used for MUPS:
MUPS are patients' unexplained \& uncertain physical symptoms which are difficult for doctors to find the medical causes though MUPS do not imply that physical causes do not exist. However, MUPS in this study are physical symptoms other than IBS. When shigyakusan was effective for a patient suffered from both physical symptoms of MUPS and abdominal symptoms of IBS, the author adopted IBS.
7.5g per day of Tsumura' shigyakusan was administered to each of 27 MUPS patients who had doubt of psychiatric morbidity, for whom the author found no medical scientific cause(Table4).
Concerning N line when the cause of symptoms was clear
The possibility that the patients are diagnosed as MUPS becomes high if the patients have physical symptoms and show abdominal N line tenderness. When the cause of symptoms was clear without unaccountable or unexplained symptoms by having been examining, the author put pressure on N line by deep palpitation, and the author enumerated the thirty patients' conditions or diseases causing symptoms ( Table5 ).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Tsumura's shigyakusan
- Keywords
- IBS, MUPS, FSS, shigyakusan, Katsumi's points, Nakatani's N line
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tsumura's shigyakusanDrug
Also called There is no other name other than 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
| Study group | Role | What they receive |
|---|---|---|
| Kampo medicine | Experimental | 7.5g per day of Tsumura's shigyakusan ( Tsumura \& Co ) was administered to each of 110 cases. Receives: Drug: Tsumura's shigyakusan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who were suffered from IBS or MUPS, prescribed shigyakusan and improved.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nakatani Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Wakayama Medical University
- Responsible party
- Principal investigator, Masaki Nakatani, MD, Nakatani Clinic
- Investigators
- Masaki Nakatani, M.D. Ph.D., Principal investigator, Department of Gastroenterology, School of Medicine, Wakayama Medical Universiyy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653937
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2016
- First submitted
- 19 Jun 2015
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24876725Riedl 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.
PubMed 18501257
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shigyakusan Used for Irritable Bowel Syndrome and Medically Unexplained Physical Symptoms Diagnosed by Abdominal N Line Tenderness
- ClinicalTrials.gov ID
- NCT02653937
- Acronym / sponsor ID
- 001
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, MUPS, FSS, shigyakusan, Katsumi's points, Nakatani's N line
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nakatani ClinicUniversity, hospital or other
- Collaborators
- Wakayama Medical University
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background \& Aims
The common cause of both IBS and MUPS is generally considered to be mental stress.
The late prof. Masaharu Katsumi at the Wakayama Medical University found two tender points "K1" and "K2" for IBS forty seven years ago. The author found another tender point "K3''. K1 is one quarters of the distance from the center of the navel to the right anterior superior iliac spine. K2 is one quarters of the distance from the center of the navel to the upside of the symphysis pubis. K3 is the center of the line from the xiphoid process to the navel. There are three relevant lines; the K1-K3 line, the K2-K3 line, and the line of identical length to the K1-K3 line originating from K2 and running parallel to the K1-K3 line. The author named these lines "N line" collectively.
The author considers as follows. K1 is the concentration point of nerves coming from the right colon, while K2 is the concentration point of nerves coming from the left colon, i.e. inferior mesenteric plexus. K3 corresponds to the superior mesenteric ganglion. The K1-K3 line corresponds to the root of mesentery. The K2-K3 line corresponds to the abdominal aortic plexus. The line originating from K2 and running parallel to the K1-K3 line is the line that transverses a number of nerves originating from jejunum or ileum, entering side by side into the root of mesentery and running to the superior mesenteric ganglion.
IBS is now diagnosed by the diagnostic criteria formed by symptoms. However, the author considers that medical sign of N line tenderness makes reliable diagnosis.
There was not the study under author's investigation that effects of shigyakusan and other medicines were compared. The author confirmed the existence of mild IBS which was diagnosed by N line tenderness with the help of Rome III, for whose patients existing largely, various expensive examinations and many hours are spent. MUPS showed N line tenderness though the patients complain of no abdominal symptoms.
Method
The author put pressure on the N line slowly by deep palpitation to check for tenderness of the region, comparing N line to the tenderness of the other parts of abdomen. He judged of abdominal N line tenderness positive or negative.
Shigyakusan, a Kampo medicine, was administered to each of N line positive patients, of IBS diagnosed by Rome III, of no IBS by Rome III, and of MUPS who have not abdominal symptoms of IBS in this study. The author enrolled 110 out-patients who were treated by shigyakusan at the Corporate Nakatani Clinic for two years from March 2013 to February 2015.
The author thinks that double blind study is the best way that shigyakusan is prescribed to placebo for clear endpoint discovered though it is very difficult to the psychiatric disorder as IBS. However, this time the author assessed the self-declaration of the symptom's change. The change of the symptom was showed with an arrow by self-declaration. An entry format was adopted by showing Table 1 to the patients. For example, ③→① shows the change of symptoms from ③ Significantly bad to ① Almost no symptoms in Table 1. The author used shigyakusan regardless of diarrhea or constipation.
Study of shigyakusan used for IBS:
The author tried to compare previous drugs to shigyakusan. 7.5g per day of Tsumura's shigyakusan ( Tsumura \& Co ) was administered to each of 30 cases of IBS to whom Trimebutine maleate, Polycarbophil calcium and Oxapium iodide had been described, and was administered to each of 18 cases of new patients of IBS and 21 cases of existing patients first treated as IBS.(Table2) These patients were diagnosed as IBS by Rome III and abdominal N line tenderness, undermentioned in 'Regarding abdominal tenderness of N line' (Table 6).
Study of shigyakusan used for mild IBS
The patients of no IBS by Rome III and of abdominal N line tenderness positive were diagnosed as mild IBS for the reason in 'Regarding abdominal tenderness of N line' undermentioned (Table 6).
Shigyakusan was used for each of the patients with IBS who have mild to severe gastrointestinal symptoms without or with only few other bodily complaints or psychobehavioral features[26] :
7.5g per day of Tsumura' shigyakusan was administered to each of 14 cases of mild IBS(Table 3).
Study of shigyakusan used for MUPS:
MUPS are patients' unexplained \& uncertain physical symptoms which are difficult for doctors to find the medical causes though MUPS do not imply that physical causes do not exist. However, MUPS in this study are physical symptoms other than IBS. When shigyakusan was effective for a patient suffered from both physical symptoms of MUPS and abdominal symptoms of IBS, the author adopted IBS.
7.5g per day of Tsumura' shigyakusan was administered to each of 27 MUPS patients who had doubt of psychiatric morbidity, for whom the author found no medical scientific cause(Table4).
Concerning N line when the cause of symptoms was clear
The possibility that the patients are diagnosed as MUPS becomes high if the patients have physical symptoms and show abdominal N line tenderness. When the cause of symptoms was clear without unaccountable or unexplained symptoms by having been examining, the author put pressure on N line by deep palpitation, and the author enumerated the thirty patients' conditions or diseases causing symptoms ( Table5 ).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kampo medicine | Experimental | Drug: Tsumura's shigyakusan7.5g per day of Tsumura's shigyakusan ( Tsumura \& Co ) was administered to each of 110 cases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- good constitution for shigyakusan
Key exclusion criteria (1 listed)
- weak constitution for shigyakusan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tsumura's shigyakusanAlso: There is no other name other than 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 | Drug | Kampo medicine |
Primary outcome
Number of participants who were suffered from IBS or MUPS, prescribed shigyakusan and improved.
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Results publication: PubMed 24876725Hausteiner-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.
- Results publication: PubMed 18501257Riedl 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 20233451Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaki Nakatani, M.D. Ph.D. principal investigator
Department of Gastroenterology, School of Medicine, Wakayama Medical Universiyy
Questions about this trial
What is this clinical trial studying?
A study testing Tsumura's shigyakusan in people with Irritable Bowel Syndrome, run by Nakatani Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who were suffered from IBS or MUPS, prescribed shigyakusan and improved. (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653937, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2016.