UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063424 |
|---|---|
| Receipt number | R000072592 |
| Scientific Title | Effects of Contact Acupuncture on Women with Constipation Symptoms: An Exploratory Evaluation of Tongue Appearance, Skin Findings, Autonomic Nervous System Function, and Gut Microbiota |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/29 11:49:27 |
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Basic information
Public title
Effects of Contact Acupuncture on Women with Constipation Symptoms: An Exploratory Evaluation of Tongue Appearance, Skin Findings, Autonomic Nervous System Function, and Gut Microbiota
Acronym
An Observational Study of Contact Acupuncture in Women with Constipation Symptoms
Scientific Title
Effects of Contact Acupuncture on Women with Constipation Symptoms: An Exploratory Evaluation of Tongue Appearance, Skin Findings, Autonomic Nervous System Function, and Gut Microbiota
Scientific Title:Acronym
An Exploratory Observational Study of Contact Acupuncture in Women with Constipation Symptoms
Region
| Japan |
Condition
Condition
Constipation Symptoms
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to longitudinally evaluate constipation symptoms, tongue findings, facial skin findings, autonomic nervous system function, gut microbiota, and gut microbiota-derived metabolites before and after contact acupuncture treatment provided as part of routine clinical care in 20 adult women with constipation symptoms. By comparing changes in these parameters, the study will explore the relationships between changes in constipation symptoms and the various evaluation parameters, and obtain preliminary evidence to investigate the potential usefulness of tongue and skin findings in assessing the pathophysiology of constipation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Constipation Scoring System
Key secondary outcomes
Background information, including age, height, weight, medical history, medication use, lifestyle, and bowel habits, collected using a background questionnaire.
Findings from the four diagnostic methods of Kampo medicine: inspection, listening and smelling, inquiry, and palpation, obtained from medical records.
Gut microbiota analysis using stool samples.
Tongue features, including tongue color and tongue coating, analyzed from tongue photographs.
Facial features, including skin texture, melanin levels, and hemoglobin levels, analyzed from facial photographs.
Tongue features, including texture and shape, analyzed from tongue images.
Skin features, including wrinkles and pores, analyzed from skin images.
Respiratory rate, heart rate, and high-frequency (HF) and low-frequency (LF) components of heart rate variability, measured using an industrial camera.
Assessment of constipation-related quality of life using the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL).
Assessment of bowel movement frequency, stool characteristics, and bowel movement-related symptoms using a daily bowel diary throughout the study perio
Assessment of anxiety and stress-related states using the State-Trait Anxiety Inventory (STAI).
Occurrence of adverse events.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1.Adult women aged 30-60 years.
2.Individuals who perceive themselves as having constipation and have three or fewer bowel movements per week, or symptoms such as difficulty with defecation, hard stools, or a sensation of incomplete evacuation.
3.Individuals who agree to tongue photography, skin photography, autonomic nervous system measurements, stool sample collection, and questionnaire surveys.
4.Individuals who have received an explanation of the study and provided written informed consent.
Key exclusion criteria
1.Individuals with gastrointestinal diseases that may cause organic constipation, such as inflammatory bowel disease, colorectal cancer, or intestinal obstruction.
2.Individuals with severe cardiovascular, liver, kidney, or neurological diseases.
3.Individuals who are pregnant or may be pregnant.
4.Individuals who have used antibiotics within the past three months.
5.Individuals who are scheduled to initiate or change the dosage or type of medications known to affect the gut microbiota during the study period, including antibiotics, gastric acid suppressants (proton pump inhibitors [PPIs] and potassium-competitive acid blockers [P-CABs]), probiotics and other intestinal regulators, laxatives, antidiabetic medications, antithrombotic agents, cardiovascular medications, medications for psychiatric or neurological disorders, anticancer agents, nonsteroidal anti-inflammatory drugs (NSAIDs), and Kampo medicines.
6.Individuals who are otherwise considered unsuitable for participation by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Ogawa |
Organization
Hiroshima University
Division name
Hospital Kampo Medical Center
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
082-257-1921
okeiko22@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hoya |
| Middle name | |
| Last name | Lee |
Organization
Hiroshima University
Division name
Hospital Kampo Medical Center
Zip code
734-0037
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL
08225271921
Homepage URL
hoyalee@hiroshima-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital Ethics Committee
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
Tel
08225275555
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2006 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2027 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072592
