Clinical Trial: Effects of Contact Acupuncture on Women with Constipation Symptoms: An Exploratory Evaluation of Tongue Appearance, Skin Findings, Autonomic Nervous System Function, and Gut Microbiota (Japan)

Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063424) titled 'Effects of Contact Acupuncture on Women with Constipation Symptoms: An Exploratory Evaluation of Tongue Appearance, Skin Findings, Autonomic Nervous System Function, and Gut Microbiota' on Nov. 1.

Study Type: Observational

Primary Sponsor: Institute - Other

Condition: Condition - Constipation Symptoms Classification by malignancy - Others Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 30 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 Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2006 Year 12 Month 15 Day Anticipated trial start date - 2027 Year 02 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072592

Disclaimer: Curated by HT Syndication.