Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615765
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-22
Brief Title:
Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ulcerative colitis UC is one of the two primary forms of inflammatory bowel disease This condition is characterized by continuous mucosal inflammation that begins in the rectum and extends proximally throughout the colon Common intestinal symptoms also include rectal bleeding increased stool frequency tenesmus nocturnal bowel movements and crampy abdominal pain Acupuncture has been suggested as a potential intervention to alleviate clinical symptoms of UC This single-center parallel-group two-arm randomized sham-controlled trial aims to evaluate the effects and safety of acupuncture for UC
Detailed Description:
Ulcerative colitis UC is a chronic inflammatory bowel disease characterized by episodes of symptoms including rectal bleeding increase stool frequency and abdominal pain impacting quality of life significantly Conventional treatments often come with potential side effects and may not be sufficient Acupuncture is increasingly recognized for its promising benefits in UC This study aims to assess the efficacy and safety of acupuncture for symptom relief in mild to moderate UCThis single-center parallel-arm randomized sham-controlled trial will involve 64 patients with UC randomly assigned in a 11 ratio to either the acupuncture or sham acupuncture group Participants will receive 20 sessions of acupuncture or sham acupuncture over eight weeks Blinding will be applied to participants outcome assessors and statisticians The primary outcome measure is the change in Patient-Reported Outcome 2 PRO2 from baseline at week 8 Secondary outcomes include changes from baseline in the following scales PRO2 at other time points weekly average Numeric Rating Scale U-NRS for bowel urgency weekly average NRS for abdominal pain both associated and not associated with bowel movement the 32-item Inflammatory Bowel Disease Questionnaire IBDQ-32 Work Productivity and Activity Impairment Questionnaire-Inflammatory Bowel Disease WPAI-IBD Pittsburgh Sleep Quality Index PSQI and Hospital Anxiety and Depression Scale HADS Patient Global Impression of Change PGIC will also be assessed as secondary outcomes Adverse events and additional treatments will be monitored throughout the study The modified intention-to-treat mITT population will include participants who complete baseline assessments and receive at least one treatment session
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None