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Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.
Official title: Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2024-11-01
Completion Date
2026-10-31
Last Updated
2024-09-27
Healthy Volunteers
No
Conditions
Interventions
Acupuncture
Acupuncture sessions will use sterile, disposable stainless-steel needles (0.3 mm × 40 mm and 0.3 mm × 75 mm). Each session has two phases: Supine Position: * Needles (0.35 mm × 75 mm) are inserted into ST25, ST15, and SP14, reaching the abdominal muscle layer. * Needles (0.30 mm × 40 mm) are inserted into CV12, CV4, ST36, ST37, and SP6. * Electroacupuncture (EA) at ST25, SP15, and ST36 uses a continuous 5 Hz wave, 0.1 to 2.0 mA. Prone Position: * Needles are inserted into BL32, BL33, and BL35 with precise angles and depths. * EA at BL32, BL33, and BL35 uses a continuous 5 Hz wave, 2.0 to 6.5 mA. Sessions occur three times a week for the first 4 weeks, then twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.
Sham acupuncture
Sterile, disposable stainless-steel needles (0.30 mm × 25 mm) will be used. After skin sterilization, needles will be inserted into the same points as the acupuncture group but to a shallow depth of 2 to 3 mm and lightly manipulated for blinding. Paired alligator clips will be attached to the same points, but the sham EA apparatus will have no current output, though it mimics the active EA apparatus in appearance and sound. Sham sessions will follow the same schedule as the acupuncture group: three times a week for the first 4 weeks and twice a week for weeks 5 to 8, each lasting 40 minutes, totaling 20 sessions.