Efficacy of Acupuncture-Mesalazine Combination Therapy in Ulcerative Colitis.

Официальное название

Efficacy of Acupuncture Combined With Mesalazine in Inducing and Maintaining Clinical Remission in Mild-to-Moderate Active Ulcerative Colitis: A Single-Center, Randomized Controlled Clinical Trial.

Обзор

This study aims to evaluate the efficacy and safety of acupuncture combined with mesalazine (an integrated acupuncture-medication regimen) for ulcerative colitis.

Подробное описание

1. A randomized controlled trial. 2. Acupuncture treatment(intradermal thumbtack needle embedding), placebo control. 3. To explore the efficacy and safety of acupuncture(intradermal thumbtack needles embedding) as an adjuvant therapy for active ulcerative colitis. 4. To explore the potential relevant mechanisms.

Вмешательства

• Устройство Acupuncture
  Intradermal thumbtack needle embedding at specified acupoints. Needles are embedded for up to 72 hours, replaced weekly for 12 weeks. Patients press needles 3-5 times daily to elicit deqi sensation.
• Устройство Sham acupuncture
  Application of needle-free adhesive placebo patches at non-acupoint sites. Patches are replaced weekly for 12 weeks. Patients apply gentle pressure 3-5 times daily without deqi sensation.
• Препарат Mesalazine
  Standard background therapy: Mesalazine at a stable dose (e.g., 2-4g/day) maintained throughout the 12-week study period. This provides the background treatment for both groups, allowing evaluation of the additive effect of acupuncture.

Первичные конечные точки

• Clinical remission rate [Срок оценки: Week 13-16 after randomization]

Вторичные конечные точки (12)

• Clinical response rate [Срок оценки: Week 13-16 after randomization]
• Endoscopic improvement rate [Срок оценки: Week 13-16 after randomization]
• Endoscopic remission (normalization) rate [Срок оценки: Week 13-16 after randomization]
• Symptomatic remission rate [Срок оценки: Week 12 and 24 after randomization]
• Symptomatic response rate [Срок оценки: Week 12 and 24 after randomization]
• Number of remission-relapse episodes [Срок оценки: Week 24 after randomization]
• Time to first relapse [Срок оценки: Week 24 after randomization]
• Use of rescue medication [Срок оценки: Week 24 after randomization]
• Change in Nancy Histological Index score [Срок оценки: Week 13-16 after randomization]
• Change in fecal calprotectin level [Срок оценки: Baseline, Week 12, Week 24]
• Change in C-reactive protein level [Срок оценки: Baseline, Week 12, Week 24]
• Change in erythrocyte sedimentation rate [Срок оценки: Baseline, Week 12, Week 24]

Критерии участия

Критерии включения

• documented diagnosis of UC；
• age 18-65 years, regardless of gender;
• mildly to moderately active UC, defined as a baseline total Mayo score between 3 and 10；
• willing to receive the complete protocol of intradermal thumbtack needle embedding therapy (12 sessions across three treatment courses)；
• Willing to undergo two colonoscopies (pre-treatment and post-treatment)；
• complete all baseline assessments;
• capable of understanding and voluntarily sign the informed consent form.

Критерии исключения

• diagnosed with or suspected to have other type of inflammatory bowel disease, such as Crohn's disease;
• patients in clinical remission or with severe disease activity ( baseline total Mayo score < 3, or > 10 );
• having severe gastrointestinal complications or a recent surgical history, including but not limited to: short bowel syndrome, toxic megacolon, intestinal perforation, complete intestinal obstruction, active massive gastrointestinal hemorrhage, or having undergone major abdominal or intestinal surgery within the past 6 months.
• patients unwilling to undergo colonoscopy;
• significant or unstable comorbidities (e.g., cardiovascular, respiratory, hepatic, or renal diseases);
• patients with malignant tumors (including but not limited to colorectal cancer);
• patients with a history of intradermal thumbtack needle embedding;
• pregnant or lactating women;
• patients with mental illness;
• patients with either coagulation disorders or skin conditions (such as diseases, infections, ulcers, scars, or tumors at the acupuncture sites) that would preclude acupuncture；
• strong needle phobia or unwillingness to receive acupuncture treatment;
• any other condition (e.g., geographical remoteness, history of poor adherence) that, in the opinion of the investigator, would make the patient unsuitable for the study or likely to be non-compliant with the protocol.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07389824 · UC-ACU(2025TJ01)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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