Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Not applicable · Testing Acupuncture · Sites not listed yet · Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Acupuncture as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- Eligible participants are those aged 18 to 70 years who meet the diagnostic criteria for mild to moderate UC, have a PRO2 score of ≥ 2 points, and provide written informed consent. Patients currently receiving oral and/or topical…
There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 64 participants are expected to take part.
- Start date: 2024-11-01 (planned).
- Main results expected around 2026-06-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- change from baseline in the PRO2 score (Week 8 after randomization)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| Enrollment | 64 (estimated) |
| Start date | 2024-11-01 |
| Primary completion (est.) | 2026-06-30 |
| First posted | 2024-09-27 |
| Last updated | 2024-09-27 |
| Official title | Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06615765 |
Interventions
- Acupuncture (Other)
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 c… - Sham acupuncture (Other)
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 apparat…
Full eligibility criteria (from the record)
Inclusion Criteria: Eligible participants are those aged 18 to 70 years who meet the diagnostic criteria for mild to moderate UC, have a PRO2 score of ≥ 2 points, and provide written informed consent. Patients currently receiving oral and/or topical 5-aminosalicylic acid (such as mesalamine) may continue their treatment during the study period. Exclusion Criteria: Participants will be excluded if they meet any of the following criteria: 1. Diagnosis of Crohn's disease, intestinal tuberculosis, chronic intestinal infections, or intestinal malignancies. 2. Current treatment with corticosteroids, thiopurines, biologics, or oral small molecules. 3. Severe skin conditions or infections. 4. Presence of severe underlying medical conditions, including but not limited to cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic disorders, autoimmune diseases, communicable diseases, severe malnutrition, or malignancies. 5. Mental illness, cognitive dysfunction, or language disorders. 6. Receipt of acupuncture therapy for UC within the past month. 7. Substance abuse issues. 8. Pregnancy, plans to become pregnant within the next year, lactation, or being within 12 months postpartum.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.