Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT06615765 for Ulcerative Colitis is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Acupuncture for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis 64 Randomized
Clinical Trial NCT06615765 is an interventional study for Ulcerative Colitis and is currently not yet recruiting. Enrollment is planned to begin on 1 November 2024 and continue until the study accrues 64 participants. Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences, this study is expected to complete by 31 October 2026. The latest data from ClinicalTrials.gov was last updated on 27 September 2024.
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 i...Show More
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 an...Show More
Official Title
Efficacy and Safety of Two-step Acupuncture Therapy for Symptom Relief in Adults with Mild to Moderate Ulcerative Colitis
Conditions
Ulcerative ColitisPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- 2024-190-KY
NCT ID Number
Start Date (Actual)
2024-11-01
Last Update Posted
2024-09-27
Completion Date (Estimated)
2026-10-31
Enrollment (Estimated)
64
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Acupuncture
Ulcerative colitis
Patient-reported outcome 2
Inflammatory bowel disease
Randomized controlled trial
Ulcerative colitis
Patient-reported outcome 2
Inflammatory bowel disease
Randomized controlled trial
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAcupuncture group 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 ...Show More | 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,...Show More |
Sham ComparatorSham acupuncture group 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...Show More | 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...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
change from baseline in the PRO2 score | Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). The primary outcome is the change from baseline in the PRO2 score at week 8. | Week 8 after randomization |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
The proportion of patients achieving a ≥ 50% reduction in PRO2 score at weeks 4, 8, 12, 16, 20, 24, 28, and 32. | Weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization. | |
The proportion of patients with a PRO2 score of 0 | At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization. | |
Changes from baseline in weekly average U-NRS scores | Since bowel urgency is an independent and critical symptom impacting patients' quality of life and productivity, this study will assess bowel urgency severity using the Numeric Rating Scale (U-NRS) (0 = no urgency, 10 = worst possible urgency). The minimal clinically important difference (MCID) is defined as a ≥3-point decrease in U-NRS from baseline, while bowel urgency remission is defined as a U-NRS score of 0 or 1. In this study, patients will be instructed to record their scores for each bowel movement. The average U-NRS score will be calculated weekly by summing the U-NRS scores for the week and dividing by the total number of bowel movements. | At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization. |
Changes from baseline in weekly average NRS scores for abdominal pain associated with bowel movements | For the NRS score related to abdominal pain associated with bowel movements (scale 0 to 10, with higher scores indicating more severe pain), patients will record their scores for each bowel movement. The weekly average NRS score will be derived by summing these scores and dividing by the total number of bowel movements. | At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization. |
Changes from baseline in weekly average NRS scores for abdominal pain not associated with bowel movements | For the NRS score related to abdominal pain not associated with bowel movements (scale 0 to 10, with higher scores indicating more severe pain), patients will record daily scores, which will then be summed over the week and divided by 7 to obtain the weekly average NRS score. | At weeks 4, 8, 12, 16, 20, 24, 28, and 32 after randomization. |
Changes from baseline in IBDQ-32 scores | The IBDQ-32 is the predominant tool for assessing disease-specific quality of life in randomized clinical trials for UC. Studies support the efficacy of IBDQ-32 in capturing treatment impacts on the quality of life of UC patients. The questionnaire encompasses four domains reflecting the impact of UC on patients: symptoms, psychological and social functioning, and physical and emotional well-being. | At weeks 4, 8, 12, 20, and 32 after randomization. |
Changes from baseline in WPAI-IBD scores | The WPAI-IBD (version 2.0) (www.reillyassociates.net), is a validated tool designed to assess impairments in work and daily activities. This 6-item questionnaire evaluates impairments experienced over the past 7 days and provides four key metrics: 1) Absenteeism (percentage of work time missed); 2) Presenteeism (percentage of impairment while at work); 3) Overall work productivity loss (combined estimate of absenteeism and presenteeism); and 4) Activity impairment (percentage of impairment in daily activities). WPAI-IBD results are reported as percentages, with higher scores reflecting greater impairment and reduced productivity. | At weeks 4, 8, 20, and 32 after randomization. |
Changes from baseline in PSQI scores | The Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire that assesses sleep quality and disturbances over the past month, with higher scores indicating worse sleep quality. | At weeks 8, 20, and 32 after randomization. |
Changes from baseline in HADS scores | The Hospital Anxiety and Depression Scale (HADS) is a self-report tool designed to identify symptoms of depression and anxiety, with higher scores reflecting more severe symptoms. | At weeks 8, 20, and 32 after randomization. |
PGIC | The Patient Global Impression of Change (PGIC) will be used to evaluate overall improvement. This simple, patient-reported outcome measures participants\' perceptions of changes in their condition using a 7-point scale: "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | At weeks 4, 8, 20, and 32 after randomization. |
Changes from baseline in the PRO2 score | Data on daily bowel movements and rectal bleeding will be summarized from the stool diaries. The PRO2 score, assessed at weeks 4, 8, 12, 16, 20, 24, 28, and 32, comprises the Stool Frequency (SF) and Rectal Bleeding (RB) subscales of the Mayo score. The SF subscale is rated as follows: 0 (normal stool frequency), 1 (1-2 stools more than normal), 2 (3-4 stools more than normal), and 3 (5 or more stools more than normal). The RB subscale is rated as: 0 (no blood), 1 (streaks of blood less than half the time), 2 (obvious blood most of the time), and 3 (blood alone). | Weeks 4, 12, 16, 20, 24, 28, and 32 after randomization |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
Participants will be excluded if they meet any of the following criteria:
- Diagnosis of Crohn's disease, intestinal tuberculosis, chronic intestinal infections, or intestinal malignancies.
- Current treatment with corticosteroids, thiopurines, biologics, or oral small molecules.
- Severe skin conditions or infections.
- 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.
- Mental illness, cognitive dysfunction, or language disorders.
- Receipt of acupuncture therapy for UC within the past month.
- Substance abuse issues.
- Pregnancy, plans to become pregnant within the next year, lactation, or being within 12 months postpartum.
Guang'anmen Hospital of China Academy of Chinese Medical SciencesStudy Responsible Party
He Chen, Principal Investigator, Researcher, Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Principal Investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Central Contact
Contact: He Chen, bachelor of medicine, +86 19927523321, [email protected]
No location data.