Actively Recruiting
Dose-Effect Response in Acupuncture for Functional Constipation
Led by Tongji Hospital · Updated on 2026-05-14
72
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, randomized, parallel-group trial evaluating the dose-response relationship of two experimental interventions: manual acupuncture and electroacupuncture for functional constipation. A total of 72 participants with functional constipation (Rome IV criteria) will be randomly assigned in a 1:1 ratio to either the manual acupuncture group or the electroacupuncture group. Both groups receive acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37) points, 30 minutes per session, three times per week for 12 weeks. The electroacupuncture group additionally receives electrical stimulation (continuous wave, 10 Hz, 0.5-4 mA). The primary outcome is the responder rate at week 12, defined as the percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and scales. The study aims to clarify the dose-response characteristics of different acupuncture modalities and their underlying biological mechanisms.
CONDITIONS
Official Title
Dose-Effect Response in Acupuncture for Functional Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet Rome IV diagnostic criteria for functional constipation
- Symptoms present for at least 6 months, meeting diagnostic criteria in the last 3 months
- Have 2 or fewer complete spontaneous bowel movements per week during a 14-day baseline period
- Aged between 18 and 75 years
- No use of constipation medications for at least 2 weeks before treatment (except rescue medication)
- No acupuncture treatment for constipation in the past 3 months
- Not currently enrolled in another clinical trial
- Willing and able to provide written informed consent
You will not qualify if you...
- Constipation caused by other conditions such as irritable bowel syndrome, organic diseases, medications, endocrine or metabolic disorders, neurological disorders, or gastrointestinal surgery
- Experience loose or watery stools (Bristol type 6 or 7) more than once during baseline without laxative use
- History of pelvic floor dysfunction
- Used probiotics, fiber supplements, or laxatives within 2 weeks before treatment (requires 2-week washout)
- Have severe hemorrhoids or anal fissures
- Have severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; enlarged liver or spleen; cognitive or psychiatric disorders
- Dependence on opioids or anticholinergic drugs
- Presence of red flags such as unexplained weight loss over 10% in 3 months, blood in stool or positive fecal occult blood test, family history of colon cancer diagnosed before age 50, anemia (hemoglobin below 110 g/L), or high inflammatory markers
- Contraindications to acupuncture like bleeding disorders or anticoagulant use
- Pregnancy or breastfeeding
- Unable to comply with follow-up or have contraindications to MRI (e.g., pacemaker, metal implants, claustrophobia)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Not Yet Recruiting
2
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
W
Wensheng Qu
CONTACT
S
Shabei Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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