Actively Recruiting
Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study
Led by Tongji Hospital · Updated on 2026-05-14
72
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different types of acupuncture affect people with functional constipation, a condition defined by specific criteria lasting at least six months. This study is designed as a single-center, randomized trial to understand the dose-response relationship of manual acupuncture compared to electroacupuncture. The trial also explores the biological mechanisms behind these treatments by examining changes in gut microbiota and brain activity using advanced imaging techniques. Participants are randomly assigned to one of two groups. One group receives manual acupuncture at two specific points on the body, with sessions lasting 30 minutes, three times weekly for 12 weeks. The other group receives the same acupuncture treatment combined with electrical stimulation at a set frequency and adjustable intensity for the same duration and schedule. Both treatments involve careful needle insertion techniques to induce a response called deqi. During the study, participants will be assessed regularly for bowel movement improvements, gut bacteria changes, brain function, and quality of life using various scales and imaging tests. These evaluations occur at baseline, multiple points throughout treatment, and follow-up weeks, including week 12 and 16. The main outcome measured is the percentage of participants achieving at least three complete spontaneous bowel movements per week by week 12. Safety and treatment adherence are monitored throughout the trial, which lasts approximately four months.
CONDITIONS
Brief 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
- Mean weekly complete spontaneous bowel movements (CSBMs) 2 or fewer during 14-day baseline period
- Age between 18 and 75 years
- No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)
- No acupuncture treatment for constipation in the past 3 months
- Not currently participating 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 IBS, organic diseases, medications, endocrine, metabolic, neurological disorders, or gastrointestinal surgery
- Loose or watery stools (Bristol type 6 or 7) more than once during baseline without laxative use
- History of pelvic floor dysfunction
- Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment
- Severe hemorrhoids or anal fissures
- Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders
- Dependence on opioids or anticholinergic drugs
- Unexplained weight loss over 10% in 3 months, blood in stool, family history of early colon cancer, anemia, or elevated inflammatory markers
- Coagulation disorders or use of anticoagulants
- Pregnancy or breastfeeding
- Unable to comply with follow-up or contraindications to MRI such as pacemakers, metal implants, or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive acupuncture treatment at specific acupoints three times per week for 12 weeks. Treatments involve needle insertion with manual or electroacupuncture stimulation lasting 30 minutes per session.
Three sessions per week
Duration - 4 weeks
Participants are monitored after treatment completion to assess sustained effects and changes in symptoms and biological measures up to 4 weeks after treatment ends.
Visits at Week 16
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
S
Shabei Xu
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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