Dose-Effect Response in Acupuncture for Functional Constipation
ConditionFunctional Constipation (FC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Meet Rome IV diagnostic criteria for functional constipation
Symptoms present for ≥6 months, meeting diagnostic criteria in the last 3 months
Mean weekly complete spontaneous bowel movements (CSBMs) ≤2 during 14-day baseline period
Age 18-75 years
Disqualifiers
Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or gastrointestinal surgery)
Loose or watery stools (Bristol type 6 or 7) >1 time during baseline without laxative use
History of pelvic floor dysfunction
Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment (2-week washout required)
Trial design
Treatments tested in this trial
- Manual Acupuncture
- Electroacupuncture
Treatment groups
72 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov