Functional Constipation (FC)NCT07506122
Dose-Effect Response in Acupuncture for Functional Constipation
A study testing Manual Acupuncture and Electroacupuncture in people with Functional Constipation (FC), run by Tongji Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Constipation (FC)
- What is being tested?
- Manual Acupuncture and Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesChina
- Study dates
- 11 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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)
- Severe hemorrhoids or anal fissures
- Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders
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- Dependence on opioids or anticholinergic drugs
- Red flags: unexplained weight loss >10% in 3 months, hematochezia or positive fecal occult blood, family history of colon cancer (first-degree relative diagnosed <50 years), anemia (Hb <110 g/L), or elevated inflammatory markers
- Contraindications to acupuncture: coagulation disorders or use of anticoagulants
- Pregnancy or breastfeeding
- Unable to comply with follow-up or contraindications to MRI (e.g., cardiac pacemaker, non-titanium aneurysm clips, metallic implants, claustrophobia)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Wensheng Qu, +86-18971622660, Qws0309@163.com
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Wensheng Qu, +86-18971622660, Qws0309@163.com
About this study
Official title: Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study
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).
Read more
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
- Functional Constipation (FC)
- Being tested
- Manual Acupuncture, Electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual AcupunctureOther
Acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Needles are retained for 30 minutes. After removal, needle holes are pressed to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks.
ElectroacupunctureDevice
Acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Then needles are connected to an electroacupuncture device (Hwato SDZ-III, Suzhou Medical Products Factory, China). Two pairs of electrodes are attached: one pair to bilateral Tianshu (ST25), the other to bilateral Shangjuxu (ST37). Electrical stimulation: continuous wave, 10 Hz, current intensity 0.5-4 mA adjusted to patient tolerance. Electroacupuncture duration: 30 minutes. After needle removal, press to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Manual Acupuncture Group | Experimental | Not described Receives: Other: Manual Acupuncture |
| Electroacupuncture Group | Experimental | Not described Receives: Device: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder Rate at Week 12
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12
Measured: Week 12
Secondary outcomes (9)
Responder Rate at Week 16
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 16
Measured: Week 16
Changes in Blood Flow Measured by DCS
Changes in blood flow at acupoints, intestinal body surface projection areas, and abdominal muscle tissue measured by diffuse correlation spectroscopy (DCS), with concurrent monitoring of local pressure and temperature
Measured: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Changes in Gut Microbiota
Changes in gut microbiota diversity and composition analyzed by 16S rRNA sequencing, and changes in gut metabolites (e.g., short-chain fatty acids) measured by targeted metabolomics
Measured: Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in Brain Function
Changes in central neural network connectivity, functional activity of core brain regions, and brain glymphatic system function assessed by multimodal MRI
Measured: Baseline, after deqi, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in Cortical Activity Measured by fNIRS
Changes in cortical activity assessed by functional near-infrared spectroscopy (fNIRS)
Measured: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Acupuncture Expectancy Scale
A 4-item patient-reported questionnaire assessing patients' expectancy of positive outcomes from acupuncture therapy, including improvement of illness, enhanced coping, increased vitality, and symptom alleviation. Each item is scored from 1 (not at all agree) to 5 (completely agree), with total scores ranging from 4 to 20. Higher scores indicate greater expectancy of benefit from acupuncture treatment.
Measured: Baseline
Patient Assessment of Constipation Quality of Life
A 28-item patient-reported questionnaire assessing constipation-related quality of life, consisting of four domains: physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction. Each item is scored from 0 to 4, with total scores ranging from 0 to 112. Higher scores indicate worse constipation-related quality of life.
Measured: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Generalized Anxiety Disorder 7-item Scale
A 7-item patient-reported questionnaire assessing anxiety symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms.
Measured: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Patient Health Questionnaire-9
A 9-item patient-reported questionnaire assessing depressive symptoms over the past two weeks, based on the DSM-IV diagnostic criteria for depression. Each item is scored from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27. Higher scores indicate more severe depressive symptoms.
Measured: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start11 May 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Constipation (FC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Shabei, Tongji Hospital
- Investigators
- Shabei Xu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506122
- Sponsor's protocol ID
- TJ-IRB202603096
- Status last verified
- May 2026
- First submitted
- 26 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07506122
- Acronym / sponsor ID
- TJ-IRB202603096
- Conditions
- Functional Constipation (FC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Acupuncture Group | Experimental | Other: Manual Acupuncture |
| Electroacupuncture Group | Experimental | Device: Electroacupuncture |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)
Key exclusion criteria (11 listed)
- 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)
- Severe hemorrhoids or anal fissures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual AcupunctureAcupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Needles are retained for 30 minutes. After removal, needle holes are pressed to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks. | Other | Manual Acupuncture Group |
| ElectroacupunctureAcupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37). Participant lies supine and rests for 5 minutes before treatment. After routine disinfection, the acupuncturist inserts needles vertically to a certain depth, followed by mild lifting, thrusting, and twisting for 10 seconds at each acupoint to induce deqi. Then needles are connected to an electroacupuncture device (Hwato SDZ-III, Suzhou Medical Products Factory, China). Two pairs of electrodes are attached: one pair to bilateral Tianshu (ST25), the other to bilateral Shangjuxu (ST37). Electrical stimulation: continuous wave, 10 Hz, current intensity 0.5-4 mA adjusted to patient tolerance. Electroacupuncture duration: 30 minutes. After needle removal, press to prevent bleeding. Treatment frequency: three sessions per week for 12 weeks. | Device | Electroacupuncture Group |
Primary outcome
Responder Rate at Week 12
Time frame: Week 12
Percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week at week 12
9 secondary outcomes
Responder Rate at Week 16
Time frame: Week 16
Changes in Blood Flow Measured by DCS
Time frame: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Changes in Gut Microbiota
Time frame: Baseline, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in Brain Function
Time frame: Baseline, after deqi, week 12, week 16, and at the time when CSBMs ≥3 per week is achieved
Changes in Cortical Activity Measured by fNIRS
Time frame: Baseline, after deqi, weeks 2, 4, 6, 8, 10, 12, 16
Acupuncture Expectancy Scale
Time frame: Baseline
Patient Assessment of Constipation Quality of Life
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Generalized Anxiety Disorder 7-item Scale
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Patient Health Questionnaire-9
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shabei Xu principal investigator
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Acupuncture and Electroacupuncture in people with Functional Constipation (FC), run by Tongji Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wensheng Qu (+86-18971622660, Qws0309@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder Rate at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.