IBS, Constipation PredominantNCT07899944
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
A study testing Acupuncture and Transcutaneous Electrical Acupoint Stimulation in people with IBS, Constipation Predominant and Anxiety State, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
Trial summary
Study Title: Randomized Controlled Clinical Study on Acupuncture Combined with Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome with Anxiety State. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS, Constipation Predominant, Anxiety State
- What is being tested?
- Acupuncture and Transcutaneous Electrical Acupoint Stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years, with no restriction on gender.
- Meeting the Rome V diagnostic criteria for IBS-C.
- Stable constipation phenotype during the screening period; participants are expected to have fewer than 3 CSBMs per week, or be judged by the investigator to present constipation features consistent with IBS-C.
- IBS-SSS score ≥ 175, indicating at least moderate IBS symptoms.
- HADS-A score ≥ 8, indicating the presence of anxiety status.
- Stable regimens of IBS-related medications, anxiolytic/antidepressant agents and other treatments that may affect gastrointestinal motility for at least 2 weeks prior to enrollment; participants are willing to avoid adding relevant new treatments during the study period.
- Able to understand study procedures and willing to complete acupuncture treatment, home-based TEA/sham-TEA therapy, symptom diaries and follow-up assessments.
- Voluntarily participate in the study and provide written informed consent.
Who cannot join
- Presence of organic diseases that could account for symptoms, including inflammatory bowel disease, colorectal neoplasm, intestinal obstruction, coeliac disease, uncontrolled thyroid disease, and diabetic autonomic neuropathy.
- Presence of alarm features such as hematochezia, unexplained weight loss, anemia, fever, nocturnal symptoms, and family history of colorectal cancer without completion of necessary diagnostic work-up.
- Previous major abdominal surgery that may significantly impair intestinal function.
- Severe mental disorders, bipolar disorder, psychotic symptoms, substance dependence, significant suicide risk, or conditions requiring immediate psychiatric intervention.
- New initiation or dose adjustment of anxiolytics, antidepressants, antipsychotics, opioids, strong anticholinergic agents, prokinetics, or regular laxatives within 4 weeks prior to screening.
- Implanted cardiac pacemaker, implantable cardioverter-defibrillator or other implanted electronic devices, or presence of unstable arrhythmia.
Show all 11Show fewer
- Skin breakdown, infection, severe skin disease at TEA electrode sites, or allergy to electrode materials.
- Contraindications to acupuncture, such as severe coagulopathy, inability to tolerate acupuncture, or extremely high risk of acupuncture syncope.
- Pregnancy, lactation, or planned pregnancy during the study period.
- Participation in another interventional clinical trial within the past 3 months.
- Other conditions judged by the investigator to render the participant unsuitable for this study.
About this study
Official title: Randomized Controlled Clinical Study on Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
Study Title: Randomized Controlled Clinical Study on Acupuncture Combined with Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome with Anxiety State.
This single-center, randomized, single-blinded sham-controlled trial enrolls adults aged 18-70 with constipation-predominant irritable bowel syndrome (IBS-C) and anxiety. All participants receive standardized weekly acupuncture for 4 weeks. Participants are randomly assigned 1:1 to either real daily home Transcutaneous Electrical Acupoint Stimulation(TEAS)at Zusanli acupoint or sham non-acupoint TEAS. The total study period lasts approximately 10 weeks, including 2-week screening, 4-week intervention and 4-week post-treatment follow-up.
The primary outcome is weekly complete spontaneous bowel movements (CSBM) at week 4. Secondary outcomes cover anxiety, sleep quality, abdominal symptoms, quality of life and safety. Researchers will test whether adding real home-based TEAS to acupuncture improves bowel and emotional symptoms, and evaluate treatment safety and tolerability.
Read the detailed description
Constipation-predominant irritable bowel syndrome (IBS-C) is frequently accompanied by anxiety, which exacerbates gastrointestinal symptoms and reduces quality of life. This condition involves complex gut-brain interactions, including autonomic nervous system dysregulation and visceral hypersensitivity. Both acupuncture and Transcutaneous Electrical Acupoint Stimulation (TEAS) have shown potential in regulating gastrointestinal motility and emotional states. However, outpatient acupuncture alone often faces challenges such as interrupted treatment courses. This study aims to evaluate the synergistic effect, safety, and potential autonomic and microbiome mechanisms of combining standardized manual acupuncture with daily home-based TEAS for IBS-C patients with anxiety.
Common Acupuncture Treatment (Both Groups): All participants will receive standardized manual acupuncture once a week for 4 weeks. The acupoints include bilateral Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), Taichong (LR3), as well as Baihui (GV20) and Yintang (EX-HN3). Sterile disposable acupuncture needles (0.25×40mm) will be used. The needles will be manipulated to achieve "Deqi" (a sensation of soreness, numbness, distention, or heaviness), and retained for 30 minutes per session.
- Experimental Group (Acupuncture + Real TEAS): Concurrently with acupuncture, participants will receive daily 1-hour home-based real TEAS applied to unilateral Zusanli (ST36). The stimulation parameters will be set at a frequency of 25 Hz, a pulse width of 0.5 ms, and an intermittent mode of 2 seconds on / 3 seconds off. The intensity will be adjusted to the maximum tolerable level that produces a distinct but painless stimulation sensation.
- Sham Comparator Group (Acupuncture + Sham TEAS): Concurrently with acupuncture, participants will receive daily 1-hour home-based sham TEAS. The sham device, electrodes, and operational procedures will be identical in appearance to the real device. However, the stimulation will be applied to a non-acupoint site located 10 cm below and 2-4 cm lateral to ST36 (avoiding major meridians and neurovascular bundles). The intensity will be set to a perceptible surface stimulation, avoiding typical Deqi sensations or muscle contractions.
- Conditions
- IBS, Constipation Predominant, Anxiety State
- Being tested
- Acupuncture, Transcutaneous Electrical Acupoint Stimulation, Sham Transcutaneous Electrical Acupoint Stimulation
- Medical subject headings
- Ichthyosis Bullosa of Siemens, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Participants receive standardized acupuncture once weekly for 4 weeks.
Transcutaneous Electrical Acupoint StimulationDevice
Participants receive daily 1-hour stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli).
Sham Transcutaneous Electrical Acupoint StimulationDevice
Participants receive daily 1-hour sham stimulation for 4 weeks, with stimulation applied to a non-acupoint site distant from ST36 (Zusanli) and not located along major meridians.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Participants receive standardized acupuncture once weekly for 4 weeks, together with daily 1-hour Transcutaneous Electrical Acupoint Stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli). Receives: Procedure: Acupuncture; Device: Transcutaneous Electrical Acupoint Stimulation |
| Sham Comparator Arm | Sham comparator | Participants receive standardized acupuncture once weekly for 4 weeks, together with daily 1-hour sham Transcutaneous Electrical Acupoint Stimulation for 4 weeks, with stimulation applied to a non-acupoint site distant from ST36 (Zusanli) and not located along major meridians. Receives: Procedure: Acupuncture; Device: Sham Transcutaneous Electrical Acupoint Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly complete spontaneous bowel movements (CSBM)
The number of complete spontaneous bowel movements recorded in the final observation week of intervention period.
Measured: Week 4
Secondary outcomes (28)
Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score
Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms.
Measured: Baseline, Week 4
Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 5
Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms.
Measured: Baseline, Week 5
Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 8
Anxiety symptoms assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). Total score ranges from 0 to 21; higher scores indicate more severe anxiety symptoms.
Measured: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score
Depressive symptoms assessed using the 7-item Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Total score ranges from 0 to 21; higher scores indicate more severe depressive symptoms.
Measured: Baseline, Week 4
Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score at Week 8
Depressive symptoms assessed using the 7-item Depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). Total score ranges from 0 to 21; higher scores indicate more severe depressive symptoms.
Measured: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale Total score (HADS-Total)
Total emotional status evaluated by the total score of Hospital Anxiety and Depression Scale, summing HADS-A and HADS-D subscale scores. Total score ranges from 0 to 42, higher scores indicate more severe emotional distress.
Measured: Baseline, Week 4
Change in Hospital Anxiety and Depression Scale Total score (HADS-Total) at Week 8
Total emotional status evaluated by the total score of Hospital Anxiety and Depression Scale, summing HADS-A and HADS-D subscale scores. Total score ranges from 0 to 42, higher scores indicate more severe emotional distress.
Measured: Baseline, Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality.
Measured: Baseline, Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) total score at Week 8
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). Total score ranges from 0 to 21; higher scores indicate poorer sleep quality.
Measured: Baseline, Week 8
Change in IBS Symptom Severity Scale (IBS-SSS) total score
Overall IBS-related symptoms assessed using the IBS Symptom Severity Scale (IBS-SSS). Total score ranges from 0 to 500; higher scores indicate more severe symptoms.
Measured: Baseline, Week 4
Change in IBS Symptom Severity Scale (IBS-SSS) total score at Week 8
Overall IBS-related symptoms assessed using the IBS Symptom Severity Scale (IBS-SSS). Total score ranges from 0 to 500; higher scores indicate more severe symptoms.
Measured: Baseline, Week 8
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score
Quality of life assessed using the IBS-QOL. Total score ranges from 0 to 100; higher scores indicate better quality of life.
Measured: Baseline, Week 4
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score at Week 8
Quality of life assessed using the IBS-QOL. Total score ranges from 0 to 100; higher scores indicate better quality of life.
Measured: Baseline, Week 8
Weekly complete spontaneous bowel movements (CSBM) at week 5
The number of complete spontaneous bowel movements recorded during the first week after the end of intervention
Measured: Week 5
Weekly complete spontaneous bowel movements (CSBM) at week 8
The number of complete spontaneous bowel movements recorded during the first week after the end of intervention.
Measured: Week 8
Weekly spontaneous bowel movements (SBM)
The number of spontaneous bowel movements recorded during the first week after the end of intervention, without the use of laxatives.
Measured: Week 5
Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS)
Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool).
Measured: Baseline, Week 4
Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 5
Description: Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool).
Measured: Baseline, Week 5
Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 8
Stool consistency is assessed by the 7-point Bristol Stool Form Scale, with scores ranging from 1 (hard lumpy stool) to 7 (watery stool).
Measured: Baseline, Week 8
Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS)
Subject-reported intensity of abdominal pain and bloating, scored on a 0-10 visual analogue scale, 0 represents no discomfort and 10 represents the worst imaginable discomfort.
Measured: Baseline, Week 4
Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) at Week 5
Subject-reported intensity of abdominal pain and bloating, scored on a 0-10 visual analogue scale, 0 represents no discomfort and 10 represents the worst imaginable discomfort.
Measured: Baseline, Week 5
Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) at Week 8
Subject-reported intensity of abdominal pain and bloating, scored on a 0-10 visual analogue scale, 0 represents no discomfort and 10 represents the worst imaginable discomfort.
Measured: Baseline, Week 8
Number of participants with acupuncture-related adverse reactions
Count of participants who experience acupuncture-related adverse reactions during the study period.
Measured: from baseline to Week 4
Number of participants with TEAS-related skin reactions
Count of participants who develop TEAS-related skin reactions during the study period. TEAS = Transcutaneous Electrical Acupoint Stimulation.
Measured: from baseline to Week 4
Number of participants with other adverse events
Count of participants experiencing adverse events unrelated to acupuncture or TEAS.
Measured: from baseline to Week 4
Number of participants with serious adverse events
Count of participants who experience serious adverse events throughout the study.
Measured: from baseline to Week 4
Acupuncture completion rate
Proportion of participants who complete all scheduled acupuncture sessions.
Measured: from baseline to Week 4
TEAS/sham-TEAS completion rate
Proportion of participants who complete the scheduled home TEAS or sham TEAS intervention.
Measured: from baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS, Constipation PredominantStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899944
- Sponsor's protocol ID
- 2026-KLS-361-01
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Study on Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
- ClinicalTrials.gov ID
- NCT07899944
- Acronym / sponsor ID
- 2026-KLS-361-01
- Conditions
- IBS, Constipation Predominant, Anxiety State
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 28 Oct 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.
Study Title: Randomized Controlled Clinical Study on Acupuncture Combined with Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome with Anxiety State.
This single-center, randomized, single-blinded sham-controlled trial enrolls adults aged 18-70 with constipation-predominant irritable bowel syndrome (IBS-C) and anxiety. All participants receive standardized weekly acupuncture for 4 weeks. Participants are randomly assigned 1:1 to either real daily home Transcutaneous Electrical Acupoint Stimulation(TEAS)at Zusanli acupoint or sham non-acupoint TEAS. The total study period lasts approximately 10 weeks, including 2-week screening, 4-week intervention and 4-week post-treatment follow-up.
The primary outcome is weekly complete spontaneous bowel movements (CSBM) at week 4. Secondary outcomes cover anxiety, sleep quality, abdominal symptoms, quality of life and safety. Researchers will test whether adding real home-based TEAS to acupuncture improves bowel and emotional symptoms, and evaluate treatment safety and tolerability.
Detailed description
Constipation-predominant irritable bowel syndrome (IBS-C) is frequently accompanied by anxiety, which exacerbates gastrointestinal symptoms and reduces quality of life. This condition involves complex gut-brain interactions, including autonomic nervous system dysregulation and visceral hypersensitivity. Both acupuncture and Transcutaneous Electrical Acupoint Stimulation (TEAS) have shown potential in regulating gastrointestinal motility and emotional states. However, outpatient acupuncture alone often faces challenges such as interrupted treatment courses. This study aims to evaluate the synergistic effect, safety, and potential autonomic and microbiome mechanisms of combining standardized manual acupuncture with daily home-based TEAS for IBS-C patients with anxiety.
Common Acupuncture Treatment (Both Groups): All participants will receive standardized manual acupuncture once a week for 4 weeks. The acupoints include bilateral Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), Sanyinjiao (SP6), Neiguan (PC6), Taichong (LR3), as well as Baihui (GV20) and Yintang (EX-HN3). Sterile disposable acupuncture needles (0.25×40mm) will be used. The needles will be manipulated to achieve "Deqi" (a sensation of soreness, numbness, distention, or heaviness), and retained for 30 minutes per session.
- Experimental Group (Acupuncture + Real TEAS): Concurrently with acupuncture, participants will receive daily 1-hour home-based real TEAS applied to unilateral Zusanli (ST36). The stimulation parameters will be set at a frequency of 25 Hz, a pulse width of 0.5 ms, and an intermittent mode of 2 seconds on / 3 seconds off. The intensity will be adjusted to the maximum tolerable level that produces a distinct but painless stimulation sensation.
- Sham Comparator Group (Acupuncture + Sham TEAS): Concurrently with acupuncture, participants will receive daily 1-hour home-based sham TEAS. The sham device, electrodes, and operational procedures will be identical in appearance to the real device. However, the stimulation will be applied to a non-acupoint site located 10 cm below and 2-4 cm lateral to ST36 (avoiding major meridians and neurovascular bundles). The intensity will be set to a perceptible surface stimulation, avoiding typical Deqi sensations or muscle contractions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Procedure: Acupuncture, Device: Transcutaneous Electrical Acupoint StimulationParticipants receive standardized acupuncture once weekly for 4 weeks, together with daily 1-hour Transcutaneous Electrical Acupoint Stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli). |
| Sham Comparator Arm | Sham comparator | Procedure: Acupuncture, Device: Sham Transcutaneous Electrical Acupoint StimulationParticipants receive standardized acupuncture once weekly for 4 weeks, together with daily 1-hour sham Transcutaneous Electrical Acupoint Stimulation for 4 weeks, with stimulation applied to a non-acupoint site distant from ST36 (Zusanli) and not located along major meridians. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18-70 years, with no restriction on gender.
- Meeting the Rome V diagnostic criteria for IBS-C.
- Stable constipation phenotype during the screening period; participants are expected to have fewer than 3 CSBMs per week, or be judged by the investigator to present constipation features consistent with IBS-C.
- IBS-SSS score ≥ 175, indicating at least moderate IBS symptoms.
- HADS-A score ≥ 8, indicating the presence of anxiety status.
Key exclusion criteria (11 listed)
- Presence of organic diseases that could account for symptoms, including inflammatory bowel disease, colorectal neoplasm, intestinal obstruction, coeliac disease, uncontrolled thyroid disease, and diabetic autonomic neuropathy.
- Presence of alarm features such as hematochezia, unexplained weight loss, anemia, fever, nocturnal symptoms, and family history of colorectal cancer without completion of necessary diagnostic work-up.
- Previous major abdominal surgery that may significantly impair intestinal function.
- Severe mental disorders, bipolar disorder, psychotic symptoms, substance dependence, significant suicide risk, or conditions requiring immediate psychiatric intervention.
- New initiation or dose adjustment of anxiolytics, antidepressants, antipsychotics, opioids, strong anticholinergic agents, prokinetics, or regular laxatives within 4 weeks prior to screening.
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 |
|---|---|---|
| AcupunctureParticipants receive standardized acupuncture once weekly for 4 weeks. | Procedure or surgery | Experimental Arm, Sham Comparator Arm |
| Transcutaneous Electrical Acupoint StimulationParticipants receive daily 1-hour stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli). | Device | Experimental Arm |
| Sham Transcutaneous Electrical Acupoint StimulationParticipants receive daily 1-hour sham stimulation for 4 weeks, with stimulation applied to a non-acupoint site distant from ST36 (Zusanli) and not located along major meridians. | Device | Sham Comparator Arm |
Primary outcome
Weekly complete spontaneous bowel movements (CSBM)
Time frame: Week 4
The number of complete spontaneous bowel movements recorded in the final observation week of intervention period.
28 secondary outcomes
Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score
Time frame: Baseline, Week 4
Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 5
Time frame: Baseline, Week 5
Change in Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score at Week 8
Time frame: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score
Time frame: Baseline, Week 4
Change in Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score at Week 8
Time frame: Baseline, Week 8
Change in Hospital Anxiety and Depression Scale Total score (HADS-Total)
Time frame: Baseline, Week 4
Change in Hospital Anxiety and Depression Scale Total score (HADS-Total) at Week 8
Time frame: Baseline, Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Baseline, Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) total score at Week 8
Time frame: Baseline, Week 8
Change in IBS Symptom Severity Scale (IBS-SSS) total score
Time frame: Baseline, Week 4
Change in IBS Symptom Severity Scale (IBS-SSS) total score at Week 8
Time frame: Baseline, Week 8
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score
Time frame: Baseline, Week 4
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) total score at Week 8
Time frame: Baseline, Week 8
Weekly complete spontaneous bowel movements (CSBM) at week 5
Time frame: Week 5
Weekly complete spontaneous bowel movements (CSBM) at week 8
Time frame: Week 8
Weekly spontaneous bowel movements (SBM)
Time frame: Week 5
Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS)
Time frame: Baseline, Week 4
Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 5
Time frame: Baseline, Week 5
Change in Stool consistency measured by the Bristol Stool Form Scale (BSFS) at Week 8
Time frame: Baseline, Week 8
Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS)
Time frame: Baseline, Week 4
Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) at Week 5
Time frame: Baseline, Week 5
Change in Abdominal pain/distension intensity measured by a Visual Analogue Scale (VAS) at Week 8
Time frame: Baseline, Week 8
Number of participants with acupuncture-related adverse reactions
Time frame: from baseline to Week 4
Number of participants with TEAS-related skin reactions
Time frame: from baseline to Week 4
Number of participants with other adverse events
Time frame: from baseline to Week 4
Number of participants with serious adverse events
Time frame: from baseline to Week 4
Acupuncture completion rate
Time frame: from baseline to Week 4
TEAS/sham-TEAS completion rate
Time frame: from baseline to Week 4
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 28 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Transcutaneous Electrical Acupoint Stimulation in people with IBS, Constipation Predominant and Anxiety State, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.
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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly complete spontaneous bowel movements (CSBM) (time frame: Week 4). 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 28 Oct 2026.