An interventional study of Acupuncture and Transcutaneous Electrical Acupoint Stimulation in IBS, Constipation Predominant and Anxiety State, sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by The First Affiliated Hospital of Zhejiang Chinese Medical University · Not applicable, Interventional, and Treatment
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.
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.
24 studies on the registry are indexed under Ichthyosis Bullosa of Siemens; 6 are open to participants now.
This study's planned enrollment of 58 is below the median of 88 across 18 interventional studies indexed under Ichthyosis Bullosa of Siemens.
Browse Ichthyosis Bullosa of Siemens studies →The First Affiliated Hospital of Zhejiang Chinese Medical University is the lead sponsor of 40 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: Acupuncture · Device: Transcutaneous Electrical Acupoint Stimulation
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.
Procedure: Acupuncture · Device: Sham Transcutaneous Electrical Acupoint Stimulation
Participants receive standardized acupuncture once weekly for 4 weeks.
Participants receive daily 1-hour stimulation for 4 weeks, with stimulation applied to unilateral ST36 (Zusanli).
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.
Weekly complete spontaneous bowel movements (CSBM)
The number of complete spontaneous bowel movements recorded in the final observation week of intervention period.
Time frame: Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8
Number of participants with acupuncture-related adverse reactions
Count of participants who experience acupuncture-related adverse reactions during the study period.
Time frame: 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.
Time frame: from baseline to Week 4
Number of participants with other adverse events
Count of participants experiencing adverse events unrelated to acupuncture or TEAS.
Time frame: from baseline to Week 4
Number of participants with serious adverse events
Count of participants who experience serious adverse events throughout the study.
Time frame: from baseline to Week 4
Acupuncture completion rate
Proportion of participants who complete all scheduled acupuncture sessions.
Time frame: from baseline to Week 4
TEAS/sham-TEAS completion rate
Proportion of participants who complete the scheduled home TEAS or sham TEAS intervention.
Time frame: from baseline to Week 4
Change in fecal gut microbiota composition assessed by 16S rRNA gene sequencing
Change of fecal gut microbiota detected by 16S rRNA gene sequencing, including alpha-diversity, beta-diversity and taxa relative abundance. Calculated as Week 4 value minus baseline value.
Time frame: Baseline, Week 4
Change in Low Frequency (LF) power
Autonomic nerve function was assessed by frequency-domain HRV parameter low frequency (LF), which mainly reflects combined sympathetic and parasympathetic activity. Twenty-four-hour ambulatory electrocardiography (Holter) or other valid ECG recording devices was used to collect continuous ECG data for HRV analysis.
Time frame: Baseline, Week 4
Change in High Frequency (HF) power
Autonomic nerve function was assessed by frequency-domain HRV parameter high frequency (HF), which mainly reflects parasympathetic activity. Twenty-four-hour ambulatory electrocardiography (Holter) or other valid ECG recording devices was used to collect continuous ECG data for HRV analysis.
Time frame: Baseline, Week 4
Change in LF/HF ratio
The LF/HF ratio was calculated to represent the balance of the autonomic nervous system. Twenty-four-hour ambulatory electrocardiography (Holter) or other valid ECG recording devices was used to collect continuous ECG data for HRV analysis.
Time frame: Baseline, Week 4
No study locations are listed for this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Ichthyosis Bullosa of Siemens →
The First Affiliated Hospital of Zhejiang Chinese Medical University