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Evaluation of the therapeutic effect of portable transcutaneous electrical stimulation device on chronic constipation

Evaluation of the therapeutic effect of portable transcutaneous electrical stimulation device on chronic constipation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096081
Enrollment
Unknown
Registered
2025-01-17
Start date
2023-11-16
Completion date
Unknown
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic constipation

Interventions

Zusanli electrical stimulation group:Electrical stimulation

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: l. Subjects who fully understand and are willing to comply with the trial procedures, voluntarily participate in this trial and sign the informed consent form; 2. 18= 2 days per week; b. Complete diary card records for at least 10 days; c. Take emergency medication (bisacodyl) continuously or intermittently for <= 2 days; d. Subjects who can maintain stable living and eating habits during the trial and do not make any new major changes that may affect IBS-C, FC symptoms (for example, starting a new diet, or changing usual living habits). e. Normal colonoscopy reports from domestic third-level or above hospitals within two years or abnormal results that the researchers believe are of no clinical significance (such as chronic colitis diagnosed due to congestion and edema, but without erosive ulcers; colon polyps with a diameter of less than or equal to 3mm and less than 5 pieces).

Exclusion criteria

Exclusion criteria: If the subject meets any of the following exclusion criteria during the assessment, he or she will be excluded from the study: 1. Subjects with gastrointestinal alarm symptoms within 14 days before screening, such as blood in stool, positive fecal occult blood test, anemia, abdominal mass, ascites, fever, unexplained weight loss, and nocturnal diarrhea; 2. Subjects with a previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (except polyps = 15 days ago), intestinal diverticula, intestinal tumors, etc., or those who are still suffering from peptic ulcers and infectious diarrhea; 3. Subjects with a previous diagnosis of diseases that affect the digestive system function, such as uncontrolled hyperthyroidism or hypothyroidism, chronic renal insufficiency, autoimmune diseases, diabetes, neurosis (such as anorexia nervosa, etc.) or severe mental illness (such as severe depression or severe anxiety), etc.; 4. Subjects with a previous diagnosis of IBS Diseases with similar symptoms, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; 5. Patients with a previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.; 6. Patients with a history of digestive system surgery (except appendectomy and intestinal polypectomy), such as cholecystectomy, etc.; 7. Patients with a history of severe cardiovascular and cerebrovascular diseases, hematopoietic system diseases or tumors; 8. Suspected or confirmed history of alcohol or drug abuse; 9. Abnormal electrocardiogram results during the screening period or baseline: 10. From the signing of the informed consent form to the end of the observation period, drugs that affect gastrointestinal motility and function, such as prokinetics, anticholinergics, calcium channel blockers, 5-HT3 Receptor antagonists, antidiarrheals, antacids, antidepressants, antianxiety drugs, intestinal flora regulating drugs and antibiotics, etc. 11. Subjects who have participated in any clinical trial and received treatment in the past 3 months; 12. Pregnant or lactating women; 13. From the signing of the informed consent form to 4 weeks after the last treatment, the subject or the subject's partner plans to become pregnant during the trial or is unwilling to take reliable contraceptive measures for contraception; 14. Subjects who have undergone pacemaker or stent implantation; 15. Familiar with acupuncture treatment, acupoints or meridians; 16. The researcher believes that the subject has other conditions that are not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Number of complete spontaneous bowel movements per week;

Secondary

MeasureTime frame
Spontaneous bowel movements per week;

Countries

China

Contacts

Public ContactLiu Shi

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

1455019296@qq.com+86 138 7116 2084

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026