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A Pilot Randomized Controlled Clinical Study of Acupuncture Treatment for Irritable Bowel Syndrome with Anxiety and Depression

A Pilot Randomized Controlled Clinical Study of Acupuncture Treatment for Irritable Bowel Syndrome with Anxiety and Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002100
Enrollment
Unknown
Registered
2025-11-04
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

irritable bowel syndrome

Interventions

true acupuncture group:acupuncture on specific acupoints
sham acupuncture group:shallow acupuncture on non-acupoints

Sponsors

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: I. Individuals aged 18 to 75 years, regardless of gender; II. Subjects meeting the Rome IV diagnostic criteria for irritable bowel syndrome (IBS); III. Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score =75 points and Hospital Anxiety and Depression Scale (HADS) score =11 points; IV. No suicidal behavior within the past 3 months or Revised Suicide Behavior Questionnaire (SBQ-R) score <7 points; V. Potential subjects must not have received acupuncture treatment for IBS or taken psychiatric medications within the past six months; VI. If subjects are currently taking medications to alleviate IBS symptoms (e.g., traditional Chinese medicine, proprietary Chinese medicines, antidiarrheals, antispasmodics, intestinal antibiotics, or probiotic preparations) prior to treatment initiation, these must be discontinued at least two weeks before treatment begins.

Exclusion criteria

Exclusion criteria: 1) Organic intestinal diseases such as inflammatory bowel disease, microscopic colitis, celiac disease history, or Crohn's disease; 2) Diabetes mellitus, thyroid dysfunction; 3) Severe acute/chronic organic diseases, renal disease, or hepatic disease; 4) History of abdominal surgery (patients with appendectomy, hemorrhoidectomy, or polypectomy performed over 3 months prior may be included); 5) Pregnancy or lactation; 6) History of alcohol or substance abuse; 7) Patients currently participating in other clinical trials, etc.

Design outcomes

Primary

MeasureTime frame
the effective response rate;

Secondary

MeasureTime frame
IBS-SSS;HADS;Abdominal pain;Satisfaction of bowel habits;

Countries

China

Contacts

Public ContactLingyu Qi

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

qly66love@163.com18265615112

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 24, 2026