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Acupuncture treatment for the visceral hypersensitivity and intestinal mucosal immunoinflammation of patients with IBS-D: a randomized controlled clinical trial

Acupuncture treatment for the visceral hypersensitivity and intestinal mucosal immunoinflammation of patients with IBS-D: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000770
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-04-26
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Acupuncture Group:Puncturing at Zhongwan (CV12), Tianshu (ST25), Zusanli (ST36) and Taichong (LR3) with filiform needles, performing needling manipulation to get Deqi sensation, and retaining for 30
Sham Acupuncture Group:Applying the blunt-tipped needles at four non-acupoints without needling insertion, nor Deqi sensation, retaining for 30 minutes
Healthy Control Group:No acupuncture treatment in the Healthy Control Group

Sponsors

School of Acupuncture and Tuina Chengdu University of Chinese Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1)Patient inclusion criteria 1) Aged between 18 and 60 years old both male and female; 2) Meeting the Rome IV diagnostic criteria of IBS-D; 3) With type 6 or 7 of the Bristol Stool Form Scale for at lest 4 days and type 1 or 2 for less than 4 days in the last week; suffering from the average score of daily abdominal pain = 3 in the last week; 4) Voluntarily agree to undergo colonoscopy and intestinal sample collection before or after treatment; 5) Voluntarily agree to undergo serum inflammatory factor testing before or after treatment; 6) No acupuncture treatment received in the past six months; 7) No use of IBS-D-related medications in the week prior to treatment including Western medications (e.g. antidiarrheals antispasmodics antibiotics probiotics) or traditional Chinese medicines/herbal formulations. (2) Inclusion Criteria for Healthy Participants 1) Aged between 18 and 60 years old both male and female; 2) Maintain regular and healthy lifestyle habits without harmful behaviors; 3) No congenital disease or acquired disease no clinically significant biochemical changes; 4) No gastrointestinal symptoms body pain or other functional disorders; 5) No colonoscopy was performed 3 months before the collection of intestinal specimens; 6) No acupuncture treatment antibiotics probiotics antidepressants or gastrointestinal-related medications (therapeutic or side-effect-inducing) used within 14 days before intestinal sample collection; 7) Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Contraindications of colonoscopy; 2) Presence of organic lesions identified during colonoscopy; 3) History of constipation-predominant IBS (IBS-C) mixed-type IBS (IBS-M) celiac disease Crohns disease ulcerative colitis or other organic bowel disorders; 4) Patients with a history of abdominal and gastrointestinal surgery; 5) Diabetes thyroid dysfunction and heart liver kidney hematopoietic system and other serious acute/chronic organic diseases; 6) Pregnancy or lactation; 7) History of alcohol and drug abuse; 8)Patients participating in other clinical trials. Participants meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Effective response rate at the week-6 of treatment;

Secondary

MeasureTime frame
Patient's Bowel Movement Status;IFN-?;TNF-a;IL-1ß;Severity of symptoms associated with IBS.;Quality of life in IBS patient.;Self-Rating Anxiety Scale (SAS);Self - Rating Depression Scale (SDS);IL-17;IL-6;

Countries

China

Contacts

Public ContactZheng Qianhua

School of Acupuncture and Tuina Chengdu University of Chinese Traditional Medicine

zhengqianhua@cdutcm.edu.cn+86 18215638908

Outcome results

None listed

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