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Clinical study of Gui-Shao San Umbilical Moxibustion for diarrhea-predominant Irritable Bowel Syndrome with Liver Depression and Spleen Deficiency Pattern

Clinical study of Gui-Shao San Umbilical Moxibustion for diarrhea-predominant Irritable Bowel Syndrome with Liver Depression and Spleen Deficiency Pattern

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001072
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-02-11
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Irritable bowel syndrome

Interventions

Intervention group 1:Oral trimetbutine maleate capsules plus mimetic umbilical moxibustion
Control group:Oral trimeibutine maleate capsules
Intervention group 2:Oral administration of trimeibutin maleate capsules plus Gui Shaosan umbilical moxibustion

Sponsors

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western medical diagnostic criteria of IBS-D and the TCM syndrome differentiation of liver depression and spleen deficiency syndrome in TCM; (2) Age 18~59 years old conscious; (3) Patients with informed consent and voluntary participation in this study.

Exclusion criteria

Exclusion criteria: (1) Patients with organic lesions of the gastrointestinal tract such as moderate to severe peptic ulcer erosion swelling cancer intestinal metaplasia or dysplasia; (2) Patients with severe cardiovascular and cerebrovascular liver kidney and other primary diseases coagulation dysfunction and tumors; (3) Psychiatric patients and patients with severe neurosis; (4) Women who are pregnant lactating or planning to become pregnant; (5) Those who have taken antibiotics or probiotic preparations or gastrointestinal prokinetic drugs within 1 month before the inclusion of the trial; (6) Patients with poor compliance with medical instructions and intolerance to moxibustion; (7) Those with allergies and allergies to the ingredients of medicinal powder; (8) Patients who are participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
TCM Pattern Grading Criteria;self-rating anxiety scale(SAS);self-rating depression scale(SDS);TCM Clinical Symptom Score;IBS Quality of Life Scale Score (IBS-QOL);IBS severity scale score(IBS-SSS);

Countries

China

Contacts

Public Contactzhangxixia

Jiangsu Provincial Hospital of Integrated Chinese and Western Medicine

543013698@qq.com13372018736

Outcome results

None listed

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