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Study on the therapeutic mechanism of traditional Chinese medicine in the treatment of irritable bowel syndrome based on intestinal micro ecology

Study on the therapeutic mechanism of traditional Chinese medicine in the treatment of irritable bowel syndrome based on intestinal micro ecology

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16010192
Enrollment
Unknown
Registered
2016-12-20
Start date
2016-12-21
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

irritable bowel syndrome

Interventions

Traditional Chinese medicine group:take NO.1 Granules
placebo group:take placebo
Health control:nothing

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine;International Institute of Translation Chinese Medicine,Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: To simultaneously satisfy the following criteria: (1) Conform to the Roman IV(Rome IV) of a patient diagnosed with IBS-D; (2) Aged 20 to 50 years, gender not limited, born in south of the Five Ridges; (3) Nearly 1 weeks no using the drug in the treatment of IBS; (4) Nearly 2 weeks no using antibiotics or probiotics; (5) Be voluntary to drug treatment, and signed informed consent, the informed consent process in conformity with the relevant provisions of the GCP.

Exclusion criteria

Exclusion criteria: Meet one of the following criteria were excluded: 1. there is explanation above the clinical symptoms of the patients with other diseases; 2. chronic esophagitis, Barrett esophagus and gastroesophageal reflux disease, peptic ulcer, gastric polyp (without resection), digestive tract tumor patients; 3. found that endoscopic gastric mucosa high grade intraepithelial neoplasia, pathological diagnosis, malignant gastrointestinal organic diseases; 4. patients with history of abdominal operation; 5. allergic or allergic to many medicines; 6. confusion, dementia, psychosis, neurosis and various serious unwilling to cooperate; 7. with serious the primary cardiovascular disease, liver disease, kidney disease, blood disease, lung disease, autoimmune diseases, or serious diseases affected the survival, such as cancer or aids; 8. pregnant and lactating women; 9. exist cognitive or other damage (such as vision, etc.) and impact on the participants completed self-report; 10. of the pharmaceutical composition ingredients allergies are; is or 4 weeks in other drug clinical trials of patients; 11. investigators have sufficient reason to believe that the participants according to current medical or psychological state is not suitable for researchers to study.

Design outcomes

Primary

MeasureTime frame
intestinal flora;

Secondary

MeasureTime frame
IBS-SSS;IBS-QOL;HAD;CRO;SSDPRO-IBS;5-hydroxytryptamine;

Countries

China

Contacts

Public ContactLIU Feng-bin

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

liufb163@163.com+86 18902296111

Outcome results

None listed

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