Evaluation of the curative effect of berberine on patients with irritable bowel syndrome complicated with depression

A multicenter randomized controlled single-blind clinical study of berberine on the clinical symptoms and intestinal flora of patients with irritable bowel syndrome complicated with depression

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049397

Enrollment

Unknown

Registered

2021-08-02

Start date

2021-07-31

Completion date

Unknown

Last updated

2023-07-10

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

Conditions

irritable bowel disease with depression

Interventions

Berberine group:Berberine 300mg, 3 times a day

Placebo group:Placebo (300mg berberine dosage form placebo, 3 times/day)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18 to 65 years; 2.There is no abnormality in blood routine, blood biochemistry and routine examination of stool; 3.The patient informed consent to the study; 4.Recurrent abdominal pain that meets the diagnostic criteria of IBS-D Rome IV, which occurred at least 1 day a week in the past 3 months, and was accompanied by two or more of the following: episodes related to defecation accompanied by changes in frequency of defecation accompanied by changes in fecal properties; 5.Meet the diagnostic criteria of depression according to Hamilton Depression (HAMD) score,>=8 points.

Exclusion criteria

Exclusion criteria: 1.Suffering from the excessive proliferation of small intestinal bacteria (screening by hydrogen-methane breath test) and organic diseases such as gastrointestinal tumors; 2.Combined with serious heart, liver, lung, kidney, blood, endocrine, and nervous system diseases and Autoimmune diseases; 3.Severe depressive state: Hamilton HAMD score>35 points; 4.Multiple peripheral vascular diseases; 5.Infection of respiratory tract, digestive tract, urinary tract and other parts; 6.A history of abdominal surgery other than appendicitis; 7.Suffer from other gastrointestinal diseases that can explain clinical symptoms; 8.Antibiotics and systemic hormones have been used in the past month; 9.Consecutive use of intestinal microecological preparations, laxatives, and antidiarrheal drugs for more than 3 days in the past 2 weeks; 10.Pregnant and lactating women; 11.Patients with severe mental disorders, such as schizophrenia, manic depression, etc.

Design outcomes

Primary

Measure	Time frame
Symptoms improved in patients with irritable bowel syndrome;Overall gastrointestinal symptoms improved;Depressive symptoms improved;	—

Secondary

Measure	Time frame
Visceral sensitivity;Changes in fecal flora;Microbial metabolites;Peripheral inflammatory factors and neurotransmitters;Metabolic changes;	—

Countries

China

Contacts

Public ContactDuan Liping

Peking University Third Hospital

602458052@qq.com+86 13901009183

Outcome results

None listed

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