A Randomized, Double-Blind, Placebo-Controlled Trial of Tongxiening for The Treatment of Irritable Bowel Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15006415

Enrollment

Unknown

Registered

2015-05-15

Start date

2015-06-05

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

IBS-D

Interventions

control group:placebo

treatment group:Tongxiening

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who met the Rome III criteria for IBS-D; 2. IBS-SSS > 75; 3. aged 18-65 years; 4. Patients who provided consent were eligible if they did not meet any exclusion criteria.

Exclusion criteria

Exclusion criteria: 1. Diarrhea that due to infectious, inflammatory bowel disease, malabsorption syndrome, hyperthyroidism, systemic disease, poisoning, parasitic infections and cancer; 2. IBS with constipation , mixed IBS and uncertain IBS; 3. Digestive organic disease (such as chronic pancreatitis, etc.), or systemic diseases affecting gastrointestinal motility (such as hyperthyroidism, diabetes, chronic renal failure, neuropsychiatric disease, etc.); 4. Patients who is taking medicines that may affect gastrointestinal motility (such as anticholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, intestinal flora regulating drugs) recently or all the time; 5. Patients who had been taken abdominal surgery (such as cholecystectomy, etc.); 6. Patients who had taken medicines for the treatment of IBS for the recent 2 weeks; 7. Pregnancy or breast-feeding women; 8. Patients with severe heart, brain, liver, kidney, endocrine, blood and other systemic diseases, including blood ALT, AST more than the limitation of 1.5 times or Cr more than the limitation of 1.2 times; 9. Allergy for the medicine; 10. Patients with disabilities (blind, deaf, dumb, mental retardation, mental disorders, etc.); 11. Patients who had taken part in other trials for the recent 3 months.

Design outcomes

Primary

Measure	Time frame
IBS-SSS;AR;	—

Secondary

Measure	Time frame
IBS-QOL;defecation;Improvement of anxiety and depression;	—

Countries

China

Contacts

Public ContactZhenghua Li

lindberg_li@163.com+86 13671157196

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026