A multicenter, Randomized, Controlled, Double-Blind and Double-Simulated Study to Evaluate the Efficacy and Safety of the treatment based on syndrome differentiation of Irritable Bowel Syndrome with diarrhea

A study on the clinical demonstration of treating Irritable Bowel Syndrome with diarrhea

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13004553

Enrollment

Unknown

Registered

2013-11-10

Start date

2014-03-01

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

Irritable bowel syndrome with diarrhea (IBS-D)

Interventions

Experimental group:Treatment based on syndrome differentiation of traditional Chinese Medicine(Chinese medicine granule)

Control group 1:Chinese medicine granule of placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of IBS-D of Rome III criteria; (2) Aged between 18 years to 70 years; (3) The score of IBS-SSS more than 75; (4) Sign the informed consent and will to accept corresponding intervention; (5) Live locally for a long time which can be treated and followed-up, have the ability of reading.

Exclusion criteria

Exclusion criteria: (1) IBS-C, IBS-M and unsubtyped IBS; (2) Patients accompanied with serious diseases of heart, liver,kidney, hematopoietic systems, etc, or patients with tutor; (3) Patients with structural abnormity of digestive system or systematic disease which can affect bower movements of gastrointestinal tract (such as hyperthyreosis, diabetes, chronic renal insufficiency, psychiatric or nervous system disease); (4) Patients who are in use or will continue to take drugs which may affect function of gastrointestinal tract(such as anticholinergic agents, Ca2+ channel blocker, 5-HT3 receptor antagonist, antidiarrheal, antiacid, prokinetics, antidepressant drug; ntianxietic, microecological modulator of intestinal flora); (5) History of operation on abdominal region, such as ecphyadectomy and cholecystectomy; (6) History of allergy to food and drugs; (7) Pregnant or lactating females; (8) History of psychiatric or nervous system disease; (9) Patients who are in other clinical trials.

Design outcomes

Primary

Measure	Time frame
IBS-SSS;	—

Secondary

Measure	Time frame
global assessment scales;IBS-QOL;PRO;Improvement of the syndromes of Traditional Chinese Medicine;	—

Countries

China

Contacts

Public ContactXudong Tang

Xiyuan Hospital of China Academy of traditional Chinese Medicine

txdly@sina.com+86 13901137632

Outcome results

None listed

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