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A multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Changanyihao Decoction in Patients of Irritable Bowel Syndrome with diarrhea

Clinical research of IBS-D by TCM treatment with the collaboration of China and Germany

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-09000328
Enrollment
Unknown
Registered
2009-02-15
Start date
2009-03-01
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

Control group:Decoction of placebo, 150ml, Tid
Experimental group:Changanyihao Decoction, 150ml,Tid

Sponsors

Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Fulfill the diagnostic criteria of IBS-D of Rome III criteria; (2) 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 some time which can maintain treatment and follow-up, have the ability of reading power.

Exclusion criteria

Exclusion criteria: (1) IBS-C, IBS-M and unsubtyped IBS; (2) Patients accompanied with serious disease of heart, liver, hematopoietic system, 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

MeasureTime frame
the character of stool;Adequate relief, AR;IBS-SSS;

Secondary

MeasureTime frame
HAD;IBS-QOL;Improvement of syndromes of Traditional Chinese medicine;

Countries

China

Contacts

Public ContactXudong Tang
txdly@sina.com+86 010 62835001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026