A Randomized Double-Blind Placebo-Controlled Trial of efficacy of phloroglucinol in Irritable Bowel Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000494

Enrollment

Registered

2012-07-27

Start date

2009-09-10

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Drug : 1)Experimental treatment:FLOSPAN TAB(phloroglucinol 80mg), 6tablets/day ,tid(ter in die), po(par os), for 2weeks 2)Placebo comparator: Placebo, 6tablets/day ,tid(ter in die), po(par os), for 2w

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The patients with diarrhea-dominant IBS (D-IBS) consented by ROME III. 2) The patients who had no organic bowel disease in the colonoscopy or Ba-enema performed within 5 years. 3) The patients who consented this trial.

Exclusion criteria

Exclusion criteria: 1) The patients who were allergic to fluoroglucin. 2) The patients who received abdominal operation except appendectomy and hernioplasty 3) The patients who have the diseases that might affect the assessment of drug efficacy, such as IBD and colon cancer. 4) The patients who take medication that might affect the assessment of drug efficacy, such as IBD and colon cancer. 5) The patients with glaucoma or prostate hypertrophy 6) The patients who have severe medical disease, such as liver cirrhosis, congestive heart failure, and chronic renal failure. 7) Prangnant or lactating patients

Design outcomes

Primary

Measure	Time frame
Subject global assessment(SGA)	—

Secondary

Measure	Time frame
visual analogue scale (VAS);Bristol Stool Scale;IBS-QOL(quality of life) questionnaire;Hospital Anxiety and Depression Scale;Adverse Drug Reactions;ADRs	—

Countries

Korea, Republic of

Contacts

Public ContactChangHwan CHOI

Chung-Ang Univerisity Hospital

Outcome results