A scientific Study to understand the effect ofMebeverine Hydrochloride 135 mg and Chlordiazepoxide 5 mg Tablets in Indian Patientwith Management of Irritable Bowel Syndrome
- Conditions
- Health Condition 1: K589- Irritable bowel syndrome without diarrhea
- Registration Number
- CTRI/2020/09/027980
- Lead Sponsor
- Abbott India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Male and female patients above 18 up to 60 years
Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigatorâ??s discretion, throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at baseline
Patients who are newly diagnosed with IBS along with anxiety and are recommended the study drug as per investigator discretion
Patient willing to sign Patient Authorization Form (PAF)
Hypersensitivity to the active substances or any of the study drug excipients
Severe respiratory insufficiency, organic brain damage, sleep apnea syndrome, severe, acute or chronic hepatic insufficiency (risk of occurrence of encephalopathy), myasthenia gravis, chronic psychosis, major depressive episodes, phobic or obsessional states, or dementia
Other preexisting GI disorders, patients with history of GI surgery, abnormal upper, and lower GI endoscopy finding
Family history of colon cancer or inflammatory bowel disease
Patients with alarm symptoms (red flag or the symptoms that discriminates lower GI organic diseases from IBS) (Hammer et al 2004); e.g.,
a.Blood in stool
b.Nighttime symptoms that wakes a person
c.Unintentional weight loss
d.Change in typical IBS symptoms will be noted. E.g. new and/or different pain
History of chronic alcoholism or other drug related dependency
History of excessive alcohol intake (women: >=8 drinks per week; men: >=15 drinks per week)a
History of addiction to narcotics
Patient who excessively drives or operate hazardous machinery
Any past or present conditions or diseases that investigator considers not appropriate to enter the study
Current use or past history of any medication in last 3 months which might interfere with the action of the study drug
Pregnant and lactating women
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is change in mean IBS SSS total scoreTimepoint: from baseline to week 8.
- Secondary Outcome Measures
Name Time Method