A Prospective, Single arm, Multicentric, Post-marketing Observational Study to Evaluatethe Effectiveness and Safety of Fixed Dose Combination of Mebeverine Hydrochloride135 mg and Chlordiazepoxide 5 mg Tablets in the Management ofIrritable Bowel Syndrome

Abbott India Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

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•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

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