Health Condition 1: null- Irritable Bowel Syndrome
Conditions
Interventions
Intervention1: Drotaverine Hydrochloride (80 mg): Drotaverine Hydrochloride (80 mg) three times/day one hour before principal meals for 4 weeks
Control Intervention1: Mebeverine: Mebeverine 130 mg, th
Sponsors
Walter Bushnell Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients between 18 to 80 years of either gender Fulfillment of IBS Rome III criteria Written informed consent
Exclusion criteria
Exclusion criteria: Failure to meet all inclusion criteria Pregnant females Patients with comorbid diseases, coronary artery disease (CAD), chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF) Patients taking drugs which modify or aggravate symptoms (antidepressants, calcium channel blockers etc) Patients having hypothyroidism & gluten hypersensitivity Any history of fever, passage of blood in stool, loss of weight, any organic disease of GI tract in the recent past Patients on any other concomitant medication for abdominal pain, bowel disturbance or altering gastrointestinal motility Malignancy of any other organ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in severity and frequency of abdominal pain. Global assessment by the patient and the investigator about the illness as a whole. Timepoint: week 1 week 2 week 3 week 4 one year study | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare bowel habits like character of stool, frequency and quantity of stools with drotaverine hydrochloride against mebeverine treatment. To compare reduction in bloating with drotaverine hydrochloride against mebeverine treatment. To compare assessment of Complete Smooth Bowel Movement (CSBM) with drotaverine hydrochloride against mebeverine treatment Timepoint: 0 weeks to 4 weeks | — |
Countries
India
Contacts
Public ContactDrRamesh Roop Rai
Rai Speciality care Centre
Outcome results
None listed