None listed
Conditions
Interventions
Intervention1: EVAQ Syrup: 15 ml/day for 3 days from the randomization, After day 3 dose may be incresaed to 30ml/day depending on response of the subjects (if required) upto day 9
Control Interventio
Sponsors
MEDLEY PHARMACEUTICALS LTD.
D-2,MIDC,MEDLEY HOUSE,ANDHERI (E)
MUMBAI-400093
Eligibility
Inclusion criteria
Inclusion criteria: Patients suffering from constipation (fewer than three BMs a week) for at least three months and are in need of regular laxatives such as cremaffin, liquid paraffin. Constipation as defined by the American College of Gastroenterology (ACG): Unsatisfactory defecation characterized by infrequent stools, difficult stool passage, or both. Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool, or need for manual maneuvers to pass stool. Men and non-pregnant women 18 to 60 years of age Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving any study drug. Ambulatory patients who do not require hospital admission at the time of entry into the study Patient who is able and willing to complete a daily diary card.
Exclusion criteria
Exclusion criteria: Patients suffering from hepatic encephalopathy Patients with known/suspected history of hypersensitivity to any of the trial drugs Patients with known history of colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction Patients with a known history of diabetes, hypertension, hypothyroidism, or any other metabolic disorders Patients with unknown cause of gastrointestinal bleeding, or acute infection Patients with symptoms of appendicitis or recent intestinal surgery Patients whose chronic constipation, according to the investigator's clinical judgment, is thought to be a result of: bowel surgery, gynecological surgery, neurologic disorders (e.g., aganglionosis, hypoganglionosis, autonomic neuropathy, Parkinson's disease, spinal cord injury or tumor, cerebrovascular accidents, multiple sclerosis), systemic sclerosis, myloidosis, scleroderma, myotonic dystrophy Pregnant or lactating women Patients, who within the past 30 days have participated in an investigational clinical study Drug induced constipation Patients taking prokinetic drugs e.g., Itopride, domperidone Patients taking anti-hypertensive drugs like calcium channel blockers, beta-blockers, or patients taking calcium supplements Patients with a history of drug abuse Patients with a history of any psychiatric disorders Patients with known severe renal or hepatic insufficiency, cardiac diseases Patients, who in the opinion of the investigator should not be included in the study for any reason, including inability to follow study procedures or for whom the change in prescription of laxatives is not required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of bowel movements (BM) per day Stool consistency Ease of evacuation Time taken to get first bowel evacuationTimepoint: 3,6,9 and 12 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement of the dose increment in patients Global assessment by the physician and the patient ? patients? and physicians? recorded improvement score and palatability criteria evaluated based on the visual analogue scale (VAS) by the patient. Quality of Life Questionnaire (QoL) ? PAC-QoL Timepoint: 3,6,9 and 12 days | — |
Countries
India
Contacts
Public ContactDr. Prabhakar Kolamuri
Outcome results
None listed