Health Condition 1: null- Acute Idiopathic Constipation
Conditions
Interventions
Intervention1: FDC Of Ispaghula Husk IP 3.5g And Lactitol Monohydrate BP 10g Granules: Seven Days Twice A day
Control Intervention1: NIL: NIL
Sponsors
Akums Drugs Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of both sexes , aged between 18-50 years Subjects with acute idiopathic constipation(defined as presence of less than three stools per week and/or straining at stool for at least three months) who have one or more of the following symptoms associated with at least 25% of bowel movements (BMs) for at least 3 months prior to the baseline visit: very hard (little balls) and/or hard stools, a sensation of incomplete evacuation, or straining at defecation.
Exclusion criteria
Exclusion criteria: Documented mechanical obstruction, megacolon/megarectum or a diagnosis of pseudoobstruction Hypersensitivity to lactitol, Ispaghula Husk or any other constituents of the investigational product. Known or suspected organic disorders of the large or small intestine. Secondary causes of constipation. Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months before the start of the study. Prior bowel resection. Clinically significant cardiovascular, liver, lung, or other systemic disease; neurologic or psychiatric disorders. Cancer within the past 5 yr Women of childbearing potential who cannot use oral or implanted contraceptives or to have used a double-barrier method during the trial. Breast feeding women. Any other illness which could seriously effect the safety of subjects and /or the integrity of the study Subjects who, within the past 30 days have participated in an investigational clinical study. Subjects currently taking, or planning to take any of the following medications that are known to effect bowel habits: Antidiarrheals Antacids containing magnesium or aluminum salts Anticholinergics Antispasmodic agents Erythromycin and other macrolides Opiods/narcotic analgesics Prokinetics Serotonin re-uptake inhibitors or tricyclic antidepressants Calcium antagonists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Full response to treatment as a patient who has achieved type 3 to 4 category according to Bristol scale for stool passage. 2. Proportion of subjects with full response to treatment at the end of 7 days of treatment which is defined as: Full response to treatment is defined as a patient who has a SBM frequency of =3 for a given week, Spontaneous Bowel Movements (SBMs) are defined as any Bowel Movement (BM) that occurs without using rescue medication  Timepoint: 24 h after the use of rescue medication used to relieve constipation. ;Full response to treatment as a patient who has achieved type 3 to 4 category according to Bristol scale for stool passage. 2. Proportion of subjects with full response to treatment at the end of 7 days of treatment which is defined as: Full response to treatment is defined as a patient who has a SBM frequency of =3 for a given week, Spontaneous Bowel Movements (SBMs) are defined as any Bowel Movement (BM) that occurs without using rescue medication  Timepoint: 24 h after the use of rescue medication used to relieve constipation. ;To evaluate the efficacy of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation.Timepoint: day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with full response to treatment at the end of follow up phase. 2. The frequency of SBMs during 1st week of treatment; Time-to-first SBM Timepoint: proportion of subjects with a SBM within 24 and 48 h of first study drug administration;To evaluate the safety of fixed dose combination of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules in the treatment of Acute Idiopathic Constipation.Timepoint: day 7 | — |
Countries
India
Contacts
Public ContactMr R. Prasad
Nexus Clinical Research Pvt Ltd
Outcome results
None listed