Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: Fixed-dose oral formulation containing the milk of magnesia, liquid paraffin, and sodium picosulphate: In this PMOS, post-ano-rectal surgical patients with symptoms of constipation will
Sponsors
Abbott India Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Post-ano-rectal surgery (anal fissures, anal fistulas, and hemorrhoids) patients of either sex, in the age group of =18 and =65 years. 2. Patients having symptoms of constipation for a minimum of 3 days before the day of surgery. 3. Women of childbearing potential who had a negative pregnancy test were non-lactating and were willing to use adequate throughout the study. 4. Patients willing to comply with study procedures and requirements. 5. Patients who understood the requirements of the study and were willing to sign and date the informed consent form before participating in the study.
Exclusion criteria
Exclusion criteria: 1. Patients with a history/ongoing congestive heart failure, severe hepatic or renal dysfunction, or neurological conditions (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy). 2. Pregnant or lactating women. 3. Patients with ingestion of laxatives or any drug affecting GI motility in the last 3 days or known hypersensitivity, as per the discretion of the investigator at screening. 4. Patients not willing to provide written informed consent to be excluded. 5. Patients with ongoing intestinal obstruction, ileus, toxic megacolon gastric retention abdominal pain, nausea or vomiting, ongoing irritable bowel syndrome (IBS) with constipation at screening. 6. Patients with history/ongoing psychiatric conditions. 7. Patients with active or cured malignancies. 8. Patients with a history of hypersensitivity to liquid paraffin, magnesium hydroxide, or sodium picosulfate. 9. Patients with any medical condition judged by investigators that warrant exclusion at screening. 10. Patients who have been on any laxatives containing, Milk of Magnesia, Liquid paraffin, and Sodium Picosulfate in the last 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To determine the effectiveness of fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in the treatment of constipation symptoms in post-ano-rectal surgical patients.Timepoint: Day 0, 4 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the treatment response in terms of bowel symptom relief after 4±2: days and 15-day treatment with fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion in post-ano-rectal surgical patients. 2. To determine the impact of treatment with the fixed-dose formulation of milk of magnesia, liquid paraffin, and sodium picosulphate oral emulsion on the quality of life (QoL) of patients using the Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL).Timepoint: Day 0, 4 and 14 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott India Limited
Outcome results
None listed