Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: liquid paraffin, milk of magnesia and sodium Picosulphate
: 5ml liquid paraffin 1.25ml I.P, milk of magnesia 3.75 ml I.P, sodium Picosulphate B.P 3.33Mg
Duration- 8weeks
frequency & Do
Sponsors
Dr Nitesh Pratap
Eligibility
Inclusion criteria
Inclusion criteria: 1) Adult male or non-pregnant female patients aged 18-65 years (both inclusive) who are prescribed Combination of Milk of Magnesia, Liquid Paraffin, and Sodium Picosulfate oral emulsion for the treatment of chronic constipation associated with the following comorbidities,T2DM and/or hypothyroidism and/or hypertension 2) Diagnosed cases of comorbid conditions: T2DM and/or hypertension and/or hypothyroidism (as per physician discretion)and suffering from underlying chronic constipation(patient having test report of the last 6 months) 3) Patients who are willing to give informed consent for participating in the study.
Exclusion criteria
Exclusion criteria: Patients must not meet any of the following exclusion criteria to be eligible for enrollment in the study 1) Patients who have received any pharmacotherapy containing Milk of Magnesia or Liquid Paraffin or Sodium Picosulfate for chronic constipation within 2 weeks before enrollment 2) Patients with ingestion of any drug affecting GI motility or known hypersensitivity 3) Patients with organic bowel disease, GI obstruction/perforation, history of GI surgery, and painful abdominal symptoms where the cause is uncertain 4) Patients with severe hepatic or renal dysfunction 5) Patients suffering with psychiatric conditions 6) Patients with active or cured malignancies 7) Patients with any medical condition judged by investigators that warrant exclusion 8) Pregnant and/or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Change in mean total Patient Assessment of Constipation Symptoms (PAC-SYM) scale score. 2) Change in mean spontaneous bowel movements per week. Timepoint: From Baseline at week 4 and week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in mean Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) score 2) Number & percentage of patients with ADRsTimepoint: At Baseline, week 4 & week 8 | — |
Countries
India
Contacts
Public ContactDr Nitesh Pratap
Krishna institute of Medical sciences
Outcome results
None listed