chronic constipation. Constipation
Conditions
Interventions
Intervention 1: In this study, a group of patients with chronic constipation will be treated with magnesium oxide. Magnesium oxide is a laxative that works by drawing water into the colon, which helps
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients aged 18 years and older. Patients diagnosed with chronic constipation based on Rome IV criteria. Patients must have visited Loghman Hakim Hospital for the treatment of chronic constipation. Patients must be willing to participate in the study and provide informed consent. Patients must not have received treatment for chronic constipation in the 30 days prior to study enrollment.
Exclusion criteria
Exclusion criteria: Individuals who experience severe side effects or unwanted changes in their health status during the study. Individuals who voluntarily withdraw or refuse to continue their participation or follow-up during the study. Individuals who, for medical reasons, are unable to continue treatment or intervention (e.g., diagnosis of a new disease or deterioration of health condition). Individuals who fail to provide necessary follow-up or data during the study. Individuals who develop unforeseen cognitive or physical disabilities during the study. Participants for whom, according to the investigator's opinion, continuing participation in the study would be harmful.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is the frequency of bowel movements, assessed by the number of bowel movements per week. Additionally, stool consistency will be evaluated using the Bristol Stool Scale, and constipation severity will be measured using the Constipation Severity Index based on patient-reported symptoms. Timepoint: The primary outcomes will be measured at 28 days after the initiation of the treatment (Magnesium Oxide or Senna). Method of measurement: The primary outcome (chronic constipation) will be measured using the Bristol Stool Scale to assess stool consistency and frequency. Additionally, patients will be asked to complete the Constipation Severity Index (CSI), a validated questionnaire, to evaluate the severity of their symptoms. These assessments will be performed at baseline and on day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary outcome variable of this study is adverse drug reactions, which includes any negative reactions resulting from the use of magnesium oxide and senna. These may include diarrhea, abdominal pain, nausea, cramps, bloating, or other gastrointestinal or general side effects. Patients will report daily, and all adverse reactions will be carefully documented and monitored. Timepoint: This outcome will be measured at 28 days after the initiation of the treatment (Magnesium Oxide or Senna). Method of measurement: Adverse drug reactions are collected through patient interviews and clinical examinations. During follow-up sessions, the patient reports any adverse effects or negative reactions to the medication. The treating physician evaluates the type and severity of the reactions clinically and records them in the designated forms.;Quality of life of patients is assessed using the WHOQOL-BREF questionnaire. This questionnaire consists of 26 questions that evaluate the patient's overall health, physical, psychological, social, and environmental well-being. The results are analyzed based on the overall scores and subscale scores in different domains of quality of life. Timepoint: This outcome will be measured at 28 days after the initiation of the treatment (Magnesium Oxide or Senna). Method of measurement: Quality of life is measured using the WHOQOL-BREF questionnaire. This questionnaire consists of 26 questions that assess the individual's quality of life in four main domains: physical health, psychological health, social relationships, and environmental conditions. Responses are recorded on a 5-point Likert scale (from strongly disagree to strongly agree), and overall scores as well as domain-specific scores are calculated. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShahriar Nikpour
Shahid Beheshti University of Medical Sciences
Outcome results
None listed