The effectiveness of memantine in patients with Irritable Bowel Syndrome treated with doxepin in quality of life, pain and cognition of ;A double- Blinded Controlled Clinical Trial

Phase 3

Recruiting

• Conditions: Irritable Bowel Syndrome(IBS).; Irritable bowel syndrome with mixed bowel habits [IBS-M]; K58.3

• Registration Number: IRCT20191106045356N14
• Lead Sponsor: Islamic Azad University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

25-65-year-olds who have been experiencing symptoms for more than a year since the onset of symptoms and experiencing symptoms for at least three days a week
Not taking antidepressants
Not taking cardiovascular drugs
No use of corticosteroids.

Exclusion Criteria

One of the side effects of memantine is diarrhea, the prevalence of which is low, mild and transient, but if the patient does not tolerate it, the person will be excluded from the study.
History of psychotic disorders, bipolar disorders, obsessive compulsive disorders, history of moderate to severe major depression or drug abuse in the last 6 months.
Patients with suicidal thoughts and attempts.
People who are pregnant or planning to become pregnant and nursing mothers
Severe underlying disease
History of significant weight loss (5% of body weight in six months)
Gastrointestinal bleeding
Patients with cardiovascular and respiratory diseases, diabetes, hyperthyroidism
Liver disorders, seizures
Urinary retention, benign prostate enlargement
Allergy to any of the drugs used
Aggravation of the disease during the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life score in IBS-QOL questionnaire in 70 patients with irritable bowel syndrome. Timepoint: At the beginning of the study and 1, 2, and 3 months after starting to take drugs (doxepin alone or doxepin and memantine together). Method of measurement: Quality of life questionnaire for irritable bowel syndrome patients (IBS-QOL).;Pain score in questionnaire (SF-MPQ-2) in 70 patients with irritable bowel syndrome. Timepoint: At the beginning of the study and 1, 2, and 3 months after starting to take drugs (doxepin alone or doxepin and memantine together). Method of measurement: McGill Pain Questionnaire (2-SF-MPQ).;Cognitive disorders score in MMSE questionnaire in 70 patients with irritable bowel syndrome. Timepoint: At the beginning of the study and 1, 2, and 3 months after starting to take drugs (doxepin alone or doxepin and memantine together). Method of measurement: Short Mental State Test Questionnaire (MMSE).