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IRCT20191106045356N14 IRCT 2022-12-11 Islamic Azad University 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 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 2022-12-11 anticipated 70 Complete https://irct.ir/trial/65056 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This clinical trial will be conducted after considering the inclusion and exclusion criteria of the study on 70 patients aged 25 to 65 years, and the clinical diagnosis of IBS will be based on clinical evidence, colonoscopy and using IV Rome criteria by a specialist doctor. The patients will be randomly divided into two intervention groups including doxepin and memantine and the control group including doxepin and placebo randomly using the RAND function (Excel software) in one of the two divided groups (35 people in each group). The month after the start of the treatment will be followed up and the criteria of the study will be recorded. This study is a prospective and double-blind randomized controlled clinical trial and will be conducted on 70 patients who will be randomly assigned to two 35-person control or intervention groups, Randomization description: Patients were randomly assigned to variable blocks using random blocks of 4 in two groups 35 people are subjected to intervention and control. Randomization will be done using the software randomization option in Excel. accidental process Randomization is done by the study methodology consultant and the clinical researchers are not aware of the randomization process. After selecting the samples, none of the sampled people will know about randomization and the process of allocation to groups, Blinding description: To doctors table Pre-coded numbered numbers are given and the patients are included in the study in the order of the table numbers. Also, the pills are The blisters are removed and placed in a separate envelope that has a code and the pills are the same in terms of shape, color and size, so the present study is double-blind. 3 Irritable Bowel Syndrome(IBS). Intervention 1: Intervention group :patients in the first group, 25 mg of doxepin capsules daily for the first week and then 50 mg (25 mg capsules twice a day) orally for 12 weeks along with memantine 5 mg daily for the first month and then 10 mg grams orally for 12 weeks. Intervention 2: Intervention group: Patients in the second group receive 25 mg of doxepin capsules daily for the first week and then 50 mg (twice a day of 25 mg capsules) and placebo orally for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Maedeh Heydari
the second alley on the left-Khamenei 5 - Khamenei Blvd
yazd Iran (Islamic Republic of) 8915145202 +98 35 3521 1206 maedeh73heydariy@yahoo.com Islamic Azad University scientific Mohsen Zabihi
Alem sq.
Yazd Iran (Islamic Republic of) 8915145202 +98 35 3820 3865 mzabihi100@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 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. 25 years 65 years Both 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 K58.3 Irritable bowel syndrome with mixed bowel habits [IBS-M] Treatment - Drugs Treatment - Drugs Intervention group :patients in the first group, 25 mg of doxepin capsules daily for the first week and then 50 mg (25 mg capsules twice a day) orally for 12 weeks along with memantine 5 mg daily for the first month and then 10 mg grams orally for 12 weeks. Intervention group: Patients in the second group receive 25 mg of doxepin capsules daily for the first week and then 50 mg (twice a day of 25 mg capsules) and placebo orally for 12 weeks. 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). Islamic Azad University Approved 2022-10-16 Ethics Committee of Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Islamic Azad University the second alley on the left-Khamenei 5 - Khamenei Blvd Yazd Yazd Iran (Islamic Republic of)