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IRCT20160813029327N20 IRCT 2022-04-26 Islamic Azad University Studying the effect of Fexofenadine on patients with irritable bowel syndrome Evaluation of the efficacy of Fexofenadine in combination with Mebeverine and Mebeverine with placebo in patients with irritable bowel syndrome 2022-04-09 anticipated 60 Complete https://irct.ir/trial/48818 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random number table: Two groups of 30 patients were made using simple randomization method, based on Random Sequence Generator via www.random.org website. For Random Allocation concealment, the method of opaque sealed envelopes with random sequence was used. Patients were allocated in one of two groups based on their entry sequence, Blinding description: In this study both researcher and patients are not aware which medication the patient is using. Drugs will be dispensed by researcher in uniform packages with codes. Placebo tablets are quite similar in color and shape to the drug. 3 Irritable bowel syndrome. Intervention 1: Intervention group: In this group, patients will receive Foxofenadine 180 mg tablets produced by Exir Pharmaceutical Company once a day for 4 weeks plus their standard treatment, which is Mebeverine 200 mg capsules produced by Actover Pharmaceutical Company once a day. Intervention 2: Control group: In this group, patients will receive Placebo tablets produced by Exir Pharmaceutical Company once a day for 4 weeks plus their standard treatment, which is Mebeverine 200 mg capsules produced by Actover Pharmaceutical Company once a day. Yes - There is a plan to make this available What will be shared: Information about the primary outcome will be shared after Deidentification of Individual Participant Data When: after publication of paper,for two years To whom: Academic persons Conditions: Academic or clinical use. users should cite the primary document Where to obtain: via email to corresponding author How to obtain: Submition of valid and formal documentation of affiliation to the Academic Center, Explaination about how to use the information and the purpose of request Comments:
public Ramin Abrishami
Shariati Ave, Yakhchal Street, Tehran.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 1889 r_abrishami@iaups.ac.ir Islamic Azad University scientific Ramin Abrishami
Shariati Ave, Yakhchal Street, Tehran.
Tehran Iran (Islamic Republic of) 1941933111 +98 21 2264 1889 r_abrishami@iaups.ac.ir Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with irritable bowel syndrome based on Rome IV criteria Age between 18-65 years old Informed consent 18 years 65 years Both Patients with diabetes, cardiovascular diseases, neurological and psychiatric disorders, hepatic disorders, renal failure, Celiac and colitis Pregnancy and lactation History of drug allergy K58 Irritable bowel syndrome Treatment - Drugs Placebo Intervention group: In this group, patients will receive Foxofenadine 180 mg tablets produced by Exir Pharmaceutical Company once a day for 4 weeks plus their standard treatment, which is Mebeverine 200 mg capsules produced by Actover Pharmaceutical Company once a day. Control group: In this group, patients will receive Placebo tablets produced by Exir Pharmaceutical Company once a day for 4 weeks plus their standard treatment, which is Mebeverine 200 mg capsules produced by Actover Pharmaceutical Company once a day. Abdominal Pain (Severity of pain and Duration of pain). Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS). Abdominal distension (Bloating, Swollen or Tight tummy). Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS). Satisfaction with fecal excretion. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS). The impact of the IBS on the Patient's Quality of Life. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS). Irritable Bowel Syndrome Severity Score. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Irritable Bowel Severity Scale (IBSS). Islamic Azad University Approved 2019-05-06 Ethics committee of Islamic Azad University of Tehran Medical Science No. 99, The First of Yakhchal Ave., Gholhak, Shariati St. Tehran Tehran Iran (Islamic Republic of)