]>
IRCT20180519039707N1 IRCT 2018-12-01 Kerman University of Medical Sciences Comparison of efficacy of Traditional Medicine ( Zataria multiflora Boiss. and Trachyspermum Copticum (L.) Link) on Clinical symptom in patient with Irritable bowel syndrome (IBS) Comparison of efficacy of two traditional medicine, Zataria multiflora Boiss and trachyspermum Copticum (L.) Link, on Clinical symptom in patient with Irritable bowel syndrome (IBS) 2018-09-06 anticipated 150 Complete https://irct.ir/trial/32773 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple Randomization is done. The first patient receives drug A; The second patient receives drug B and the third patient receives drug C. This cycle is repeated, Blinding description: The medicine is prepared and coded by a third person at the Faculty of Pharmacy in Kerman University of Medical Sciences. Then it is presented to the researcher and the researcher gives it to the patient. The patient and the researcher are not informed (blind) about the drug. The drug results will be decoded after extracting of the results. 3 Irritable bowel syndrome. Intervention 1: Intervention group 1: consuming 750 mg capsule (Zataria multiflora Boiss and Trachyspermum Copticum (L.) Link), BID( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention. Intervention 2: Placebo group: consuming 750 mg capsule (Corn starch), BID ( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention. Intervention 3: Intervention group 2: 133 mg capsule( Mebeverine ), BID( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention. Yes - There is a plan to make this available What will be shared: After the study, information on the main outcome will be shared When: starting 9 months after publication To whom: All researchers can apply to receive it. Conditions: Data and results will be available to all researchers in order to continue the research and implementation of the irritable bowel after the publishing of results. Where to obtain: email addresses: hjamalizadeh_14@yahoo.com How to obtain: after checking Confirmation of demandو file(s) will be offered during 1 weak Comments:
public Hossein Jamalizadeh Tajabadi
Jahad Avenue, Besat Clinic
Kerman Iran (Islamic Republic of) 7619837773 +98 34 3226 8622 hjamalizadeh_14@yahoo.com Kerman University of Medical Sciences scientific Hossein Jamalizadeh Tajabadi
Besat Clinic, Jahad Avenue
Kerman Iran (Islamic Republic of) 7619837773 +98 34 3226 8622 hjamalizadeh_14@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) fulfilling Rome III criteria for IBS Completion of the consent form Being at the age of 18 to 60 years old 18 years 60 years Both Pregnancy Breast feeding History of gastrointestinal surgery Any serious drug-related inverse effect Inevitable weight loss History of any diseases like Crohn's disease and ulcerative colitis Dyspepsia Severe mental retardation Any kind of substance abuse or alcohol consumption Not completing the consent form The occurrence of warning signs (weight loss, anemia, Hematochezia or melena, dysphagia) K58 Irritable bowel syndrome Treatment - Drugs Placebo Treatment - Drugs Intervention group 1: consuming 750 mg capsule (Zataria multiflora Boiss and Trachyspermum Copticum (L.) Link), BID( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention. Placebo group: consuming 750 mg capsule (Corn starch), BID ( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention. Intervention group 2: 133 mg capsule( Mebeverine ), BID( in the morning and in the evening before meals) for 4 weeks. The response to the treatment, quality of life and the severity of symptoms are checked in each patient. This response is investigated using questionnaire before and 4 and 6 weeks after intervention. Quality of Life (QOL). Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention). Method of measurement: The quality of life questionnaire (IBS-QOL-34). Pain. Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention). Method of measurement: Visual Analogue Scale. Flatulence. Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention). Method of measurement: Visual Analogue Scale. Constipation. Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention). Method of measurement: Visual Analogue Scale. Diarrhea. Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention). Method of measurement: Visual Analogue Scale. Difficulty in bowel movements. Timepoint: before the intervention, after 4 weeks, after 6 weeks (2 weeks after the interrupting the intervention). Method of measurement: Visual Analogue Scale. Kerman University of Medical Sciences Approved 2018-09-14 Ethics committee of Kerman University of Medical Siences Besat Clinic, Jahad Street Kerman Kerman Iran (Islamic Republic of)