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IRCT20150927024228N4 IRCT 2021-06-14 Kerman University of Medical Sciences Efficacy of traditional Persian remedy of Melissa officinalis, Rosa damascena and Pimpinella anisum in patients with irritable bowel syndrome constipation-predominant (IBS-C). Efficacy of traditional Persian remedy of Melissa officinalis, Rosa damascena and Pimpinella anisum on clinical symptoms of patients with irritable bowel syndrome constipation-predominant (IBS-C). 2021-10-07 anticipated 96 Complete https://irct.ir/trial/56072 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to block randomization, patients will be randomly entered into the study via blocks with size of 4 and 6, generated with Microsoft Excel® software. a trained secretory, who is blinded in details of the study, places patients in two groups based on these blocks, Blinding description: Drugs are packaged into two groups (A and B) by a person that won't participate in the study. Patients, researchers, physicians, and all persons that participate in collecting, and analyzing data would be blinded. After analysis, the package contents will be announced. the herbal drug and placebo are prepared in the same package in terms of color, shape, and smell in the form of 500 mg capsules. 3 Irritable Bowel Syndrome. Intervention 1: Aqueous extract of capsules of Melissa officinalis, and Pimpinella anisum; and Rosa damascene powder manufactured in the School of Pharmacy of Kerman University of Medical Sciences, two times a day, each time one 500 mg capsule, half an hour before each meal, with one glass of water, for one month. Intervention 2: Corn Starch-containing capsules, manufactured in the School of Pharmacy of Kerman University of Medical Sciences, two times a day, each time one 500 mg capsule, half an hour before each meal with one glass of water, for one month. 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 According to the partner's opinion, the final decision will be announced
public Azimi Maryam
Afzalipour hospital, Emam Khomeini highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 8000 dr.azimm@gmail.com Kerman University of Medical Sciences scientific Maryam Azimi
Afzalipour hospital, Emam Khomeini highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 8000 dr.azimm@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 18-60 years old patients with constipation-predominant irritable bowel syndrome according to Rome IV criteria. 18 years 60 years Both Pregnancy, and breastfeeding Hypothyroidism Severe complications related to this study use of other effective drugs on irritable bowel syndrome (symptoms, quality of life, anxiety, and depression) K58.9 Irritable bowel syndrome without diarrhea Treatment - Other Treatment - Other Aqueous extract of capsules of Melissa officinalis, and Pimpinella anisum; and Rosa damascene powder manufactured in the School of Pharmacy of Kerman University of Medical Sciences, two times a day, each time one 500 mg capsule, half an hour before each meal, with one glass of water, for one month Corn Starch-containing capsules, manufactured in the School of Pharmacy of Kerman University of Medical Sciences, two times a day, each time one 500 mg capsule, half an hour before each meal with one glass of water, for one month IBS symptom severity score. Timepoint: At the beginning of the intervention, after 4 weeks. Method of measurement: IBS symptom severity score questionnaire. Quality of life of IBS patients. Timepoint: At the beginning of the intervention, after 4 weeks. Method of measurement: Quality of life questionnaire of IBS patients. Anxiety and depression. Timepoint: At the beginning of the intervention, after 4 weeks. Method of measurement: Anxiety and depression questionnaire. Kerman University of Medical Sciences Approved 2019-05-06 Ethics Committe of Kerman University of Medical Sciences Afzalipour hospital, Emam Khomeini highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)