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IRCT20200108046056N1 IRCT 2020-02-25 Kerman University of Medical Sciences Traditional remedy of Foeniculum vulgare and Rosa Damascena on clinical symptoms of elderly patients with constipation The Comparison of the effects of traditional remedy of Foeniculum vulgare and Rosa Damascena on clinical symptoms of elderly patients with functional constipation 2020-02-20 anticipated 60 Complete https://irct.ir/trial/44926 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 people aged 60 years Community Health Centers who suffer from constipation each person has a proprietary code given by A statistic consultant is provided in blocks 4 and unaware of which code belongs to which group is placed in the envelope (with random allocation based on the referral of patients) and the subjects are randomly assigned to two groups of control and intervention. Questionnaires are completed before and after the intervention by a researcher who is unaware of the intervention and control group. Constipation is the main variable in this studyp also performs the usual treatment, Blinding description: This study is a double blind study. Medicines are manufactured by a traditional pharmacist and packaged and coded uniformly. The person doing the coding has no role in the study until the end of the intervention. Patients are randomly assigned to one of the two study groups by a person who has no knowledge of how the drugs are coded. Statistical analysis of the study is performed by a third person who is unaware of how the groups are coded. 3 constipation. Intervention 1: Intervention group: Patients with chronic constipation treated with sachet of Roses Damascena and Foeniculum vulgare which was produced at the Kereman university of Medical Science, faculty of Persian medicine, as a sachet and dosed with the desired dosage . 10 grams of sachets (containing 5 grams of Foeniculum vulgare powder and 5 grams of Rosa domascena powder), two times a day, in the morning and evening before meals and mix with a glass of warm water. Intervention 2: Control group: 10 gr sachet of PEG powder, two times a day, in the morning and evening before meal, with one glass of warm water. Yes - There is a plan to make this available What will be shared: Only, information about the outcome of the study will be published. When: The publication time after the publication of the results will be in a journal. To whom: Anyone who wants to have access to information after publishing in a journal. Conditions: Analysis of data based on statistical software. Where to obtain: Kerman University of Medical Sciences.After publication in a journal can go to the website of the journal. Refer to this email:s_khodabandeh@kmu.ac.ir How to obtain: After the publication of the study information in a journal, it can immediately access the information. Comments:
public Sedigh Khodabandeh Shahrki
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5219 S_khodabandeh@kmu.ac.ir Kerman University of Medical Sciences scientific Maryam Azimi
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7618843883 +98 34 3211 0119 dr.azimm@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) The elderly over 60 years of age mentally alert and able to answer questions constipation approved in accordance with Rome IV diagnostic criteria. informed consent. Having informed consent no history of gastrointestinal obstructive disorders. No history of gastrointestinal inflammatory diseases. 60 years no limit Both unwillingness to continue participation in the study at any time of the study. The occurrence of acute complications during the intervention. use of laxatives for constipation during the study. Reporting any signs suggesting an allergic reaction to Foeniculum vulgare and Rosa Damascena. Not taking regular medication K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: Patients with chronic constipation treated with sachet of Roses Damascena and Foeniculum vulgare which was produced at the Kereman university of Medical Science, faculty of Persian medicine, as a sachet and dosed with the desired dosage . 10 grams of sachets (containing 5 grams of Foeniculum vulgare powder and 5 grams of Rosa domascena powder), two times a day, in the morning and evening before meals and mix with a glass of warm water. Control group: 10 gr sachet of PEG powder, two times a day, in the morning and evening before meal, with one glass of warm water People with constipation who have 2 or more grade according to Rome 4 criteria. Timepoint: All of the above groups meet weekly on a weekly basis: initial visit and diagnosis before the intervention, one month after intervention and two month after the intervention intervention. Method of measurement: Questionnaire based on the international diagnostic criteria of chronic constipation-ROMIV. Quality Of Life. Timepoint: Before the intervention. one month after intervantion, two month after the interventionintervention. Method of measurement: Patient Assessment of Constipation Quality of Life Questionnaire. Kerman University of Medical Sciences Approved 2020-01-13 Ethics committee of Kerman University of Medical Sciences and Health Services Jahad Blvd. Ebn Sina Avenue, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)