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IRCT20210312050678N1 IRCT 2021-03-16 Shahre-kord University of Medical Sciences Evaluation of efficacy of flaxeed oil capsule in comparison with olive oil in patients with chronic idiopathic constipation Evaluation of efficacy of flaxeed oil capsule in comparison with olive oil in patients with chronic idiopathic constipation referred to clinic and teachy hospitals of Shahrekord Univercity of Medical Sciences 2021-04-03 anticipated 105 Complete https://irct.ir/trial/54974 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into one of three groups: A (patient 1 to 35), group B (36 to 70), and group C (71 to 105), Blinding description: In the two intervention groups, drugs with similar appearance and method of use are used.The patient is explained that the herbal capsule contains olive oil or flaxseed oil.The researcher and the patient are not aware of the contents of the capsule and are distinguished by labels A and B.The Data Safety and Monitoring Committee is aware of the contents of each capsule. 2-3 Chronic idiopathic constipation. Intervention 1: Intervention group: Group A: Recipient of olive oil herbal capsules.Each capsule contains 1 gram of olive oil. It is recommended to consume 5 grams per day (two before breakfast, two before lunch and one before dinner) for two months.Barij Pharmacy Essential oil is prepared this pearl. Also, lifestyle changes are presented to the patient as a tract. Intervention 2: Intervention group: Group B: Recipient of flaxseed herbal oil capsules.Each capsule contains 1 gram of flaxseed vegetable oil. It is recommended to consume 5 grams per day (two before breakfast, two before lunch and one before dinner) for two months.Barij Pharmacy Essential oil is prepared this pearl. Also, lifestyle changes are presented to the patient as a tract. Intervention 3: Control group: Group C: Lifestyle changes.Necessary recommendations are provided to the patient in the form of tract: do not eat the main meals irregularly and eat them at a specific time. Eat breakfast within an hour after waking up, drink two glasses of warm water on an empty stomach. Consume one and a half Up to liters of water per day (6 to 8 glasses), consumption of 20 to 25 grams of fiber per day (table of high-fiber foods and the amount of fiber per unit of food is provided to patients). Yes - There is a plan to make this available What will be shared: Only part of the data such as information about the main outcome or the like can be shared. When: 2022-2023 To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: I have not decided yet Where to obtain: I have not decided yet How to obtain: I have not decided yet Comments:
public Mahnosh Salem
Parastar aven
Sahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 mahnoshsalem@gmail.com Shahre-kord University of Medical Sciences scientific Mahnosh Salem
Parastar Aven
Shahrekord Iran (Islamic Republic of) 8816754633 +98 38 3222 0016 mahnoshsalem@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients aged 25 to 70 years with a history of chronic idiopathic constipation Patients with constipation for at least 3 months and defecation up to twice a week 25 years 70 years Both K59.0 Constipation Treatment - Drugs Treatment - Drugs Lifestyle Intervention group: Group A: Recipient of olive oil herbal capsules.Each capsule contains 1 gram of olive oil. It is recommended to consume 5 grams per day (two before breakfast, two before lunch and one before dinner) for two months.Barij Pharmacy Essential oil is prepared this pearl. Also, lifestyle changes are presented to the patient as a tract. Intervention group: Group B: Recipient of flaxseed herbal oil capsules.Each capsule contains 1 gram of flaxseed vegetable oil. It is recommended to consume 5 grams per day (two before breakfast, two before lunch and one before dinner) for two months.Barij Pharmacy Essential oil is prepared this pearl. Also, lifestyle changes are presented to the patient as a tract. Control group: Group C: Lifestyle changes.Necessary recommendations are provided to the patient in the form of tract: do not eat the main meals irregularly and eat them at a specific time. Eat breakfast within an hour after waking up, drink two glasses of warm water on an empty stomach. Consume one and a half Up to liters of water per day (6 to 8 glasses), consumption of 20 to 25 grams of fiber per day (table of high-fiber foods and the amount of fiber per unit of food is provided to patients). Difficulty of defecation. Timepoint: 2 months. Method of measurement: questionnaire. Number of bowel movements. Timepoint: 2 months. Method of measurement: questionnaire. Shahre-kord University of Medical Sciences Approved 2020-10-20 Ethics Committee of Shahrekord University of Medical Sciences Parastar Aven.Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)