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IRCT20160306026938N14 IRCT 2022-10-18 Tehran University of Medical Sciences The effect of fig fruit and kiwi extract on constipation. Evaluation of the effectiveness of syrup containing extract of Fucus carica and Actinidia deliciosa in patients with constipation 2022-11-06 anticipated 70 Complete https://irct.ir/trial/65913 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 70 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 35 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 70, Blinding description: In this study, only the participants were not informed about receiving either treatment/placebo capsules. Thus, the study is a single-blinded one. The subjects in this study were not either relatives or friends, thus they couldn't compare the impacts of receiving placebo/treatment. In addition, the appearance of the syrups and their containing package was exactly similar in both Intervention/control group and is not differentiated. All the study subjects received a good deal of information regarding the research plan and have been presented to them .After being randomized through the use of statistical software package, treatment/placebo has been provided for them. 2 Constipation. Intervention 1: Intervention group: Oral prescription of a syrup containing extract of fig fruit and kiwi, made in Pharmacognosy laboratory of Tehran's University of Medical Science, administered on 35 Constipation patients, two times a day (morning-evening), for a one-month period. Intervention 2: Control group: Oral prescription of a Lactulose syrup administered on 35 Constipation patients, two times a day (morning-evening), for a one month period. Yes - There is a plan to make this available What will be shared: Demographic specification of patients, would be published, except their names and address. Primary outcome of the patients would be published, too. When: Data would be available 6 months after publishing the results. To whom: .Data would be available for researchers in academic and scientific organisations. Conditions: Any type of usage of data is allowable, except using for manufacturing a product. Where to obtain: Sending an E. mail to mehdivazirian@gmail.com How to obtain: After receiving E. mail, data would be sent within a week. Comments:
public Mahdi Vazirian
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6412 1223 Vazirian_m@tums.ac.ir Tehran University of Medical Sciences scientific Mahdi Vazirian
Pharmacognosy Lab., Second Floor, New buliding, Faculty of Pharmacy, In front of Oruji Alley, 16th Azar Ave., Enqelab Ave.
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6412 1223 Vazirian_m@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Being afflicted with constipation Age range of 18-70 years old Signing the informed consent 18 years 70 years Both Being afflicted with any underlying disease Pregnancy Being allergic to fig and kiwi. Lactation periode Consumption of medications for improvement of constipation K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: Oral prescription of a syrup containing extract of fig fruit and kiwi, made in Pharmacognosy laboratory of Tehran's University of Medical Science, administered on 35 Constipation patients, two times a day (morning-evening), for a one-month period. Control group: Oral prescription of a Lactulose syrup administered on 35 Constipation patients, two times a day (morning-evening), for a one month period. Constipation. Timepoint: After intervention. Method of measurement: Scoring patients based on a 0-10 Likert Scale with regard to improvements in symptoms(0=no improvement; 10= complete improvement). Tehran University of Medical Sciences Approved 2022-09-04 Research Ethichs Committees of The Institute of Pharmaceutical Sciences- Tehran University Of Medica 16 Azar Avenue, Tehran University of Medical Sciences, Faculty of Pharmacy, The Institute of Pharmaceutical Sciences, 2nd floor, Unit 1-219. Tehran Tehran Iran (Islamic Republic of)