]>
IRCT20200714048108N1 IRCT 2020-09-19 Tabriz University of Medical Sciences Effect of Ficus carica and Juglans regia product on the treatment of functional Constipation of older Adults Evaluation of the effect of Ficus carica and Juglans regia product on the treatment of functional Constipation of older Adults: A double blind randomized clinical trial 2020-09-05 anticipated 90 Complete https://irct.ir/trial/50369 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another researcher will measure the patients outcome and he will not know the allocation, Blinding description: The Gastroenterologist will be aware of the research topic and will perform therapeutic interventions. He codes the patients and refers them to a his colleague to check the patient's stomachs and record the relevant criteria based on the same code. The patients will be tested in the same condition and given the same syrup (Syrups that are the same in color, smell and appearance), but they will not be aware from the type of medicine. Accordingly, this study will be a double-blind study. N/A Constipation. Intervention 1: Intervention group: For each patient is given 15 cc of fig and walnut syrup one hour before bedtime for two consecutive weeks. Intervention 2: Control group: For the control group, each patient is given 15 cc of lactulose syrup (as a remedy for constipation) one hour before bedtime for two consecutive weeks. Yes - There is a plan to make this available What will be shared: Participant Data File: Because the individual data of the study participants are considered, this study shares some of the data such as information about the main outcomes of the study. When: The access period starts 10 months after the results are published. To whom: The data obtained from this study are only available to researchers working at Tabriz University of Medical Sciences. Conditions: The data of this research are only permitted for review and meta-analysis studies. Where to obtain: Visit Mr. Saeed Jodi from Tabriz University of medical science, or contact him by email or phone. Phone: 09143081743, Email: saeedjodi1348@gmail.com How to obtain: Applicants are required to submit a written request to Mr. Jodi by email (10 months after the publication of the research results). After reviewing the request, the data will be sent to the applicant online via email. Comments:
public Saeed Jodi Khajeh
University Street, 3rd Floor, Central Building, Tabriz University of Medical Sciences, Iran
Tabriz Iran (Islamic Republic of) 5166614766 +98 914 308 1743 saeedjodi1348@gmail.com Tabriz University of Medical Sciences scientific Dr Mostafa Araj khodaei
University Street, Tabriz University of Medical Sciences, Iran
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3335 7310 mostafaa33@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Forcing in more than more than 3 times a week Hard or bullet-like stools in more than 3 times a week Feeling of incomplete emptying in more than 3 times a week Feeling of anorectal obstruction or cramping in more than 3 times a week Need for manual maneuvers to facilitate defecation in more than 3 times a week Spontaneous bowel movements less than 3 times a week 55 years 85 years Both Dissatisfaction to participate in the research Intolerance to taking drugs Possible side effects (in the form of nausea, vomiting, severe abdominal pain, allergic reactions, etc.) Improper use of medication K59.0 Constipation Treatment - Drugs Treatment - Drugs Intervention group: For each patient is given 15 cc of fig and walnut syrup one hour before bedtime for two consecutive weeks Control group: For the control group, each patient is given 15 cc of lactulose syrup (as a remedy for constipation) one hour before bedtime for two consecutive weeks. Gastrointestinal pain. Timepoint: Painless stools was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session. Method of measurement: General Mizaj questionnaire. Constipation. Timepoint: Assessing constipation was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session. Method of measurement: General Mizaj questionnaire. Stool type. Timepoint: Stools with less stiffness intervention), after the last treatment session, and 30 days (one month) after the last treatment session. Method of measurement: General Mizaj questionnaire. Tabriz University of Medical Sciences Approved 2020-05-18 Ethics committee of Tabriz University of Medical Sciences University Street, 3rd Floor, Central Building, Tabriz University of Medical Sciences, Iran Tabriz West Azarbaijan Iran (Islamic Republic of)