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IRCT20120718010324N79 IRCT 2023-07-12 Tabriz University of Medical Sciences Effect of combined fig and walnut syrup on constipation Evaluation the Effect of Combined Fig-Walnut Syrup compared to fig syrup and placebo on functional Constipation and Quality of Life in Pregnant Women: A Randomized Controlled Clinical Trial 2023-08-01 anticipated 90 Complete https://irct.ir/trial/70936 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants in the study will be assigned to two intervention groups (recipients of combined fig-walnut syrup, recipient of fig syrup) and a control group (recipient of placebo) using a random block method with a block size of six and with an allocation ratio of 1:1:1. A computerized program ( randomizer software) will be used to create the allocation sequence. For allocation concealment, the allocation sequence will be determined by someone not involved in the study. For blinding, drugs and placebo will be provided in the same opaque bottles that numbered sequentially, Blinding description: The participants, researcher and data analyst will be blinded completely in this study. Drug and placebo will be similar in appearance (shape, color, smell) and will be prepared in similar opaque bottles. 3 Functional constipation. Intervention 1: Intervention group 1: The participants (30 people) in the first group will use the combined fig-walnut syrup every night, half an hour before going to sleep, in the amount of 15 ml, for two weeks. Intervention 2: Intervention group 2: The participants (30 people) in the second group will use the fig syrup every night, half an hour before going to sleep, in the amount of 15 ml, for two weeks. Intervention 3: Control group: Participants (30 people) in the control group will use 15 ml of placebo syrup every night, half an hour before going to bed, for two weeks. 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 Participant data is confidential.
public Roghayyeh Valizadeh
Faculty of Nursing and Midwifery, South Shariati street, Tabriz
Tabriz Iran (Islamic Republic of) 5135963777 +98 41 3523 0741 r.valizadeh31@gmail.com Tabriz University of Medical Sciences scientific Mojgan Mirghafourvand
Faculty of Nursing & Midwifery, South Shariati Street
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 mirghafourvandm@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Healthy singleton pregnant women with constipation Gestational age less than 32 weeks Being literate in reading and writing 15 years 49 years Female Receiving medication for constipation less than one week before the study Endocrine disorders (hypothyroidism) Intestinal diseases such as Hirschiprong, intestinal obstruction, colon cancer, intestinal hernia or stricture, inflammatory bowel disease, previous gastrointestinal surgery, spinal abnormalities and anorectal injuries such as fistula according to the person's own statement Having a high-risk pregnancy including diabetes (people with overt diabetes and disturbed GTT and people who have fasting blood sugar higher than normal range in the first trimester tests), high blood pressure, chronic diseases that affect pregnancy such as heart, vascular, lung diseases and .... according to the person's own statement and the medical record Having an addiction to drugs and smoking Previous allergy to figs or walnuts K59.0 Constipation Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: The participants (30 people) in the first group will use the combined fig-walnut syrup every night, half an hour before going to sleep, in the amount of 15 ml, for two weeks. Intervention group 2: The participants (30 people) in the second group will use the fig syrup every night, half an hour before going to sleep, in the amount of 15 ml, for two weeks. Control group: Participants (30 people) in the control group will use 15 ml of placebo syrup every night, half an hour before going to bed, for two weeks. Number of bowel movements per week. Timepoint: Before the intervention, the first, second, third and fourth weeks. Method of measurement: Questionnaire of functional constipation. Quality of life score. Timepoint: Before starting the intervention, End of the fourth week. Method of measurement: Specific quality of life questionnaire during pregnancy. Straining during defecation. Timepoint: In the first, second, third and fourth weeks after the intervention. Method of measurement: Questionnaire of constipation. Sensation of incomplete evacuation. Timepoint: In the first, second, third and fourth weeks after the intervention. Method of measurement: Questionnaire of constipation. Sensation of anorectal obstruction. Timepoint: In the first, second, third and fourth weeks after the intervention. Method of measurement: Questionnaire of constipation. Manual maneuvers to facilitate defecation. Timepoint: In the first, second, third and fourth weeks after the intervention. Method of measurement: Questionnaire of constipation. Stool consistency. Timepoint: In the first, second, third and fourth weeks after the intervention. Method of measurement: Questionnaire of constipation. Use of magnesium milk. Timepoint: At the end of the intervention. Method of measurement: Checklist. First time of elimination of symptoms and improvement in constipation. Timepoint: At the end of the intervention. Method of measurement: Questionnaire of constipation. Satisfaction. Timepoint: At the end of the first, second, third and fourth weeks. Method of measurement: Checklist. Tabriz University of Medical Sciences Approved 2023-06-26 Ethics committee of Tabriz University of Medical Sciences Reaserch department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht street, Azadi street Tabriz East Azarbaijan Iran (Islamic Republic of)