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IRCT20100704004306N11 IRCT 2020-02-13 Babol University of Medical Sciences The efficacy of cassia fistula syrup on constipation in pregnant women The efficacy of cassia fistula syrup on constipation in pregnant women 2020-02-09 anticipated 70 Complete https://irct.ir/trial/38669 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed for two groups in blocks of 4. Patients will randomly divide into two groups: intervention 1 and intervention 2 (intervention 1: nutritional and physical activity recommendations and intervention 2: dietary recommendations and physical activity + cassia fistula syrup). Random permuted blocks (blocks containing 4 of A and B) will be prepared and eligible samples will be assigned to two intervention groups. Intervention groups 1 and 2 are each marked with one of the letters A and B, and cards with different quadruple combinations of letters A and B will be produced. Picking up the cards randomly will determine the following 4 patients will be placed in which of the intervention groups. 1-2 Constipation in pregnant wemon. Intervention 1: The intervention group (35 pregnant women) will received nutritional and physical activity recommendations. Also, for two weeks,1 tbsp containing 10 cc of the cassia fistula syrup ("Flubel" syrup produced by Sanabel Daru Co.) twice a day will be given. If constipation does not improve, patients can increase the dose of the drug to 30 cc daily and record this amount. Intervention 2: In the control group (35 pregnant women) only nutritional and physical activity recommendations are given.These recommendations include a written text on the need for adequate fluids, fiber foods, and the need for regular daily physical activity. 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 No more information
public Rozhin tahmasbi
Babol University of Medical Sciences,Ganj farooz st.Babol
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3227 4881 tahmasebi.r2@gmail.com Babol University of Medical Sciences scientific Rozhin tahmasbi
Babol University of Medical Sciences,Ganj afrooz st.,Babol
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3227 4480 tahmasebi.r2@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Satisfaction with entering the study Age between 17and 38 years Gestational age 28-40 weeks Diagnosis of constipation based on study criteria (defecation less than 3 times a week, pain while defecating and stool stiffness) 17 years 38 years Female High risk pregnancy (twin pregnancy, abortion, placenta previa, preterm labor, fetal anomaly) History of inflammatory bowel disease (Crohn's disease, ulcerative colitis) History of intestinal surgery Smoking and drug abuse Rheumatologic diseases K59.0 Constipation Treatment - Drugs Lifestyle The intervention group (35 pregnant women) will received nutritional and physical activity recommendations. Also, for two weeks,1 tbsp containing 10 cc of the cassia fistula syrup ("Flubel" syrup produced by Sanabel Daru Co.) twice a day will be given. If constipation does not improve, patients can increase the dose of the drug to 30 cc daily and record this amount. In the control group (35 pregnant women) only nutritional and physical activity recommendations are given.These recommendations include a written text on the need for adequate fluids, fiber foods, and the need for regular daily physical activity. Frequency of defecation per week. Timepoint: Before intervention and one and two week after intervention. Method of measurement: Constipation cheklist. Babol University of Medical Sciences Approved 2019-03-03 Ethics committee of Babol University of Medical Sciences Ganj Afrooz ave. Babol university of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)