]>
IRCT20200105046009N3 IRCT 2020-07-17 Babol University of Medical Sciences The effect of Cassia Fistula syrup in geriatrics consipation The effect of Cassia Fistula syrup in geriatrics consipation in comparison with the lactulose 2020-06-22 anticipated 70 Complete https://irct.ir/trial/49123 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, a total of 70 patients will be admitted and patients will be randomly divided into two groups. The first group are patients who receive floss syrup and the second group are patients who receive lactulose syrup. The data required for this study will also be collected through questionnaires 1 to 6, Randomization description: The size of the blocks is 4. Drugs in two categories (drug and standard treatment) are poured into identical containers by the study pharmacist and sent to the study statistics specialist. The statistician encodes them and places them in blocks of 4 (containing 2 numbers from each group). And is given to the researcher in blind form. Unlock codes will be done after reading. In case of side effects, the drug code will be unlocked, Blinding description: Lactulose and Floss syrup in a single form, with the same label, will be prepared by a pharmacist in the Medicinal Plants Laboratory of the Faculty of Iranian Medicine, Babol University of Medical Sciences. The only person who knows the nature of the syrups is the pharmacist involved in the project. Due to the fact that the consistency and shape of the drugs are different, it is not possible to blind the patient in this regard. Therefore, the study will be done one-way blind (evaluator blinding). 3 geriatrics consipation. Intervention 1: Intervention group: Cassia fistula syrup prepared and standardized in the Laboratory of Medicinal Plants of Babol School of Traditional Medicine, 30 cc daily (in three separate doses) for 14 days for the elderly with constipation and on days 0 (before Drug initiation), 7 and 14 are evaluated. Intervention 2: Control group: Lactulose syrup (made by Exir Company), 30 cc daily (in three separate doses) for 14 days for the elderly with constipation and on days 0 (before Drug initiation), 7 and 14 are evaluated. 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 There is no further information
public seyyed Ali Mozaffarpur
Ganjafrooz Street
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 seyyedali1357@gmail.com Babol University of Medical Sciences scientific seyyed Ali mozaffarpur
Ganjafrooz Street
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 seyyedali1357@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age over 60 years Diagnosis of constipation based on ROME IV criteria 60 years no limit Both The presence of organic diseases is the basis for constipation Presence of cardiovascular disease, neurological disease, metabolic disease or mental disorders. Hematologic disease or malignant tumor (unless recurrent in the last 5 years) History of alcohol use or substance abuse K59.0 Constipation Treatment - Drugs Other Intervention group: Cassia fistula syrup prepared and standardized in the Laboratory of Medicinal Plants of Babol School of Traditional Medicine, 30 cc daily (in three separate doses) for 14 days for the elderly with constipation and on days 0 (before Drug initiation), 7 and 14 are evaluated. Control group: Lactulose syrup (made by Exir Company), 30 cc daily (in three separate doses) for 14 days for the elderly with constipation and on days 0 (before Drug initiation), 7 and 14 are evaluated. Frequency of defecation. Timepoint: Number per week. Method of measurement: counting and recording the number of defecation per week. Feeling of incomplete emptying after defecation. Timepoint: Before intervention and 7 and 14 days after intervention. Method of measurement: Daily questionnaire on quality of defecation. Number of times of manual maneuver in defecation. Timepoint: Before intervention and 7 and 14 days after intervention. Method of measurement: Daily questionnaire on quality of defecation. Stiffness of stool. Timepoint: Before intervention and 7 and 14 days after intervention. Method of measurement: Visual Analogue Scale. Quality of Life. Timepoint: Before intervention and 14 days after intervention. Method of measurement: Patient Assessment of Constipation Quality of Life Questionnaire (the Persian Version). Babol University of Medical Sciences Approved 2020-06-28 Ethics committe of Shiraz University of Medical Sciences Ganjafrooz Street Babol Mazandaran Iran (Islamic Republic of)