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IRCT20200105046009N6 IRCT 2022-06-02 Babol University of Medical Sciences The Efficacy of Cassia Fistula syrup on functional chronic constipation in chronic kidney disease Evaluating the Efficacy of Cassia Fistula syrup on functional chronic constipation in chronic kidney disease (CKD) patients in comparison with the Lactulose (A Randomized Clinical Trial) 2022-06-06 anticipated 66 Complete https://irct.ir/trial/63865 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: Randomization is done using random permutation block methods. Random sequence generation is done online using the website www.sealedenvelope.com. The size of the blocks is 4. Drugs in two categories (intervention and standard treatment) are poured into identical containers by the pharmacist and sent to the study statistician. 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. Unlocking the codes will be done after the end of the study. In case of side effects, the drug code will be unlocked. Concealment: Drugs in groups A and B (without explanation of its content), reach the statistician and she performs the coding in blocks of four, Blinding description: Lactulose and Cassia Fistula syrups will be provided in a single form, with the same label by a pharmacist in the laboratory of medicinal plants 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, shape and taste of the drugs are different, it is not possible to blind the patients in this regard. Therefore, the study will be done as a single blind (assessor blind) study with uniform packaging. 3 Condition 1: chronic kidney disease. Condition 2: functional chronic constipation. Intervention 1: Intervention group: This group is given 30 cc of Cassia Fistula syrup (SANABEL DAROU Co.) daily divided into 3 doses for 14 days. Patients will be visited before the start of treatment, on the seventh day and the fourteenth day after the start of treatment and follow-up will be done one week after the end of treatment. Intervention 2: Control group: This group is given 30 cc of routine medicine, lactulose, (EXIR Co.) divided into 3 doses daily. Patients will be visited before the start of treatment, on the seventh day and the fourteenth day after the start of treatment and follow-up will be done one week after the end of treatment. 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 more information
public Seyyed Ali Mozaffarpur
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 4728 dr.mozaffarpur@mubabol.ac.ir Babol University of Medical Sciences scientific Seyyed Ali Mozaffarpur
School of Traditional Persian Medicine, Babol University of Medical Sciences, Ganjafruz Ave, Babol
Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 4728 dr.mozaffarpur@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Chronic kidney disease patients (CKD) with constipation Age between 18 to 80 years Having at least two criteria of ROME IV 18 years 80 years Both History of sensitivity to Cassia Fistula History of active infection in last month History of any surgery on GI system Pregnant women Organic constipation N18 K59.0 Chronic kidney disease (CKD) Constipation Treatment - Drugs Treatment - Drugs Intervention group: This group is given 30 cc of Cassia Fistula syrup (SANABEL DAROU Co.) daily divided into 3 doses for 14 days. Patients will be visited before the start of treatment, on the seventh day and the fourteenth day after the start of treatment and follow-up will be done one week after the end of treatment. Control group: This group is given 30 cc of routine medicine, lactulose, (EXIR Co.) divided into 3 doses daily. Patients will be visited before the start of treatment, on the seventh day and the fourteenth day after the start of treatment and follow-up will be done one week after the end of treatment. Frequency of defecation. Timepoint: Number of defecation per week. Method of measurement: Data gathering questionnaire. Frequency of straining in defecation. Timepoint: Frequency of straining in defecation per week. Method of measurement: Data gathering questionnaire. Feeling of incomplete emptying after defecation. Timepoint: Feeling of incomplete emptying after defecation per week. Method of measurement: Data gathering questionnaire. Frequency of using manual maneuver. Timepoint: Number of applying manual maneuver for defecation per week. Method of measurement: Data gathering questionnaire. Babol University of Medical Sciences Approved 2022-05-29 Ethics committee of Babol University of Medical Sciences Babol University of Medical sciences, Sargord Ghasemi avenue, Babol Babol Mazandaran Iran (Islamic Republic of)