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)

Main Objective: Determining the efficacy of Cassia Fistula syrup on functional chronic constipation in chronic kidney disease patients comparing to Lactulose according to ROME IV Specific objectives: 1-Determining number of defecation per week in consumption of Cassia Fistula comparing to lactulose 2-Amount of straining in....3-Amount of stool stiffness in....4-Amount of feeling of incomplete emptying per week....5-Amount of using manual maneuvers...6-Side effects of syrup based on visits and lab tests

In this randomized clinical trial, 66 patients with chronic kidney disease having constipation, will be assigned randomly with single blindness into two parallel groups of drug and control, followed up for 2 weeks.

The population is patients with chronic kidney disease having constipation who are being treated in nephrology fields of Babol University of Medical Sciences. It will be performed as a single-blind (assessor blind) study with uniformity of drug packaging.

Inclusion criteria: 1.Chronic kidney disease patients with constipation 2.Age between 18-80 years 3.Having at least two criteria of ROME IV Exclusion criteria: 1.Sensitivity to Cassia Fistula 2.Active infection in last month 3.Surgery on GI 4.Pregnancy 5.Organic constipation

Patients with chronic kidney disease having constipation are divided into two groups. The medication group is given 30cc of Cassia Fistula syrup daily divided into 3 doses for 14 days and the control group is given 30cc of lactulose divided into 3 doses daily. Patients will be visited before the start of treatment, on the 7th and 14th day and follow-up will be done one week after the end of treatment.

Frequency of defecation; straining in defecation; Frequency of hard stools; Feeling of incomplete emptying; Using manual maneuver; Stiff stools

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.

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.

Information will be accessible after publication in accordance with the rules and regulations.

The access period will start 6 months after the results are published.

Researchers working in academic and scientific institutions

Systematic review and meta-analysis of data

Submit a request via email to seyyedali1357@gmail.com and after review by the project manager

Submit a request via email to seyyedali1357@gmail.com and after review by the project manager