The effect of Cassia fistula syrup on quality of life in patients undergoing hemodialysis with constipation

determination The effect of Cassia fistula syrup on quality of life in patients undergoing hemodialysis with constipation

In this study, which was performed as a randomized placebo-controlled clinical trial in a three-way blind and phase 3 study on 106 patients, randomization was performed using the randomized permutation block method.

Patients undergoing hemodialysis, referred to hemodialysis centers of Shahrekord University of Medical Sciences and having a diagnosis of constipation are randomly assigned to two groups of drugs and placebo. A single shape, with the same label and the same taste and smell will be prepared by a pharmacist in the laboratory of the Clinical Trial Research Center of Shahed University. The only person who knows the nature of syrups is the pharmacist who makes the medicine. To hide the treatment process (Concealment), the drugs in two groups A and B (without explaining its content), reach a statistician and he performs the coding in blocks of four.

Inclusion criteria: age 18 years and above - having at least two criteria of Rome-3 criteria Criteria for non-inclusion: - No gastrointestinal diseases, including irritable bowel syndrome, secondary constipation or neurological diseases (Parkinson, depression, etc.), non-neurological diseases (hypothyroidism, hypokalemia, etc.) - History of any surgery digestive system

The drug group is given 10% Cassia fistula syrup in the amount of 10 ml twice a day for 30 days. The same amount of placebo syrup is given. If constipation does not improve, patients can increase the dose of the drug or placebo to 30 ml per day.

Quality of Life ; Constipation; Itching

After conducting the pilot study and re-determining the size of the sample as well as the total number of patients eligible to enter the study, the number of samples was reduced to 70 people

Randomization is done using random permutation blocks method. The size of the blocks is 4. Drugs in two categories (drug and placebo) are made 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 the codes will be done after the end of the study. In case of side effects, the drug code will be unlocked. Blinding is such that placebo syrup and medicine in a single form, with the same label and the same taste and smell will be prepared by a pharmacist in the laboratory of the Clinical Trial Research Center of Shahed University. The only person who knows the nature of syrups is the pharmacist who makes the medicine. To hide the treatment process (Concealment), the drugs in two groups A and B (without explaining its content), reach a statistician and he performs the coding in blocks of four.

Blinding is such that placebo syrup and medicine in a single form, with the same label and the same taste and smell will be prepared by a pharmacist in the laboratory of the Clinical Trial Research Center of Shahed University. The only person who knows the nature of syrups is the pharmacist who makes the medicine.