Effect of saffron capsules compared to placebo in the adjunctive treatment of patients with irritable bowel syndrome with predominant diarrhea and constipation referring to Imam Khomeini Hospital in 2024, a double-blind clinical trial

The efficacy of saffron compared to placebo in adjunctive treatment of patients with irritable bowel syndrome (IBS) predominantly presenting with predominant diarrhea and constipation symptoms: A double-blind, clinical trial.

The study population for this research was measured using the G-power software, and it included 57 patients. We will employ restricted randomization using a block randomization approach. Block randomization is commonly used to achieve balance in the number of samples allocated to each study group. The block sizes are consistent, and in our trial, we will have two groups with 10 blocks of 6 (including 3 participants in the intervention group and 3 participants in the control group).

The selection of patients from the visitors to the gastroenterology clinic of Imam Khomeini Hospital in the year 1402 will be made, and random allocation concealment will be used.

Among patients referred to the Gastroenterology Clinic or Yalda Clinic at Imam Khomeini Hospital in 1402 (2023-2024), those who are above 18 years old, have been diagnosed with irritable bowel syndrome (IBS) based on Rome IV clinical criteria, do not have a major psychiatric disorder, and have no organic cause for their symptoms, will be included in the study if they provide informed consent.

Two defined capsule groups consist of Group 1 and Group 2. Group 1 contains 15 milligrams of saffron, while the next group is the placebo group (containing starch). Due to the double-blind nature of the study, neither the patient nor the study executor is aware of the type of active substance in Group 1 and Group 2.

severity of anxiety and depression; Severity of IBS symptoms

In this study, we will employ restricted randomization using a block randomization approach. Block randomization is commonly used to achieve balance in the number of samples allocated to each study group. This feature assists researchers in cases where interim analyses are necessary during the sampling process, ensuring that the number of samples assigned to each study group remains equal. The block sizes are consistent, and in our trial, we will have two groups with six blocks of ten (including three participants in the intervention group and three participants in the control group). Next, to randomly select the generated blocks, we will use software for generating random numbers, such as the R language. Six random numbers between 1 and 6 will be generated to select the blocks. For concealment, we will utilize allocation concealment, a method applied to execute the random sequence on study participants in such a way that the assigned group remains undisclosed before allocation. Sequentially numbered, sealed, opaque envelopes containing the randomized sequences will be used for this purpose.

We use random allocation concealment, which is applied in the method used for implementing random sequences on study participants, in such a way that the assigned group is not known before individual allocation. In this method, patient selection is randomized, and patients are enrolled with written consent and informed about all potential risks. They receive complete training for direct communication with the physician in case of any issues, but they are unaware of the use of the investigational drug or the reference drug. Additionally, drug coding ensures that data collection, statistical analysis, and drug administration remain blinded. After analyzing the data, the drug-naïve group and the reference drug group will be determined based on the same codes. Ultimately, the participants and the psychiatrists and gastroenterologists in the clinic who interact with the patients are kept blinded. Data are collected and analyzed using these codes, and after the analysis results, the codes are unblinded for the principal investigator to ensure proper blinding and data analysis.

Data on the primary outcome of the Irritable Bowel Syndrome (IBS) Questionnaire, which assesses IBS-related symptoms, and the Hospital Anxiety and Depression Scale (HADS), which assesses levels of anxiety and depression, are shareable.

The access period starts 24 months after the results are published

Study data is accessible to researchers working in academic institutions.

داده های غیر قابل شناسایی فردی در پرسشنامه سندرم روده تحریک پذیر و مقیاس اضطراب و افسردگی هاسپیتال که تحت درمان با پلاسبو و ماده سافرون ۱۵میلی گرم بوده اند قابل دسترسی می باشد.

To receive the documents, write to the email address of the project manager.

To receive the documents, write to the email address of the project manager.