]>
IRCT20210427051098N3 IRCT 2023-11-18 Yazd University of Medical Sciences Evaluating the effect of Valerian on irritable bowel syndrome Evaluating the effect of Valerian (Valeriana officinalis) supplementation on the symptoms severity and quality of life in patients with irritable bowel syndrome: A randomized and double-blind clinical trial 2023-10-23 anticipated 50 Complete https://irct.ir/trial/70356 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After determining the eligible people and obtaining their consent, the participants will be divided into two groups [intervention (valerian) or control (starch)] by random allocation method. Firstly, each individual will receive a specific code number. Then all code numbers will be entered into random allocation software. Software inputs will include the total number of samples and the number of treatment groups (intervention and control). The software output will include random numbers assigned to two groups. The allocation ratio will be 1:1. Each participant will have an equal chance of being in each group, and participants in the study will not be able to predict the type of intervention they receive, Blinding description: In this study, researchers and patients will be blinded using supplements or placebos that have the same appearance and the same packaging. Coding is done by someone outside the study. The given codes will be provided to the researchers after the statistical analysis of the data and for writing the article. The codes will be defined as A and B. 3 Symptoms Severity and quality of life in patients with irritable bowel syndrome. Intervention 1: Intervention group: 500 mg capsule of dried Valerian (Valeriana officinalis) powder twice daily (1000 mg overall). Intervention 2: Control group: 500 mg capsule of starch powder twice daily (1000 mg overall). Yes - There is a plan to make this available What will be shared: The non-identifiable statistical data of the participants will be shared collaboratively. When: Access will be provided upon publication of the relevant study article. To whom: Researchers at scientific institutions. Conditions: Studies in the field of irritable bowel syndrome. Where to obtain: To receive the documents through email, please send your request and the reason for it to person responsible for general inquiries of the study. After reviewing it in the shortest possible time, a response to your request will be sent. Email address: zoh.khosravani@gmail.com How to obtain: Via email. zoh.khosravani@gmail.com Comments:
public Zohreh Khosravani Shooli
Yazd university of medical sciences, Basirat St ., Shohadaye gomnam Blvd., Alem Sq, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 Zoh.khosravani@gmail.com Yazd University of Medical Sciences scientific Sayyed Saeid Khayyatzadeh
Yazd university of medical sciences, Basirat St ., Shohadaye gomnam Blvd., Alem Sq, Yazd, Iran.
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 Khayyatzadeh@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) 1- Age 18 to 65 years 2- Patients with irritable bowel syndrome according to the diagnosis of a gastroenterologist according to ROME-IV criteria 18 years 65 years Both Dietary changes during the study Unwillingness to continue attending the study Pregnancy or breastfeeding during the study Hospitalization Suffering from certain diseases such as any active stomach-enteric disease or taking certain medicines Having an allergy to herbal products k58.8 Other and unspecified irritable bowel syndrome Treatment - Other Placebo Intervention group: 500 mg capsule of dried Valerian (Valeriana officinalis) powder twice daily (1000 mg overall) Control group: 500 mg capsule of starch powder twice daily (1000 mg overall) Symptoms severity of irritable bowel syndrome. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: IBS-Severity Scoring System (IBS-SSS) questionnaire. The quality of life in patients with irritable bowel syndrome. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Irritable Bowel Syndrome Quality of Life Questionnaire. Anxiety and depression. Timepoint: At the beginning of the study and after 8 weeks of the intervention. Method of measurement: Hospital Anxiety and Depression Scale questionnaire. Visceral Sensitivity. Timepoint: At the beginning of the study and after 8 weeks of the intervention. Method of measurement: Visceral Sensitivity Index questionnaire. Patient Health. Timepoint: At the beginning of the study and after 8 weeks of the intervention. Method of measurement: Patient Health Questionnaire (PHQ)-12. Sleep quality. Timepoint: At the beginning of the study and after 8 weeks of the intervention. Method of measurement: Pittsburgh Sleep Quality Index questionnaire (PSQI). Yazd University of Medical Sciences Approved 2023-09-11 Ethics Committee of Shahid Sadoughi University of Medical Sciences Ethics Committee of Shahid Sadoughi University of Medical Sciences, Shahid Sadoughi University of Medical Sciences and Health Services Campus- Shohadaye Gomnam Blvd- Alem Square- Yazd Yazd Yazd Iran (Islamic Republic of)