Protocol summary
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Study aim
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Investigating the effect of valerian supplement (Valeriana officinalis) on the symptoms severity and quality of life in patients with irritable bowel syndrome (IBS)
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Design
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parallel-group, double-blind, randomized clinical controlled trial
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Settings and conduct
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After signing the consent form, 50 patients diagnosed with IBS will be randomly allocated into two groups to receive dried Valerian capsules (500 mg) or a placebo twice daily for eight weeks. Participants and researchers will be blinded with packages of Valerian or placebo coding with A or B with the same appearance. Outcomes will be assessed, through standard and valid questionnaires, at the beginning and the end of the study. All participants will be advised to follow a diet with low FODMAPs. Also, to control participants in terms of taking supplements and placebo and prevent the samples from falling, the follow-up of patients would occur every two weeks by phone.
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Participants/Inclusion and exclusion criteria
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1- Age 25 to 60 years2- Patients with irritable bowel syndrome according to the diagnosis of a gastroenterologist according to ROME-IV criteria (presence of heartache at least one day a week during the last 3 months in connection with at least two of the following cases: 1- problems with excretion 2- change in the frequency of defecation, 3- change in the shape and consistency of stool, and the absence of pathological findings in digestive examinations) 3- Suffering from certain diseases such as any active stomach-enteric disease or taking certain medicines 4- having an allergy to herbal products
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Intervention groups
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participants in the intervention group will receive dried valerian capsules (500 mg) twice daily for eight weeks. They receive advice and diet based on consuming foods containing low FODMAP.
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Main outcome variables
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IBS symptoms severity score and quality of life
General information
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Reason for update
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We changed the minimum age of patients to be included in the study (inclusion criteria) from 25 to 18 years. We increased the age range due to better access to patients. Also, the minimum age of 18 years is considered in several studies.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210427051098N3
Registration date:
2023-11-18, 1402/08/27
Registration timing:
registered_while_recruiting
Last update:
2026-02-23, 1404/12/04
Update count:
1
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Registration date
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2023-11-18, 1402/08/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-10-23, 1402/08/01
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Expected recruitment end date
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2024-03-10, 1402/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Evaluating the effect of Valerian on irritable bowel syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
1- Age 18 to 65 years
2- Patients with irritable bowel syndrome according to the diagnosis of a gastroenterologist according to ROME-IV criteria
Exclusion criteria:
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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Data analyser
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-09-11, 1402/06/20
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Ethics committee reference number
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IR.SSU.SPH.REC.1402.066
Health conditions studied
1
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Description of health condition studied
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Symptoms Severity and quality of life in patients with irritable bowel syndrome
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ICD-10 code
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k58.8
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ICD-10 code description
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Other and unspecified irritable bowel syndrome
Primary outcomes
1
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Description
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Symptoms severity of irritable bowel syndrome
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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IBS-Severity Scoring System (IBS-SSS) questionnaire.
2
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Description
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The quality of life in patients with irritable bowel syndrome
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Timepoint
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At the beginning of the study and after 8 weeks of intervention
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Method of measurement
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Irritable Bowel Syndrome Quality of Life Questionnaire
Secondary outcomes
1
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Description
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Anxiety and depression
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Timepoint
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At the beginning of the study and after 8 weeks of the intervention
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Method of measurement
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Hospital Anxiety and Depression Scale questionnaire
2
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Description
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Visceral Sensitivity
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Timepoint
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At the beginning of the study and after 8 weeks of the intervention
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Method of measurement
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Visceral Sensitivity Index questionnaire
3
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Description
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Patient Health
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Timepoint
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At the beginning of the study and after 8 weeks of the intervention
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Method of measurement
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Patient Health Questionnaire (PHQ)-12
4
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Description
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Sleep quality
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Timepoint
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At the beginning of the study and after 8 weeks of the intervention
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Method of measurement
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Pittsburgh Sleep Quality Index questionnaire (PSQI)
Intervention groups
1
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Description
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Intervention group: 500 mg capsule of dried Valerian (Valeriana officinalis) powder twice daily (1000 mg overall)
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Category
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Treatment - Other
2
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Description
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Control group: 500 mg capsule of starch powder twice daily (1000 mg overall)
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Yazd University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The non-identifiable statistical data of the participants will be shared collaboratively.
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When the data will become available and for how long
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Access will be provided upon publication of the relevant study article.
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To whom data/document is available
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Researchers at scientific institutions.
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Under which criteria data/document could be used
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Studies in the field of irritable bowel syndrome.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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Via email. zoh.khosravani@gmail.com
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Comments
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