Plain English Summary
Background and study aims
We are carrying out a study of therapeutic effect of yoga in patients with irritable bowel syndrome (IBS) (gut disorder). Our goal is to find if yoga is a viable alternative treatment option to be included for IBS patients. The studys findings should help to include yoga as therapy for IBS patients and to enhance the quality of life in IBS patients.
Who can participate?
All adults 18 years of age and older with IBS within the southern California region to enroll in the study.
What does the study involve?
The present study involves postures, breathing control and meditation on physical and emotional symptoms in adults, suffering from IBS. All the participants will be divided randomly into three groups, yoga group, combination group and wait listed control group. All participants will participate in the three assessments at the start (0 week), mid (end of 6 weeks) and the end (end of 12 weeks). Every participant will be in the program for 12 weeks. At the end of the study, we will compare the IBS symptoms severity and quality of life between the groups, specifically yoga and combination groups against the control group.
What are the possible benefits and risks of participating?
Besides gaining relief from the symptoms of IBS, participants will be learning to better manage these symptoms and causes in the future as the changes comes from within oneself through yoga practices. Participants will be adding to the knowledge about a new long-term approach of IBS management. We hope that this new approach can help in finding a way to reduce the prevalence of IBS. It will also help to reduce the amount of medication to control the symptoms of IBS. The risks are none, when Yoga postures are done correctly. The principal researcher and the team will take every precaution to avoid any kind of wrong postures.
Where is the study run from?
This study is run from the White Memorial Medical Center (WMMC), Los Angeles, USA.
When is the study starting and how long is it expected to run for?
Recruitment started in late 2012 and is expected to run for 2 years.
Who is funding the study?
Vivekananda Yoga Research Foundation- Los Angeles (VYASA-LA) is funding the project.
Who is the main contact?
Dr Senthamil Selvan, senthamils59@gmail.com
Vijaya Kavuri, vijaya_kavuri@yahoo.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IAYT-IBS-001
Study information
Scientific title
A randomized controlled study to determine whether the integrated approach of yoga therapy is effective in managing/reducing the symptoms of irritable bowel syndrome patients
Acronym
IAYT-IBS
Study hypothesis
It is hypothesized that the integrated approach of yoga therapy will benefit the irritable bowel syndrome (IBS) patients in reducing the severity of IBS symptoms and improving quality of life compared to a wait-list control group.
Null hypothesis: there will be no difference in the severity of IBS symptoms and quality of life in the yoga and combination groups compared to the wait-list control group.
Ethics approval
White Memorial Medical Center Institutional Review Board, 02/06/2012, ref: IAYT-IBS-001-VYASA-LA/WMMC
Study design
Three groups, three time assessments, randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Irritable bowel syndrome
Intervention
The study will involve 75 IBS patients aged 18 and older, female/male, to complete the study. They will be randomized into one of the three groups: Yoga group, Combination group and Wait-listed Control group. Participation will be for 3 months (12 weeks).
Yoga group: will participate in three, one hour long, yoga classes a week, for 12 weeks. They are also asked to voluntarily reduce their medication to three times a week.
Combination group: will participate in three, one hour long, yoga classes a week for 12 weeks. They can take their medication as directed by their physician.
Wait-listed Control group: will continue with their medication and are encouraged to walk three times a week.
All groups will come for three assessments: baseline (before starting the study period, 0 week), mid assessment (end of 6 weeks) and post assessment (end of 12 weeks).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
2. Irritable Bowel Syndrome Quality of Life (IBS-QOL)
Time points of measurements: 0 weeks (base line), 6 weeks (mid) and 12 weeks (end).
Secondary outcome measures
1. Hospital Anxiety and Depression Scale (HADS)
2. Autonomic Nervous System Symptom Score (ANS-SS)
3. Body Mass Index
4. Physical Flexibility - hip and trunk
5. Physical Flexibility shoulder
6. ANS - Sympathetic Reactivity Hand Grip test (4 minutes)
7. ANS - Sympathetic Reactivity Mental Math test (5 minutes)
8. ANS - Parasympathetic Reactivity Deep Breathing test (3 minutes)
9. ANS - Parasympathetic Reactivity 30:15 (standing from a lying down position)
Time points of measurements: 0 weeks (base line), 6 weeks (mid) and 12 weeks (end).
Overall trial start date
01/11/2012
Overall trial end date
31/10/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. IBS patients, male and female adults 18 years of age and older
2. Consent to participate in the study
3. Not enrolled in any other alternative medical program
4. Not practiced yoga in the last 6 months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
75 IBS patients to complete the study (not including dropouts)
Participant exclusion criteria
1. Physical disability that prevents the patient from doing yoga
2. Pregnancy
3. Mental disability that prevents the patient from doing yoga
4. Any organic bowel disease
Recruitment start date
01/11/2012
Recruitment end date
31/10/2014
Locations
Countries of recruitment
United States of America
Trial participating centre
11722 Farina St
Norwalk
90650
United States of America
Sponsor information
Organisation
Vivekananda Yoga Research Foundation - Los Angeles (Vivekananda Yoga Anusandhana Samsthana - Los Angeles) (USA)
Sponsor details
11722 Farina Street
Norwalk
90650
United States of America
Sponsor type
Research organisation
Website
Funders
Funder type
Other
Funder name
Vivekananda Yoga Research Foundation - Los Angeles (Vivekananda Yoga Anusandhana Samsthana - Los Angeles) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary