Condition category
Digestive System
Date applied
24/11/2013
Date assigned
31/12/2013
Last edited
31/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 study’s 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

Contact information

Type

Scientific

Primary contact

Dr Senthamil Selvan

ORCID ID

Contact details

11722 Farina St
Norwalk
90650
United States of America

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

http://vivekanandayoga.org

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

Publication citations

Additional files

Editorial Notes