- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03700944
Yoga Training in Allergic Rhinitis Patients
October 9, 2018 updated by: Wannaporn Tongtako, Ph.D., Chulalongkorn University
The Effects of Yoga Training on Rhinitis Symptoms and Cytokines in Allergic Rhinitis Patients
The purpose of this study was to investigate effects of yoga training on rhinitis symptoms and cytokines in allergic rhinitis patients.
Twenty-seven allergic rhinitis patients, aged 18-45 year old, were randomized into 2 groups: control group (CON; n=14) and yoga group (YOG; n=13).
The control group had normal life and the yoga group was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week.
Physiological variables, lung function variables, allergic rhinitis symptoms variables, and cytokines level in nasal secretion variables were analyzed during pre-test and post-test.
The dependent variables between pre-test and post-test were analyzed by a paired t-test.
The dependent variables between groups were analyzed by independent t-test.
One way repeated measures ANOVA was used to compare the variables among pre-test, after 4 weeks, and after 8 weeks.
Differences were considered to be significant at p < 0.05.
Study Overview
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bangkok, Thailand, 10330
- Faculty of Sports Science, Chulalongkorn University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of allergic rhinitis diseases
- Clinical symptoms of persistent rhinitis (nasal congestion, sneeze, nasal itching, and running nose) for more than 4 days per week.
- Positive skin prick test (wheal diameter>3 mm.) to house dust mite (D. pteronyssinus) and using normal saline as the negative control.
- Stopped taking all medicine before the study such as antihistamine for at least 3 days, oral steroid and nasal steroid for at least 2 weeks and luekotriene receptor antagonist for at least a week prior to the study, but the patients could take pseudo ephedrine.
- Subjects were not to have participated in a regular exercise program for at least 6 months prior to the start of the study, and to avoid taking any form of dietary supplement during the course of the study.
Exclusion Criteria:
- Asthma
- Chronic rhino-sinusitis
- Hypertension
- Cardiovascular diseases
- A smoking habit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: YOG
The yoga group (YOG) was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week
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Complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week.
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|
NO_INTERVENTION: CON
The control group (CON) had normal life.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rhinitis symptom scores
Time Frame: 10 minutes
|
Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire.
The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol.
The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea.
The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cytokine in nasal secretion
Time Frame: 10 Minutes
|
Nasal secretions collection was performed bilaterally with filter paper strips (7x30 mm Whatman No.42, Whatman, Clifton, NJ).
Three filter paper strips were sequentially placed on each anterior portion of the inferior turbinate for 10 min.
This filter paper strips were collected into appropriate tubes and centrifuged at 3,000 rpm for 5 min at 4 °C and immediately frozen at -70 °C until later analysis.The levels of cytokines were determined by using Sandwich ELISA technique
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10 Minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Caggiano S, Cutrera R, Di Marco A, Turchetta A. Exercise-Induced Bronchospasm and Allergy. Front Pediatr. 2017 Jun 8;5:131. doi: 10.3389/fped.2017.00131. eCollection 2017.
- Cheema BS, Houridis A, Busch L, Raschke-Cheema V, Melville GW, Marshall PW, Chang D, Machliss B, Lonsdale C, Bowman J, Colagiuri B. Effect of an office worksite-based yoga program on heart rate variability: outcomes of a randomized controlled trial. BMC Complement Altern Med. 2013 Apr 10;13:82. doi: 10.1186/1472-6882-13-82.
- Tongtako W, Klaewsongkram J, Jaronsukwimal N, Buranapraditkun S, Mickleborough TD, Suksom D. The effect of acute exhaustive and moderate intensity exercises on nasal cytokine secretion and clinical symptoms in allergic rhinitis patients. Asian Pac J Allergy Immunol. 2012 Sep;30(3):185-92.
- Teixeira RUF, Zappelini CEM, Alves FS, da Costa EA. Peak nasal inspiratory flow evaluation as an objective method of measuring nasal airflow. Braz J Otorhinolaryngol. 2011 Jul-Aug;77(4):473-480. doi: 10.1590/S1808-86942011000400011.
- Yadav RK, Magan D, Mehta N, Sharma R, Mahapatra SC. Efficacy of a short-term yoga-based lifestyle intervention in reducing stress and inflammation: preliminary results. J Altern Complement Med. 2012 Jul;18(7):662-7. doi: 10.1089/acm.2011.0265.
- Zhao N, Liu HJ, Sun YY, Li YZ. Role of interleukin-6 polymorphisms in the development of allergic rhinitis. Genet Mol Res. 2016 Jan 8;15(1). doi: 10.4238/gmr.15016987.
- Vijayaraghava A, Doreswamy V, Narasipur OS, Kunnavil R, Srinivasamurthy N. Effect of Yoga Practice on Levels of Inflammatory Markers After Moderate and Strenuous Exercise. J Clin Diagn Res. 2015 Jun;9(6):CC08-12. doi: 10.7860/JCDR/2015/12851.6021. Epub 2015 Jun 1.
- Rajbhoj PH, Shete SU, Verma A, Bhogal RS. Effect of yoga module on pro-inflammatory and anti-inflammatory cytokines in industrial workers of lonavla: a randomized controlled trial. J Clin Diagn Res. 2015 Feb;9(2):CC01-5. doi: 10.7860/JCDR/2015/11426.5551. Epub 2015 Feb 1.
- Netam R, Yadav RK, Khadgawat R, Sarvottam K, Yadav R. Interleukin-6, vitamin D & diabetes risk-factors modified by a short-term yoga-based lifestyle intervention in overweight/obese individuals. Indian J Med Res. 2015 Jun;141(6):775-82. doi: 10.4103/0971-5916.160698.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2018
Primary Completion (ACTUAL)
March 3, 2018
Study Completion (ACTUAL)
April 29, 2018
Study Registration Dates
First Submitted
October 3, 2018
First Submitted That Met QC Criteria
October 6, 2018
First Posted (ACTUAL)
October 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
October 10, 2018
Last Update Submitted That Met QC Criteria
October 9, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SPSC 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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