NCT03700944

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

October 3, 2018

Last Update Submit

October 9, 2018

Conditions

Keywords

Allergic RhinitisYogaCytokinesRhinitis symptoms

Outcome Measures

Primary Outcomes (1)

  • Rhinitis symptom scores

    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 Outcomes (1)

  • Cytokine in nasal secretion

    10 Minutes

Study Arms (2)

YOG

EXPERIMENTAL

The yoga group (YOG) was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week

Other: Yoga training

CON

NO INTERVENTION

The control group (CON) had normal life.

Interventions

Complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week.

YOG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Asthma
  • Chronic rhino-sinusitis
  • Hypertension
  • Cardiovascular diseases
  • A smoking habit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Sports Science, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (9)

  • 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.

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 9, 2018

Study Start

January 1, 2018

Primary Completion

March 3, 2018

Study Completion

April 29, 2018

Last Updated

October 10, 2018

Record last verified: 2018-10

Locations