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Allergic RhinitisNCT03700944

Yoga Training in Allergic Rhinitis Patients

A study testing Yoga training in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
Yoga training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteThailand
Study dates
1 Jan 2018to 29 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Faculty of Sports Science, Chulalongkorn University

    Bangkok, 10330

Other trials in Thailand

About this study

Official title: 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.

Being tested
Yoga training
Keywords
Allergic Rhinitis, Yoga, Cytokines, Rhinitis symptoms
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yoga trainingOther

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

Study groups in NCT03700944
Study groupRoleWhat they receive
YOGExperimentalThe yoga group (YOG) was required to complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week
Receives: Other: Yoga training
CONNo interventionThe control group (CON) had normal life.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 10 minutes

Secondary outcomes (1)

  1. Cytokine in nasal secretion

    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

    Measured: 10 Minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start1 Jan 2018
  3. Primary completion3 Mar 2018
  4. Study completion29 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03700944
Sponsor's protocol ID
SPSC 1
Status last verified
Oct 2018
First submitted
3 Oct 2018
Last updated
10 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28642859

  • 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.

    PubMed 23574691

  • 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.

    PubMed 23156847

  • 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.

    PubMed 21860974

  • 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.

    PubMed 22830969

  • 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.

    PubMed 26909898

  • 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.

    PubMed 26266115

  • 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.

    PubMed 25859450

  • 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.

    PubMed 26205020

Questions about this trial

What is this clinical trial studying?

A study testing Yoga training in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rhinitis symptom scores (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03700944, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.

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