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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03700944
Other study ID # SPSC 1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date April 29, 2018

Study information

Verified date October 2018
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date April 29, 2018
Est. primary completion date March 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Thailand Faculty of Sports Science, Chulalongkorn University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & 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. Review. — View Citation

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 C — View Citation

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- — View Citation

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. — View Citation

Teixeira RU, Zappelini CE, 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):473-80. English, Portuguese. — View Citation

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 Aller — View Citation

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 20 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 10 Minutes
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