NCT02108769

Brief Summary

Our aim is to analyze two ancient Tamil practices (chanting and breathing exercise) if they are capable of stimulating saliva containing agents that can be beneficial to the nervous system. Our study subjects will perform Tamil chanting and Tamil breathing exercise. Saliva will be collected before, during and after the exercises. We will quantify the specific proteins in these salivary samples. The results will benefit further studies in various patient populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable alzheimer-disease

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable alzheimer-disease

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

October 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

April 3, 2014

Last Update Submit

April 7, 2014

Conditions

Alzheimer DiseaseNeurodegenerative DiseasesCancer

Keywords

YogaYogic breathingSalivaProteomicsLipdomicsNerve growth factorThirumanthiram

Outcome Measures

Primary Outcomes (1)

  • Nerve growth factor quantification

    Nerve growth factor will be quantified by ELISA and Western blotting.

    Three months from the date of sample collection

Secondary Outcomes (1)

  • Measuring changes in salivary constituents

    6 months from sample collection

Study Arms (2)

Yogic Breathing

EXPERIMENTAL

1. Chanting Om 1. Sharp deep inhalation through nostrils 2. Slow exhalation through mouth while chanting Om. At this step the subjects will perform a slow and complete exhalation. Repeat for 10 min. During the whole period of chanting, the subjects keep their eyes closed. 2. Yogic Breathing: 1. Check which of the two nostrils exhibit free flow of air. For the explanation purpose the nostril with free flow of air is treated as Nostril 1 and the other one as Nostril 2. 2. Close Nostril 2 and inhale a sharp deep breath through Nostril 1 and then close both the nostrils so no inhaled air escapes. Air should not escape through mouth either. This inhalation step should take about 4 seconds. 3. Hold breath in this position for about 16 seconds. 4. Open Nostril 2 and exhale for about 8 seconds. Complete exhalation is required. Abdomen will slowly curve-in as the subject exhales. This is normal and encouraged. No air should leak through the Nostril 1 or mouth. 5. Go to step a).

Behavioral: Yogic Breathing

Attention Control

ACTIVE COMPARATOR

The participants will read a text of their choice for 20 minutes.

Behavioral: Attention Control

Interventions

Yogic BreathingBEHAVIORAL

1. Chanting Om 1. Sharp deep inhalation through nostrils 2. Slow exhalation through mouth while chanting Om. At this step the subjects will perform a slow and complete exhalation. Repeat for 10 min. During the whole period of chanting, the subjects keep their eyes closed. 2. Yogic Breathing: 1. Check which of the two nostrils exhibit free flow of air. For the explanation purpose the nostril with free flow of air is treated as Nostril 1 and the other one as Nostril 2. 2. Close Nostril 2 and inhale a sharp deep breath through Nostril 1 and then close both the nostrils so no inhaled air escapes. Air should not escape through mouth either. This inhalation step should take about 4 seconds. 3. Hold breath in this position for about 16 seconds. 4. Open Nostril 2 and exhale for about 8 seconds. Complete exhalation is required. Abdomen will slowly curve-in as the subject exhales. This is normal and encouraged. No air should leak through the Nostril 1 or mouth. 5. Go to step a).

Also known as: Pranayama, Moochu Payirchi
Yogic Breathing
Attention ControlBEHAVIORAL

The participants will read a text of their choice for 20 minutes in a one-on-one session with the Yoga Instructor.

Also known as: Control
Attention Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anyone

You may not qualify if:

  • breathing problems (inability to breath through nostrils, chronic bronchitis, emphysema and asthma)
  • speech problems that would prevent chanting
  • inability to listen and follow exercise instructions
  • sinus congestion
  • Sjogren's syndrome
  • chronic dry mouth due to medication or other conditions
  • use of anti-cholinergic medications Informed consent will be obtained from each subject after completely describing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (5)

  • Aloe L, Rocco ML, Bianchi P, Manni L. Nerve growth factor: from the early discoveries to the potential clinical use. J Transl Med. 2012 Nov 29;10:239. doi: 10.1186/1479-5876-10-239.

    PMID: 23190582BACKGROUND

  • Kumar S, Nagendra H, Manjunath N, Naveen K, Telles S. Meditation on OM: Relevance from ancient texts and contemporary science. Int J Yoga. 2010 Jan;3(1):2-5. doi: 10.4103/0973-6131.66771.

    PMID: 20948894BACKGROUND

  • Rajasekaran R, Narayana A. Thirumular--pioneer of the immunology concept. Bull Indian Inst Hist Med Hyderabad. 2006 Jul-Dec;36(2):129-44.

    PMID: 18175648BACKGROUND

  • Twal WO, Wahlquist AE, Balasubramanian S. Yogic breathing when compared to attention control reduces the levels of pro-inflammatory biomarkers in saliva: a pilot randomized controlled trial. BMC Complement Altern Med. 2016 Aug 18;16:294. doi: 10.1186/s12906-016-1286-7.

    PMID: 27538513DERIVED

  • Balasubramanian S, Janech MG, Warren GW. Alterations in Salivary Proteome following Single Twenty-Minute Session of Yogic Breathing. Evid Based Complement Alternat Med. 2015;2015:376029. doi: 10.1155/2015/376029. Epub 2015 Mar 19.

    PMID: 25873979DERIVED

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseNeurodegenerative DiseasesNeoplasmsHereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental DisordersNervous System MalformationsHeredodegenerative Disorders, Nervous SystemPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Sundaravadivel Balasubramanian, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 9, 2014

Study Start

October 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

US(1)