| CTRI Number |
CTRI/2025/10/095808 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of AUM chanting on hrv, Salivary nitric oxide and stress in healthy persons |
|
Scientific Title of Study
|
Immediate effect of AUM chanting on autonomic functions, salivary nitric oxide and stress in healthy individuals: a randomisied controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meghansh Gautam |
| Designation |
PG Schloar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
First Floor
Room No 02
SDM College of Naturopathy and Yogic Sciences
Ujire
Dakishna kannada
karnataka
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8826394625 |
| Fax |
|
| Email |
drmeghansh01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bindu Shridhar |
| Designation |
Professor and Dean |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
SDM College of Naturopathy and Yogic Sciences
Ujire
Dakishna kannada
karnataka
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Meghansh Gautam |
| Designation |
PG Schloar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga First Floor
SDM College of Naturopathy and Yogic Sciences
Ujire
Dakishna kannada
karnataka
Dakshina Kannada KARNATAKA 574240 India |
| Phone |
8826394625 |
| Fax |
|
| Email |
drmeghansh01@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Naturopathy and Yogic Sciences, Ujire, Dakishna kannada, karnataka- 574216 |
| SDM Yoga and Nature Cure Hospital Shanthivana, Dharmasthala, Dakishna kannada, Karnataka- 574240 |
|
|
Primary Sponsor
|
| Name |
Dr Meghansh Gautam |
| Address |
A 154, Gali No 12,Kh No 98/1/2 Wazirabad,
Delhi 110084 |
| Type of Sponsor |
Other [Self Sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meghansh Gautam |
SDM Yoga and Nature Cure Hospital, Shanthivana |
Department of Yoga, First floor,SDM Yoga and Nature Cure Hospital, Shanthivana
Dharmasthala, Dakshina Kannada, Karnataka - 574216 Dakshina Kannada KARNATAKA |
08826394625
drmeghansh01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AUM kara Chanting |
Sequential chanting for 10 mins
A kara chanting for 2.5 minutes
U kara chanting for 2.5 minutes
M kara chanting for 2.5 minutes
AUM kara chanting for 2.5 minutes
with sitting in comfortable sitting position |
| Comparator Agent |
OM kara Chanting |
OM kara chanting for 10 mins with sitting in comfortable sitting position |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Self-reported Healthy Individuals
2. Not on any medications or supplements
3. PSS-10 score between 0 and 26 |
|
| ExclusionCriteria |
| Details |
1. Systemic illness
2. History of viral infection in past 2 weeks
3. Analgesics, opioid use in last week.
4. Pregnancy and Women during Menstruation.
5. PSS-10 score more than 26 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability
Salivary nitric oxide
Visual analogue scale for stress
|
2 to 5 mins before starting intervention and immediately or within 2 to 5 mins post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood pressure
Mean arterial pressure
Breath holding time |
2 to 5 mins before starting intervention and immediately or within 2 to 5 mins post intervention |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial will evaluate the immediate effects of structured sequential A, U, M, and AUM chanting versus standard OM chanting on autonomic function, salivary nitric oxide, and perceived stress in healthy young adults aged 18 to 30 years from SDM Institutions, Ujire, Karnataka. Participants will be randomized to either 10 minutes of sequential A, U, M, AUM chanting 2.5 minutes each or 10 minutes of OM chanting, performed with slow, controlled exhalations in a quiet sitting posture. Primary outcomes are heart rate variability (time and frequency domains like SDNN, RMSSD, pNN50, LF, HF, LF HF ratio), heart rate, systolic and diastolic blood pressure, mean arterial pressure, and breath-holding time, assessed 5 minutes before and within 5 minutes post intervention in supine position using Power Lab HRV analysis and a validated BP monitor, salivary nitrite will be quantified via Berkeley test strips with the manufacturer’s app in the early morning. Secondary outcome is perceived stress using a 10 point visual analog scale immediately pre and post intervention. Apparently healthy males and females, 18 to 30 years, not on medications or supplements, no substance use, no recent illness, and not engaged in regular mind body practices. Exclusions include systemic illness, recent viral infection, pregnancy or menstruation on test day, analgesic or opioid use in prior week, and PSS 10 less than 26. Sample size is calculated using g power software and it is found to be 58, so 29 per group. The analyses will be done using JAMOVI software include paired tests within groups and independent tests between groups per normality. The study aims to generate immediate, mechanistic evidence on autonomic regulation and nitric oxide pathways with structured syllabic chanting compared to OM, with institutional ethics approval obtained. |