NCT03555344

Brief Summary

Mantras are specialized energized sound or words, which are defined most important sound therapy in Vedic healing. Present study was undertaken to evaluate the immediate effect of specialized Mantra chant on cardiovascular parameters in high blood pressure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
Last Updated

July 17, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

June 1, 2018

Last Update Submit

July 14, 2018

Conditions

High Blood Pressure

Outcome Measures

Primary Outcomes (2)

  • Systolic Blood Pressure

    Change from baseline to half an hour

  • Diastolic Blood Pressure

    Change from baseline to half an hour

Secondary Outcomes (1)

  • Supine heart rate (HR)

    Change from baseline to half an hour

Study Arms (2)

Mantra Chikitsa

EXPERIMENTAL

Mantra chanting for 15 mins

Other: Mantra Chikitsa

Wait list control

NO INTERVENTION

Rest for 15 Mins

Interventions

Mantra ChikitsaOTHER

Specific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins.

Also known as: Mantra therapy
Mantra Chikitsa

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed and stable hypertension
  • on regular medication

You may not qualify if:

  • Individuals diagnosed with another lung disease,
  • Have psychiatric, musculoskeletal or cardiovascular diseases,
  • Being smokers
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Research Institute

Jaipur, Rajasthan, 302019, India

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR

  • Ravishankar Ramanathan

    Swamigal Trust for Vedic Science, India

    PRINCIPAL INVESTIGATOR

  • Puneet Sharma

    NMP Medical Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 13, 2018

Study Start

October 28, 2017

Primary Completion

May 15, 2018

Study Completion

May 30, 2018

Last Updated

July 17, 2018

Record last verified: 2018-06

Locations

IN(1)