Effect of Mantra on Hypertensive Patients | NCT03555344

Studies
Effect of Mantra on Hypertensive Patients

NCT03555344

Sponsor

NMP Medical Research Institute

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

High Blood Pressure

Interventions

Mantra Chikitsa

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 28, 2017Actual

Primary Completion Date

May 15, 2018Actual

Completion Date

May 30, 2018Actual

First Submitted Date

Jun 1, 2018

First Submission Date that Met QC Criteria

Jun 1, 2018

First Posted Date

Jun 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2018

Last Update Posted Date

Jul 17, 2018Actual

Name	Class
Warwick Research Services	OTHER
Swamigal Trust for Vedic Science, India	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mantra Chikitsa	Experimental	Mantra chanting for 15 mins	Other: Mantra Chikitsa
Wait list control	No Intervention	Rest for 15 Mins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mantra Chikitsa	Other	Specific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins.	Mantra Chikitsa

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic Blood Pressure		Change from baseline to half an hour
Diastolic Blood Pressure		Change from baseline to half an hour

Secondary Outcomes

Measure	Description	Time Frame
Supine heart rate (HR)		Change from baseline to half an hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed and stable hypertension
on regular medication

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NMP Medical Research Institute		Jaipur	Rajasthan	302019	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided