High Blood PressureNCT03555344
Effect of Mantra on Hypertensive Patients
A study testing Mantra Chikitsa in people with High Blood Pressure, run by NMP Medical Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- High Blood Pressure
- What is being tested?
- Mantra Chikitsa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIndia
- Study dates
- 28 Oct 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed and stable hypertension
- on regular medication
Who cannot join
- Individuals diagnosed with another lung disease,
- Have psychiatric, musculoskeletal or cardiovascular diseases,
- Being smokers
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Mantra Chikitsa on Cardiovascular Parameters in Hypertensive Patients
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.
- Conditions
- High Blood Pressure
- Being tested
- Mantra Chikitsa
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mantra ChikitsaOther
Also called Mantra therapy
Specific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins.
| Study group | Role | What they receive |
|---|---|---|
| Mantra Chikitsa | Experimental | Mantra chanting for 15 mins Receives: Other: Mantra Chikitsa |
| Wait list control | No intervention | Rest for 15 Mins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: Change from baseline to half an hour
Diastolic Blood Pressure
Measured: Change from baseline to half an hour
Secondary outcomes (1)
Supine heart rate (HR)
Measured: Change from baseline to half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start28 Oct 2017
- Primary completion15 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Swamigal Trust for Vedic Science, India
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, PhD, Study director, Warwick Research ServicesRavishankar Ramanathan, Principal investigator, Swamigal Trust for Vedic Science, IndiaPuneet Sharma, Study chair, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555344
- Sponsor's protocol ID
- NMP/10164
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Mantra Chikitsa on Cardiovascular Parameters in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03555344
- Acronym / sponsor ID
- NMP/10164
- Conditions
- High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Swamigal Trust for Vedic Science, India
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 13 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mantra Chikitsa | Experimental | Other: Mantra ChikitsaMantra chanting for 15 mins |
| Wait list control | No intervention | –Rest for 15 Mins |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed and stable hypertension
- on regular medication
Key exclusion criteria (4 listed)
- Individuals diagnosed with another lung disease,
- Have psychiatric, musculoskeletal or cardiovascular diseases,
- Being smokers
- Being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mantra ChikitsaAlso: Mantra therapySpecific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins. | Other | Mantra Chikitsa |
Primary outcome
Systolic Blood Pressure
Time frame: Change from baseline to half an hour
Diastolic Blood Pressure
Time frame: Change from baseline to half an hour
1 secondary outcome
Supine heart rate (HR)
Time frame: Change from baseline to half an hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, PhD study director
Warwick Research Services
Ravishankar Ramanathan principal investigator
Swamigal Trust for Vedic Science, India
Puneet Sharma study chair
NMP Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mantra Chikitsa in people with High Blood Pressure, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Change from baseline to half an hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.