NCT03803306

Brief Summary

Previous studies have explored the correlation and impact of astrological events in relation of diseases, health concerns and relationship between birth chart and disease risk. Cardiovascular conditions, sleep and fertility were found significantly associated with moon phase. However, to best of our knowledge no study has documented the impact of astrological intervention in disease management. This is a randomised, multi-center, double blind placebo controlled clinical trial with two parallel arms. This trial aims to evaluate the effectiveness of Vedic medical astrological intervention for patients with mild to moderate hypertension,with respect to decreasing their blood pressure and improving their quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

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

July 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

January 11, 2019

Last Update Submit

January 11, 2019

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Average systolic and average diastolic blood pressure

    Blood pressure measured by 24-hour ambulatory blood pressure monitoring

    change from baseline to 12-weeks

Secondary Outcomes (1)

  • Changes in patients Quality of life

    change from baseline to 12-weeks

Study Arms (2)

Vedic Medical Astrology Group (VMA)

EXPERIMENTAL
Combination Product: Vedic Medical Astrology

Placebo vedic medical astrology (PMA)

SHAM COMPARATOR
Other: Placebo vedic medical astrology (PMA)

Interventions

Vedic Medical AstrologyCOMBINATION_PRODUCT

Individualised astrological based interventions were given including vedic counselling, diet, colors, gems, mantras and the worship deities as an adjuvent to ongoing conventional treatments

Vedic Medical Astrology Group (VMA)
Placebo vedic medical astrology (PMA)OTHER

Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.

Placebo vedic medical astrology (PMA)

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients age between 35 and 60 years old, male and female;
  • Patients who meet the diagnostic criteria of essential hypertension (
  • Patients taking antihypertensive drugs under the supervision of physicians.
  • Patients having understanding of our study and willing to comply with astrological protocol.
  • Informed consent

You may not qualify if:

  • Patients who have been diagnosed as secondary hypertension or malignant hypertension
  • Patients with comorbid conditions
  • Patients with a chronic disease associated or psychiatric conditions which might not suitable for the study
  • Patients who had been treated with any other alternative or complementary medicine during the previous three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Reserach Institute

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Neha Sharma, PhD

    Warwick Research Services (UK) Ltd

    STUDY DIRECTOR

  • Prashanna Chockalingam

    Warwick Research Services (UK) Ltd

    PRINCIPAL INVESTIGATOR

  • Puneet Sharma

    NMP Medical Research Institute, India

    STUDY CHAIR

  • Ramanathan Ravisankar

    Swamigal Trust for Vedic Science, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2019

First Posted

January 14, 2019

Study Start

July 12, 2018

Primary Completion

December 15, 2018

Study Completion

January 6, 2019

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

IN(1)