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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03803306
Other study ID # NMP 2172
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 12, 2018
Est. completion date January 6, 2019

Study information

Verified date January 2019
Source NMP Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date January 6, 2019
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
Vedic Medical Astrology
Individualised astrological based interventions were given including vedic counselling, diet, colors, gems, mantras and the worship deities as an adjuvent to ongoing conventional treatments
Other:
Placebo vedic medical astrology (PMA)
Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.

Locations

Country Name City State
India NMP Medical Reserach Institute Jaipur Rajasthan

Sponsors (3)

Lead Sponsor Collaborator
NMP Medical Research Institute Swamigal Trust for Vedic Science, India, Warwick Research Services (UK) Ltd

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average systolic and average diastolic blood pressure Blood pressure measured by 24-hour ambulatory blood pressure monitoring change from baseline to 12-weeks
Secondary Changes in patients Quality of life Health-related quality of life measure by S36 change from baseline to 12-weeks
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