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Vedic Medical Astrology in Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803306
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
Warwick Research Services (UK) Ltd
Swamigal Trust for Vedic Science, India
Information provided by (Responsible Party):
NMP Medical Research Institute

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.


Condition or disease Intervention/treatment Phase
Essential Hypertension Combination Product: Vedic Medical Astrology Other: Placebo vedic medical astrology (PMA) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Vedic Medical Astrology in Essential Hypertension: A Double-blind, Placebo-controlled Study
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : January 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vedic Medical Astrology Group (VMA) 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

Sham Comparator: Placebo vedic medical astrology (PMA) Other: Placebo vedic medical astrology (PMA)
Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.




Primary Outcome Measures :
  1. Average systolic and average diastolic blood pressure [ Time Frame: change from baseline to 12-weeks ]
    Blood pressure measured by 24-hour ambulatory blood pressure monitoring


Secondary Outcome Measures :
  1. Changes in patients Quality of life [ Time Frame: change from baseline to 12-weeks ]
    Health-related quality of life measure by S36



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803306


Locations
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India
NMP Medical Reserach Institute
Jaipur, Rajasthan, India
Sponsors and Collaborators
NMP Medical Research Institute
Warwick Research Services (UK) Ltd
Swamigal Trust for Vedic Science, India
Investigators
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Study Director: Neha Sharma, PhD Warwick Research Services (UK) Ltd
Principal Investigator: Prashanna Chockalingam Warwick Research Services (UK) Ltd
Study Chair: Puneet Sharma NMP Medical Research Institute, India
Principal Investigator: Ramanathan Ravisankar Swamigal Trust for Vedic Science, India
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Responsible Party: NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT03803306    
Other Study ID Numbers: NMP 2172
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases