Back to resultsVedic Medical Astrology in Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Vedic Medical Astrology
Placebo vedic medical astrology (PMA)
Sponsored by
About this trial
This is an interventional supportive care trial for Essential Hypertension
Eligibility 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
Sites / Locations
- NMP Medical Reserach Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Vedic Medical Astrology Group (VMA)
Placebo vedic medical astrology (PMA)
Arm Description
Outcomes
Primary Outcome Measures
Average systolic and average diastolic blood pressure
Blood pressure measured by 24-hour ambulatory blood pressure monitoring
Secondary Outcome Measures
Changes in patients Quality of life
Health-related quality of life measure by S36
Full Information
NCT ID
NCT03803306
First Posted
January 11, 2019
Last Updated
January 11, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services (UK) Ltd, Swamigal Trust for Vedic Science, India
1. Study Identification
Unique Protocol Identification Number
NCT03803306
Brief Title
Vedic Medical Astrology in Essential Hypertension
Official Title
Vedic Medical Astrology in Essential Hypertension: A Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 15, 2018 (Actual)
Study Completion Date
January 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services (UK) Ltd, Swamigal Trust for Vedic Science, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vedic Medical Astrology Group (VMA)
Arm Type
Experimental
Arm Title
Placebo vedic medical astrology (PMA)
Arm Type
Sham Comparator
Intervention Type
Combination Product
Intervention Name(s)
Vedic Medical Astrology
Intervention Description
Individualised astrological based interventions were given including vedic counselling, diet, colors, gems, mantras and the worship deities as an adjuvent to ongoing conventional treatments
Intervention Type
Other
Intervention Name(s)
Placebo vedic medical astrology (PMA)
Intervention Description
Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.
Primary Outcome Measure Information:
Title
Average systolic and average diastolic blood pressure
Description
Blood pressure measured by 24-hour ambulatory blood pressure monitoring
Time Frame
change from baseline to 12-weeks
Secondary Outcome Measure Information:
Title
Changes in patients Quality of life
Description
Health-related quality of life measure by S36
Time Frame
change from baseline to 12-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Warwick Research Services (UK) Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Prashanna Chockalingam
Organizational Affiliation
Warwick Research Services (UK) Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Puneet Sharma
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ramanathan Ravisankar
Organizational Affiliation
Swamigal Trust for Vedic Science, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMP Medical Reserach Institute
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vedic Medical Astrology in Essential Hypertension
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