<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03803306</url>
  </required_header>
  <id_info>
    <org_study_id>NMP 2172</org_study_id>
    <nct_id>NCT03803306</nct_id>
  </id_info>
  <brief_title>Vedic Medical Astrology in Essential Hypertension</brief_title>
  <official_title>Vedic Medical Astrology in Essential Hypertension: A Double-blind, Placebo-controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Warwick Research Services (UK) Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Swamigal Trust for Vedic Science, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NMP Medical Research Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Previous studies have explored the correlation and impact of astrological events in relation&#xD;
      of diseases, health concerns and relationship between birth chart and disease risk.&#xD;
      Cardiovascular conditions, sleep and fertility were found significantly associated with moon&#xD;
      phase. However, to best of our knowledge no study has documented the impact of astrological&#xD;
      intervention in disease management.&#xD;
&#xD;
      This is a randomised, multi-center, double blind placebo controlled clinical trial with two&#xD;
      parallel arms. This trial aims to evaluate the effectiveness of Vedic medical astrological&#xD;
      intervention for patients with mild to moderate hypertension,with respect to decreasing their&#xD;
      blood pressure and improving their quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2018</start_date>
  <completion_date type="Actual">January 6, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average systolic and average diastolic blood pressure</measure>
    <time_frame>change from baseline to 12-weeks</time_frame>
    <description>Blood pressure measured by 24-hour ambulatory blood pressure monitoring</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in patients Quality of life</measure>
    <time_frame>change from baseline to 12-weeks</time_frame>
    <description>Health-related quality of life measure by S36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Essential Hypertension</condition>
  <arm_group>
    <arm_group_label>Vedic Medical Astrology Group (VMA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo vedic medical astrology (PMA)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Vedic Medical Astrology</intervention_name>
    <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</description>
    <arm_group_label>Vedic Medical Astrology Group (VMA)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo vedic medical astrology (PMA)</intervention_name>
    <description>Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.</description>
    <arm_group_label>Placebo vedic medical astrology (PMA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients age between 35 and 60 years old, male and female;&#xD;
&#xD;
          -  Patients who meet the diagnostic criteria of essential hypertension (&#xD;
&#xD;
          -  Patients taking antihypertensive drugs under the supervision of physicians.&#xD;
&#xD;
          -  Patients having understanding of our study and willing to comply with astrological&#xD;
             protocol.&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have been diagnosed as secondary hypertension or malignant hypertension&#xD;
&#xD;
          -  Patients with comorbid conditions&#xD;
&#xD;
          -  Patients with a chronic disease associated or psychiatric conditions which might not&#xD;
             suitable for the study&#xD;
&#xD;
          -  Patients who had been treated with any other alternative or complementary medicine&#xD;
             during the previous three months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Sharma, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Warwick Research Services (UK) Ltd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Prashanna Chockalingam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Warwick Research Services (UK) Ltd</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Puneet Sharma</last_name>
    <role>Study Chair</role>
    <affiliation>NMP Medical Research Institute, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ramanathan Ravisankar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Swamigal Trust for Vedic Science, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMP Medical Reserach Institute</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03803306
org study id: NMP 2172
nct id: NCT03803306
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Average systolic and average diastolic blood pressure
time frame: change from baseline to 12-weeks
description: Blood pressure measured by 24-hour ambulatory blood pressure monitoring
measure: Changes in patients Quality of life
time frame: change from baseline to 12-weeks
description: Health-related quality of life measure by S36
arm group label: Vedic Medical Astrology Group (VMA)
arm group type: Experimental
arm group label: Placebo vedic medical astrology (PMA)
arm group type: Sham Comparator
intervention type: Combination Product
intervention name: Vedic Medical Astrology
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
arm group label: Vedic Medical Astrology Group (VMA)
intervention type: Other
intervention name: Placebo vedic medical astrology (PMA)
description: Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.
arm group label: Placebo vedic medical astrology (PMA)
criteria: 
gender: All
minimum age: 35 Years
maximum age: 60 Years
healthy volunteers: No
last name: Neha Sharma, PhD
role: Study Director
affiliation: Warwick Research Services (UK) Ltd
last name: Prashanna Chockalingam
role: Principal Investigator
affiliation: Warwick Research Services (UK) Ltd
last name: Puneet Sharma
role: Study Chair
affiliation: NMP Medical Research Institute, India
last name: Ramanathan Ravisankar
role: Principal Investigator
affiliation: Swamigal Trust for Vedic Science, India
facility: 
country: India
responsible party type: Sponsor
mesh term: Hypertension
mesh term: Essential Hypertension
sharing ipd: Undecided