xml: <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/NCT06015919</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/003872</org_study_id>
      <nct_id>NCT06015919</nct_id>
    </id_info>
    <brief_title>Effect of Dash Diet and Acupuncture on Hypertention in Postmenopausal Women</brief_title>
    <official_title>Effect of Dash Diet and Acupuncture on Hypertention in Postmenopausal Women</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>faculty of physical therapy</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cairo University</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>
        A study of effect of dash diet and acupuncture on hypertension in postmenopausal women&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        45 of post menopausal women divided into three groups A,B,C&#xD;
  &#xD;
          -  Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and&#xD;
             anti-hypertensive drugs.&#xD;
  &#xD;
          -  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture&#xD;
             and anti-hypertensive drugs.&#xD;
  &#xD;
          -  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet,&#xD;
             acupuncture and anti-hypertensive drugs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 5, 2022</start_date>
    <completion_date type="Actual">August 20, 2023</completion_date>
    <primary_completion_date type="Actual">April 25, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>dash diet and acupuncture on post menopausal hypertention</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>blood pressure</measure>
      <time_frame>3 months</time_frame>
      <description>it will be measured by sphygmomanometer pre and post treatment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>sodium and potassium levels</measure>
      <time_frame>3 months</time_frame>
      <description>it will be measured by blood analysis pre and post treatment</description>
    </secondary_outcome>
    <other_outcome>
      <measure>assessment of quality of life</measure>
      <time_frame>3 months</time_frame>
      <description>it will be measured by sf 36 questionnaire pre and post treatment</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Postmenopausal Disorder</condition>
    <arm_group>
      <arm_group_label>effect of dash diet and acupuncture on hypertention in post menopausal women</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.&#xD;
  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.&#xD;
  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>dash diet</intervention_name>
      <description>Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.&#xD;
  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.&#xD;
  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.</description>
      <arm_group_label>effect of dash diet and acupuncture on hypertention in post menopausal women</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Acupuncture</intervention_name>
      <description>acupuncture</description>
      <arm_group_label>effect of dash diet and acupuncture on hypertention in post menopausal women</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Their body mass index will be ranged from 25 -29.9 kg/m2&#xD;
  &#xD;
            -  All patients will be medically stable when attending the study.&#xD;
  &#xD;
            -  The DASH eating plan of 1800 kcal per day will be used in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Auditory and visual problems.&#xD;
  &#xD;
            -  Chronic renal failure.&#xD;
  &#xD;
            -  Myocardial infarction or arrythmias with heart failure.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>post menopausal hypertensive women</gender_description>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alaa Nabil Elsayed Mohamed</name>
        <address>
          <city>Abu hammad</city>
          <state>Elsharqia</state>
          <zip>44661</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Alaa Nabil Elsayed Mohamed</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015919
  org study id: P.T.REC/012/003872
  nct id: NCT06015919
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A study of effect of dash diet and acupuncture on hypertension in postmenopausal women
  45 of post menopausal women divided into three groups A,B,C
  
          -  Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and
             anti-hypertensive drugs.
  
          -  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture
             and anti-hypertensive drugs.
  
          -  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet,
             acupuncture and anti-hypertensive drugs.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: dash diet and acupuncture on post menopausal hypertention
  primary purpose: Treatment
  masking: None (Open Label)
  measure: blood pressure
  time frame: 3 months
  description: it will be measured by sphygmomanometer pre and post treatment
  measure: sodium and potassium levels
  time frame: 3 months
  description: it will be measured by blood analysis pre and post treatment
  measure: assessment of quality of life
  time frame: 3 months
  description: it will be measured by sf 36 questionnaire pre and post treatment
  arm group label: effect of dash diet and acupuncture on hypertention in post menopausal women
  arm group type: Experimental
  description: Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.
  intervention type: Behavioral
  intervention name: dash diet
  description: Group (A): It will include 15 post-menopausal women who will be treated by DASH diet and anti-hypertensive drugs.
  Group (B): It will include 15 post-menopausal women who will be treated by acupuncture and anti-hypertensive drugs.
  Group (C): It will include 15 post-menopausal women who will be treated by DASH diet, acupuncture and anti-hypertensive drugs.
  arm group label: effect of dash diet and acupuncture on hypertention in post menopausal women
  intervention type: Device
  intervention name: Acupuncture
  description: acupuncture
  arm group label: effect of dash diet and acupuncture on hypertention in post menopausal women
  criteria: 
  gender: Female
  gender based: Yes
  gender description: post menopausal hypertensive women
  minimum age: 50 Years
  maximum age: 60 Years
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Alaa Nabil Elsayed Mohamed
  investigator title: principal investigator