<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20160808029264N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-12</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Electro Acupuncture and Laser Acupuncture in the treatment of patients with mild high blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Electro Acupuncture and Laser Acupuncture in the treatment of patients with mild high blood pressure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69529</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization method: sealed envelopes and numbers 1 to 30 are written on each paper, and then each envelope is assigned to one person by lottery and numbers 1, 4, 7 and ... so on. belong to the first group and the numbers 2 5 8 and... to the second group and the numbers 3 6 9 and ... They belong to the third group, Blinding description: Only the person responsible for blood pressure measurement is unaware of the grouping of people.</study_design>
      <phase>N/A</phase>
      <hc_freetext>high blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Applying electroacupuncture in the form of 2 sessions a week for 4 weeks, each session will last 30 minutes, and during this period, 10 needles will be inserted in points LR3, ST36, PC6, PC5, and LI11, and electric current with a frequency of 2 Hz and an intensity of 2 mA will be established by SDZ II device. Intervention 2: Intervention group: Applying laser acupuncture in the form of 2 sessions a week for 4 weeks, each session will last 30 minutes, and during this time, the low-power laser will be placed on the LR3, ST36, PC6, PC5, and LI11 points. These points are bilaterally on the body, and the 500 milliwatt laser will be placed on each point for 3 minutes. Intervention 3: Control group: Taking medicines that are already taken by the patient and no change or intervention will happen.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
It will be published as an article

When:
It will be published as an article

To whom:
-

Conditions:
-

Where to obtain:
It will be published as an article

How to obtain:
It will be published as an article

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamidreza Alibabaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasteur Square, Western Pastor St., Agideh St., Guderzi Alley, Cambys Dead End, No. 2, Unit 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1318845581</zip>
        <telephone>+98 21 6659 4170</telephone>
        <email>hamiddd.reza1378@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamidreza Alibabaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pastor Square - Western Pastor St. - Agideh St. - Guderzi Alley - Cambys Dead End - No. 2 - Unit 2</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1318845581</zip>
        <telephone>+98 21 6659 4170</telephone>
        <email>hamiddd.reza1378@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with mild hypertension (stage 1) , i.e., systolic blood pressure between 140 and 159 mmHg and diastolic blood pressure between 90 and 99 mmHg
have been receiving medical treatment for hypertension for more than one year</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a habit of physical activity or special diet such as yoga, meditation, auriculotherapy, acupuncture, etc.
Taking more than one type of blood pressure medicine per day
patients with high blood pressure secondary to other diseases
receiving acupuncture treatment in the last month</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Applying electroacupuncture in the form of 2 sessions a week for 4 weeks, each session will last 30 minutes, and during this period, 10 needles will be inserted in points LR3, ST36, PC6, PC5, and LI11, and electric current with a frequency of 2 Hz and an intensity of 2 mA will be established by SDZ II device.</i_keyword>
      <i_keyword>Intervention group: Applying laser acupuncture in the form of 2 sessions a week for 4 weeks, each session will last 30 minutes, and during this time, the low-power laser will be placed on the LR3, ST36, PC6, PC5, and LI11 points. These points are bilaterally on the body, and the 500 milliwatt laser will be placed on each point for 3 minutes.</i_keyword>
      <i_keyword>Control group: Taking medicines that are already taken by the patient and no change or intervention will happen.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic and diastolic blood pressure. Timepoint: Before the intervention - before the first session - after the first session - at the end of 8 sessions - one month follow-up. Method of measurement: Digital blood pressure measuring device - 24-hour blood pressure holter device.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before the intervention - before the first session - after the first session - at the end of 8 sessions - one month follow-up. Method of measurement: Digital blood pressure measuring device - 24-hour blood pressure holter device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-13</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Pasteur Square, Western Pastor St., Ajideh St., Gudarzi Alley, Kambiz Dead End, No. 2, Unit 2 Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
