<?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>IRCT20230103057033N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-10</date_registration>
      <primary_sponsor>Muhammad Institute of Medical and Allied Sciences, Multan</primary_sponsor>
      <public_title>Therapeutic deep tissue foot  massage with or without jasmine oil in diabetic and hypertensive patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparative effects of therapeutic deep tissue foot  massage with or without jasmine oil in diabetic and hypertensive patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>393</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67831</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Simple randomization. We used sealed envelops for lotterty method and randomization of participants was done. Randomization of participants in groups by lottery method and statistical analysis without biasness, Blinding description: Double blinded study was done by keeping blind i-e the physiotherapist as Investigator and data analyser.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Condition 1: Diabetes Mellitus. Condition 2: Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Treated with jasmine oil.Diabetics and hypertensive patients will receive therapeutic deep tissue foot massage with jasmine oil. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again. Intervention 2: Intervention group: Treated with electrical massager and jasmine oil. Therapeutic deep tissue foot massage with jasmine oil manually , electric  palm massager with jasmine oil, and electric palm massager without jasmine oil  will be applied in diabetics and hypertensive patients. Blood glucose level will be monitored by glucometer of patients (Diabetics and Hypertensive) by pin-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again. Intervention 3: Intervention group: Treated with electrical massager without jasmine oil.electric palm massager without jasmine oil  will be applied in diabetics and hypertensive patients. Blood glucose level will be monitored by glucometer of patients (Diabetics and Hypertensive) by pin-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maliha Khalid Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>142</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 316 6484756</telephone>
        <email>DrMalihatareen@mimas.edu.pk</email>
        <affiliation>Muhammad Institute od Medical and Allied Sciences, Multan.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>142</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 333 6120602</telephone>
        <email>imranahmadkhandurrani@gmail.com</email>
        <affiliation>Muhammad Institute of Medical and Allied Sciences, Multan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age group of 25-70 years
Both Genders  (Male, Female)
Hypertensive patients
Married and unmarried
Educated and uneducated
Diabetic patients</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any type of mental disability
Lactating females
Having any type of physical disability
History of chest pain, bronchitis, asthma, angina, MI
Chronic illness related to cardiorespiratory ailments
Any type  of major surgery•
Pregnant females</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E08</hc_code>
      <hc_code>I15.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus due to underlying condition with diabetic chronic kidney disease</hc_keyword>
      <hc_keyword>Secondary hypertension, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Treated with jasmine oil.Diabetics and hypertensive patients will receive therapeutic deep tissue foot massage with jasmine oil. A glucometer will be used to monitor blood glucose levels in patients (both diabetic and hypertensive) via finger-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.</i_keyword>
      <i_keyword>Intervention group: Treated with electrical massager and jasmine oil. Therapeutic deep tissue foot massage with jasmine oil manually , electric  palm massager with jasmine oil, and electric palm massager without jasmine oil  will be applied in diabetics and hypertensive patients. Blood glucose level will be monitored by glucometer of patients (Diabetics and Hypertensive) by pin-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.</i_keyword>
      <i_keyword>Intervention group: Treated with electrical massager without jasmine oil.electric palm massager without jasmine oil  will be applied in diabetics and hypertensive patients. Blood glucose level will be monitored by glucometer of patients (Diabetics and Hypertensive) by pin-prick testing. And blood pressure, blood cholesterol (lipid profile), oxygen saturation and temperature also monitored and body mass index (height, weight, body fat) of both diabetics and hypertensive patients before massage and after massage will be measured. After fifteen consecutive days all these parameters will be measured again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Increase in Blood circulation and insulin secretion in diabetic patients. Timepoint: 3 weeks. Method of measurement: Blood glucose level by glucometer.</prim_outcome>
      <prim_outcome>Mean arterial pressure. Timepoint: 3 weeks. Method of measurement: Mercury manometer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: 3 weeks. Method of measurement: Heart rate measuring device.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: 3 weeks. Method of measurement: pulse oximeter.</prim_outcome>
      <prim_outcome>Respiration rate. Timepoint: 3 weeks. Method of measurement: manually.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Increase in blood circulation. Timepoint: 3 weeks. Method of measurement: Devices.</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>Institutional Funding policy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-11</approval_date>
        <contact_name>Muhammad Institute of Medical and Allied Sciences Multan</contact_name>
        <contact_address>No. 142, Multan Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
