<?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>IRCT2016041927477N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-03</date_registration>
      <primary_sponsor>Vice chancellor for research, Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of therapeutic models of Traditional Persian Medicine  on overweight</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the efficacy of therapeutic packeges  in Traditional Medicine (diet and product medicine based on Persian Traditional Medicine) with classical Medicine (diet  based on Classical Medicine and Venustat ) In weight loss overweight patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22498</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Overwieght.</hc_freetext>
      <i_freetext>Intervention 1: First group: Control: Venustat:  120 mg  cap: 3 cap per day for three months + Standard diet Classical Medicine  for three months. (The calorie consumption is equivalent in three groups.). Intervention 2: Group 3: Second Intervention: Traditional Persian Medicine model: Traditional Persian Medicine diet. (The calorie consumption is  equivalant  in three groups.) + Dava Balgham. (Medicinal product based on  zattaria Multiflora and Nigella Sativa، Mastic and Carum Capticum ) 5 gr 2 per day morning fasting and night before sleep for three  month.    m. Intervention 3: Group 2: First Intervention: Classical Medicine diet.(The calorie consumption is equivalant in three groups) + Dava balgham (Medicinal product based on zattaria multiflora and Nigella sativa and Mastic and Carum capticum ) 5 gr 2 per day morning fasting and night before sleep for three months.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Liely Hamidnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Razi street</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3855 2189</telephone>
        <email>hamidniaL911@mums.ac.irdr.hamidnia@yahoo.com</email>
        <affiliation>School of Persian and Complementary medicine of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Motevasselian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>East Razi street</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 3855 2188</telephone>
        <email>motavasselian@mums.ac.ir</email>
        <affiliation>School of Persian and Complementary medicine of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria : َAge 18 to 60 years؛ BMI 27 to 29/9 (Kg / m2)؛ Waist circumference greater than 88 cm  - Exclusion criteria : Patients with diabetes and high blood pressure to used medicine؛  Chronic diseases of the liver؛ Chronic failure of kidney؛ Heavy smoker more than 20 cigarettes per day؛ Obesity caused by metabolic disorders؛  Familial obesity؛ Pregnancy؛ Lactation؛ AIDS and Hepatitis؛ Cancer؛ Obese patients referred to clinics in the last 6 months؛ Patients with body composition   fat and water lesser than muscle based on   Bioelectrical impedance analyzer؛ A history of intolerance or allergy  to honey, thyme, mastic , capticum and Nigella sativa .</inclusion_criteria>
      <agemin>77 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E65-E68</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity and other hyperalimentation</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>First group: Control: Venustat:  120 mg  cap: 3 cap per day for three months + Standard diet Classical Medicine  for three months. (The calorie consumption is equivalent in three groups.)</i_keyword>
      <i_keyword>Group 3: Second Intervention: Traditional Persian Medicine model: Traditional Persian Medicine diet. (The calorie consumption is  equivalant  in three groups.) + Dava Balgham. (Medicinal product based on  zattaria Multiflora and Nigella Sativa، Mastic and Carum Capticum ) 5 gr 2 per day morning fasting and night before sleep for three  month.    m.</i_keyword>
      <i_keyword>Group 2: First Intervention: Classical Medicine diet.(The calorie consumption is equivalant in three groups) + Dava balgham (Medicinal product based on zattaria multiflora and Nigella sativa and Mastic and Carum capticum ) 5 gr 2 per day morning fasting and night before sleep for three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body max Index. Timepoint: Before intervention then every two weeks until the end of the intervention. Method of measurement: By (Body Composition Analyzer System) model Tanita.</prim_outcome>
      <prim_outcome>Body Composition. Timepoint: Before intervention and three months after intervention. Method of measurement: Body Composition Analyzer System model tanita.</prim_outcome>
      <prim_outcome>Basal Metabolism Rate. Timepoint: Before intervention and three months after intervention. Method of measurement: By Indirect calorimetry SETُ.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fast LDL. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum  LDL concentration in mg/dl.</sec_outcome>
      <sec_outcome>Fast HDL. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum  HDL concentration in mg/dl.</sec_outcome>
      <sec_outcome>Fast Blood sugar. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum sugar concentration in mg/dl.</sec_outcome>
      <sec_outcome>Fast Cholesterol. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum Cholesterol concentration in mg/dl.</sec_outcome>
      <sec_outcome>Fast TG. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum TG concentration in mg/dl.</sec_outcome>
      <sec_outcome>Fast SGOT، SGPT، ALKP. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum  SGOT .SGPT .ALKP concentration in unit/lit.</sec_outcome>
      <sec_outcome>Thyroid hormones (T3 .T4 .TSH). Timepoint: Before intervention and three months after intervention. Method of measurement: Serum Thyroid hormones concentration  in ng/ml.</sec_outcome>
      <sec_outcome>Fe serum concentration. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum  Fe concentration in micg/dl.</sec_outcome>
      <sec_outcome>Zn serum concentraiton. Timepoint: Before intervention and three months after intervention. Method of measurement: Fasting serum  Zn concentration in micg/dl.</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>Vice chancellor for research, Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-06-20</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad, University Avenue, Building Qureshi ZIP Code: 345-91375 Phone: 5-38412081 051 051 38411538 Fax: 051 38430249 E-mail: vcresearch@mums.ac.i Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
