<?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>IRCT20200826048534N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-12</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Lavandula Officinalis in treatment of diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Study of the Effect of Hydroalcholic Extract of Lavandula Officinalis on Some Biochemical Factors in Blood and Urine in  Diabetes.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50586</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A total of 80 diabetic patients referred to Imam Ali Clinic in Shahrekord according to the number of patients referred (diagnosis number) and grouping A and B (which was not clear to patients and the person responsible for patient selection , which group of drugs and which placebo) through Random Allocaton statistical software related to simple randomization method was obtained and entered into each of the relevant groups (with random numbers Computer software that divided the numbers 1 to 80 into simple groups A and B by simple randomization. It was determined which number of patient be in which group A or B.), Blinding description: None of the patients knew in which group (drug or control) they were.
The person responsible for patient selection was also unaware of which of A or B group was the drug or placebo group.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 40 diabetic patients who, in addition to routine medications used by diabetic patients (Metformin, Glibenclamide), received 2, 500 mg capsules containing Lavender extract daily, 2 times in the morning and at night. Intervention 2: Control group: 40 diabetic patients who, in addition to routine medications(Metformin,Glibenclamide) used by diabetic patients, received 2 placebo capsules twice daily before meals.</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 more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Mahmudnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord, Rahmatieh, Shahrekord University of Medical Sciences</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158166356</zip>
        <telephone>+98 38 3333 9940</telephone>
        <email>mahmudnia.L@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Mahmudnia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrekord, Rahmatieh, Shahrekord University of Medical Sciences</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8158166356</zip>
        <telephone>+98 38 3333 9940</telephone>
        <email>mahmudnia.L@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of  diabetes
Patients aged 30 to 60 years
Fasting blood sugar  ≥126 mg / dl
Intravenous blood serum glucose 200 mg/dl, 2 hours after ingestion of 75 g of oral glucose
Not receiving insulin
HbA1C from 7 to 8.5 
Diagnosis of diabetes is less than 10 years
Use only oral antihyperglycemic drugs(Metformin,Glibenclamide)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Smoking
Chronic Cardiovascular Diseases
Chronic Kidney Disease
Triglycerides more than 500
Pregnancy 
Taking Anticoagulants (except Aspirin) 
Chronic Liver Diseases except Fatty Liver 
Advanced Diabetic Retinopathy 
Kidney Failure 
Heart Failure 
Hemorrhagic Stroke</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E14</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 40 diabetic patients who, in addition to routine medications used by diabetic patients (Metformin, Glibenclamide), received 2, 500 mg capsules containing Lavender extract daily, 2 times in the morning and at night.</i_keyword>
      <i_keyword>Control group: 40 diabetic patients who, in addition to routine medications(Metformin,Glibenclamide) used by diabetic patients, received 2 placebo capsules twice daily before meals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fasting blood sugar. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>HbA1C. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Cholestrol. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Very low density lipoprotein. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Low density lipoprotein. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>High density lipoprotein. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Alanine transaminase. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Blood urea nitrogen. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With special kits by an autoanalyzer system.</prim_outcome>
      <prim_outcome>Urine sugar. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With urine strip dip stick.</prim_outcome>
      <prim_outcome>Urine protein. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: With urine strip dip stick.</prim_outcome>
      <prim_outcome>Body mass index. Timepoint: At the beginning of the study  and 2 months after consumption of drugs. Method of measurement: It was measured and calculated with a tape measure and Ska scale (weight in kilograms divided by height to the power of 2 in square meters).</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-05-26</approval_date>
        <contact_name>Ethics committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Shahrekord, Kashani Blvd., University Headquarters, Building No. 2 Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
