<?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>IRCT20221105056400N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-04</date_registration>
      <primary_sponsor>Zanjan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Honey and Trigonella foenum of copd</public_title>
      <acronym></acronym>
      <scientific_title>Investigation of the Honey and the Trigonella foenum-graceum L (fenugreek) ‎seeds product effect on chronic obstructive pulmonary Disease: Double – Blinded ‎Trial‏ ‏</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>81</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: ُSimple randomizationDue to the double-blindness of the study, the doctor, student, and patient will not know about the coding. And the codes are kept with the analyzer and the code given to each patient will be recorded on the patient information registration for, Blinding description: Direction of Double blind study، doctor medical، student and patient dont know of cods.</study_design>
      <phase>3</phase>
      <hc_freetext>Cronic Obstructive Pulmonary Deasese.</hc_freetext>
      <i_freetext>Intervention group:: Patients will be divided into three groups of 27 people and one group will receive placebo and the second group will receive honey syrup and the third group will receive a combination of honey and fenugreek products for 4 weeks. Fenugreek syrup products and Honey and honey syrup will be prepared at the Faculty of Pharmacy of Zanjan University of Medical Sciences and after checking and verifying the quality of herbal ingredients and honey and chemical and microbial stability, the products will be prescribed to patients.The product of fenugreek and honey will be standardized by checking the amount of total saponin based on the active substance Diosgenin. Patients are given a daily amount of syrup containing the extract obtained from 5 grams of fenugreek powder in 2 A divided dose will be prescribed. According to previous studies, the amount of honey will be 40 grams of honey per 100 ml in honey and fenugreek syrup, and honey and placebo syrup will be based on 40 grams of sweetener per 100 ml..</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:
All data cannot be shared after de-identifying individuals, but part of the information related to the main outcome can be shared

When:
Start accessing results 6 months later

To whom:
Researchers working in academic and scientific institutions and people in the pharmaceutical industry

Conditions:
in order to study students and researchers, especially in the field of herbal medicines and traditional pharmaceuticals, under research-oriented conditions and to continue studies in the field of traditional medicine and other valid fields in the field of health and medicine.

Where to obtain:
My email, mobile number

How to obtain:
Six months later, the article was published

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Parisa Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Above Valiasr Square, Valiasr Medical Training Center, Traditional Medicine Clinic</address>
        <city>زنجان</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45157-77978</zip>
        <telephone>+98 24 3377 0801</telephone>
        <email>Parisa.jafari.1349@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dِr Parisa JAFARI</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Above Valiasr North Square, Valiasr Hospital</address>
        <city>Zanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>45157-77978</zip>
        <telephone>+98 24 3377 0801</telephone>
        <email>Parisa.jafari.1349@gmail.com</email>
        <affiliation>Zanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Moderate COPD Deasese diagnosed with Pulmonologist
Deasese with stable condition
Deasese  age 30-60
deasese with self consent</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Deasese with Diabet Melitos
Deasese with  Alergy   Honey and Trigonella foenum
Deasese  with Pregnancy or  Lactation
Deasese   with  sever  COPD
Deasese    with  Underlying deasese such as CF.Heart Failre.Pulmonal Amboly.Ressistant HTN
Deasese    with  Pulmonal  canser  or  other cansers</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>j44.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>j44.1</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:: Patients will be divided into three groups of 27 people and one group will receive placebo and the second group will receive honey syrup and the third group will receive a combination of honey and fenugreek products for 4 weeks. Fenugreek syrup products and Honey and honey syrup will be prepared at the Faculty of Pharmacy of Zanjan University of Medical Sciences and after checking and verifying the quality of herbal ingredients and honey and chemical and microbial stability, the products will be prescribed to patients.The product of fenugreek and honey will be standardized by checking the amount of total saponin based on the active substance Diosgenin. Patients are given a daily amount of syrup containing the extract obtained from 5 grams of fenugreek powder in 2 A divided dose will be prescribed. According to previous studies, the amount of honey will be 40 grams of honey per 100 ml in honey and fenugreek syrup, and honey and placebo syrup will be based on 40 grams of sweetener per 100 ml.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease score based on reliability of chronic obstructive pulmonary disease(cat). Timepoint: Clinical examination and reliability of the disease at the beginning of the study (before intervention) 7, 14 and 21 and after consuming fenugreek and honey syrup at the end of the stud. Method of measurement: Reliability questionnaire of chronic obstructive pulmonary disease( cat ) and spirometry.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The secondary outcome is the improvement of activity dyspnea and energy level and sleep. Timepoint: Before starting the study, on the 7th, 14th, 21st, and then, take fenugreek and honey syrup. Method of measurement: Reliability standard guidelines for chronic obstructive pulmonary diseases (cat).</sec_outcome>
      <sec_outcome>The secondary outcome is the improvement of activity dyspnea and energy level and sleep. Timepoint: Before starting the study, on the 7th, 14th, 21st, and then, take fenugreek and honey syrup. Method of measurement: Reliability standard guidelines for chronic obstructive pulmonary diseases (cat).</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>Research and Technology of Zanjan University of Medical Sciences (Dr. Samad Nedri)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-02</approval_date>
        <contact_name>IR.ZUMS.REC.1401.220</contact_name>
        <contact_address>Blvd. of Ostad Saboti, Zanjan University of Medical Sciences Zanjan Zanjan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
