<?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>IRCT20170501033751N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-19</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of combined herbal powder on asthmatic patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of combined herbal powder on the severity of symptoms (couph and dyspnea) and spirometery indexes in patients with asthma</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62322</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be selected based on purpose and will be randomly assigned in two groups of intervention and control by balanced block randomization method, Blinding description: This study will be conducted in a three-blind design so that the participants, physician and treatment team of the respiratory clinic and the researcher based in the clinic will not have information about the allocation of individuals and the type of intervention applied to the participant.After a person who is eligible to participate in the study is introduced to the researcher by the clinic physician, the researcher informs the coordinating center of the relevant person by phone; In the coordinator center, the researcher is assigned based on the order of pre-determined codes and the envelope number that must be given to the person is notified. The number written on the envelopes is a random and irregular three-digit number. These numbers and codes for each person will be kept on confidential forms on the Coordination Center. The team based at the Coordination Center will not have direct contact with the participants and will not interfere in the collection of information and analysis of study data.</study_design>
      <phase>2</phase>
      <hc_freetext>asthma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:500 mg mixed plant powder (containing 1000 mg of ocimum basilicum seeds. 1000 mg of plantago seeds • 1000 mg of plantago ovata forssk seeds • 1000 mg of Salvia macrosiphon seeds • 1000 mg of alyssum alyssoides seeds) orally at a rate of two sachets per day (to For a month). This powder is made by Ghaem Daroo Pharmaceutical Company. Intervention 2: Control group: Consumption of sachets containing 5000 mg of toasted bread powder, which is similar in color and appearance to herbal powder, in the amount of two sachets per day orally (for one month). Placebo powder is made by Ghaem Daroo Pharmaceutical Company.</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 is sharable when unrecognizable

When:
1400

To whom:
all researcher

Conditions:
to related research

Where to obtain:
khomein medical university.Deputy of Education and Research. Mr. Hamid Momeni. Phone number: 08646221534. Fax: 08646224143

How to obtain:
Submit a written request via fax to receive documents to the Vice Chancellor for Education and Research of Khomein School of Medical Sciences and after a maximum of one month, receive information about the research

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>rezvan ghafarzadegan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij square</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881743364</zip>
        <telephone>+98 86 4622 1534</telephone>
        <email>rghafarzadegan@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Momeni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Square</address>
        <city>Khomein</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3881743364</zip>
        <telephone>+98 86 4622 1534</telephone>
        <email>hamid52us@yahoo.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>desire to participate in the study
Age 18 to 65 years
Asthma at the diagnosis of a pulmonologist
Absence of other respiratory diseases including bronchitis, chronic obstructive pulmonary disease</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Evidence of respiratory infection in a recent month
Recent exacerbation of clinical symptoms of asthma
Unwanted side effects of herbal medicine
Reluctance to cooperate in any of the stages of research
Do not use herbal medicine as directed Herbal capsules provided)
Change of standard drugs used by the patient during the study
Perform surgery and general anesthesia during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asthma</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:500 mg mixed plant powder (containing 1000 mg of ocimum basilicum seeds. 1000 mg of plantago seeds • 1000 mg of plantago ovata forssk seeds • 1000 mg of Salvia macrosiphon seeds • 1000 mg of alyssum alyssoides seeds) orally at a rate of two sachets per day (to For a month). This powder is made by Ghaem Daroo Pharmaceutical Company.</i_keyword>
      <i_keyword>Control group: Consumption of sachets containing 5000 mg of toasted bread powder, which is similar in color and appearance to herbal powder, in the amount of two sachets per day orally (for one month). Placebo powder is made by Ghaem Daroo Pharmaceutical Company.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Asthma symptoms and spirometry indicators. Timepoint: Before the intervention and one month after the start of the use of herbal powder. Method of measurement: Using an asthma symptom questionnaire and a spirometer.</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-05</approval_date>
        <contact_name>Ethics Committee of Khomein School of Medical Sciences</contact_name>
        <contact_address>Basij square khomein Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
