<?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>IRCT20250816066868N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-06</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of Melissa officinalis capsules on functional dyspepsia</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of Melissa officinalis capsules on functional dyspepsia: a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>94</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/85741</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To ensure equal and completely random distribution of participants in the groups, the randomization process will be carried out entirely through the online system https://www.sealedenvelope.com. To randomly assign individuals to two groups A and B in a 1:1 ratio, a block randomization method with sizes of 4 and 6 will be used, so that a total of 94 participants will be randomly distributed between the two groups through 13 blocks of 4 and 7 blocks of 6, Blinding description: Patients were randomly assigned to receive either the drug or placebo, which were packaged identically and provided to the researcher after coding (in blocks of four and six). Statistical analysis will be conducted by an individual who is unaware of the intervention groups. Allocation concealment   has also been maintained.</study_design>
      <phase>3</phase>
      <hc_freetext>Functional dyspepsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:: A capsule containing 500 mg of lemon balm powder, taken twice a day after meals, for a duration of 4 weeks. Intervention 2: Control group: Capsule containing 500 mg of Avicel, twice a day after meals, for a duration of 4 weeks.</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 No additional information is available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Batool Heydari Yazdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.149, Noufel Lushato 14/1</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177643735</zip>
        <telephone>+98 51 3879 0642</telephone>
        <email>heidarib1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Mahjoub</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Assistant Professor, MD, Ph.D, Department of Persian medicine, School of Persian and complementary medicine, Mashhad University of Medical Sciences, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177899191</zip>
        <telephone>+98 51 3884 8932</telephone>
        <email>mahjoubf@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals with functional dyspepsia (according to Rome IV criteria) who have completed the informed consent form and meet the inclusion criteria without meeting the exclusion criteria will be included in the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with organic digestive disorders include: peptic ulcer, malignancies of the digestive tract, gallbladder-related pain, celiac disease, chronic pancreatitis, Crohn's disease, eosinophilic gastroenteritis, infiltrative stomach diseases (such as sarcoidosis, lymphoma, and amyloidosis), as well as metabolic disorders, hypercalcemia, heavy metal poisoning, gastroparesis, diabetic radiculopathy, parasites (Giardia, Strongyloides), hepatomegaly, and pregnant and breastfeeding mothers, hypothyroidism.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Functional dyspepsia</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:: A capsule containing 500 mg of lemon balm powder, taken twice a day after meals, for a duration of 4 weeks.</i_keyword>
      <i_keyword>Control group: Capsule containing 500 mg of Avicel, twice a day after meals, for a duration of 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity score of dyspeptic symptoms. Timepoint: 4 times: upon arrival, after 2, 4, and 8 weeks. Method of measurement: GIS Dyspepsia Symptom Severity Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: 3 times: upon arrival, after 4 and 8 weeks. Method of measurement: Quality of Life Questionnaire in Dyspepsia (NDI).</sec_outcome>
      <sec_outcome>Symptoms of depression and anxiety. Timepoint: 4 times: upon arrival, after 2, 4, and 8 weeks. Method of measurement: Hamilton Depression and Anxiety Questionnaire.</sec_outcome>
      <sec_outcome>General temperamental symptoms. Timepoint: At the beginning of the study and week 4. Method of measurement: Doctor Mojahidi's temperament questionnaire.</sec_outcome>
      <sec_outcome>Symptoms of stomach disorders. Timepoint: At the beginning of the study and week 4. Method of measurement: Stomach temperament questionnaire by Dr. Hosseinzadeh.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-14</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>No.149 ,Nofel Loshato 14/1 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
