<?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>IRCT20231129060218N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-21</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Ginseng herbal medicine on the sexual Function</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of ginseng herbal medicine on the sexual Function of patients with diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74285</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization process in the present study will involve using sealed envelopes. Initially, a random sequence of numbers will be generated. Subsequently, a corresponding number of envelopes lined with aluminum foil will be prepared based on the research sample size. Each of the created random sequences will be transcribed onto a card, with the cards then being placed inside the envelopes in sequential order. Finally, the envelopes will be sealed and placed in a box according to their order. Upon participant registration, an envelope will be opened based on the entry sequence of eligible participants, revealing the assigned group for that participant, Blinding description: Initially, all patients received a thorough and comprehensive explanation of the study's objectives. Clear and detailed explanations about the intervention type and the effects of ginseng were provided to all patients. Subsequently, as patients will be allocated to either the control or intervention groups based on a specific code, they will be kept unaware of their assignment to the intervention or control group, in contrast to receiving a placebo or ginseng herbal medicine. Announcements will be made. Caregivers at the patient's bedside will be informed by the investigators, and both the data collector and data analyst will be kept unaware of the grouping.</study_design>
      <phase>3</phase>
      <hc_freetext>Sexual function of in diabetic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: recipient of ginseng capsules, containing 100 mg of ginseng, prepared by Dana company, two capsules per day, for 8 weeks. Intervention 2: Control group: Placebo capsule recipient, two capsules per day, for 8 weeks, the placebo will be prepared by the researchers using the empty capsule, size number 1, and wheat flour.</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 further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Rahami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saheli park _ yasuj university medical sience</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591846667</zip>
        <telephone>+98 74 3333 7251</telephone>
        <email>zahra.rahami@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Rahami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Saheli park _ yasuj university medical sience</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591846667</zip>
        <telephone>+98 74 3333 7251</telephone>
        <email>zahra.rahami@yums.ac.ir</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Heterosexual men and women aged 35 to 55
Who have been sexually active for at least 6 months
Who will be sexually active in the next 8 weeks
Who will obtain approval score score on the relevant sexual dysfunction questionnaire</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any physical disability that can limit sexual function
Receiving any treatment for any sexual disorder in the past 6 months
Prescribing Coumadin, warfarin, heparin, dalteparin, enoxaparin, or any other anticoagulant therapy
Prescribing levodopa for Parkinson's disease or calciputerin for psoriasis
Diagnosing high blood pressure and prescribing antihypertensive drugs
Severe renal or hepatic failure
Anatomical anomalies of the reproductive system
Uncontrolled diabetes mellitus
History of spinal cord injury
Uncontrolled sexual secondary mental disorders
Diagnosed prostate cancer or benign hypertrophy
History of genital surgery
History of chronic alcohol or drug abuse
Suspected or diagnosed allergy to ginseng
Participation in any other clinical trial in the past 30 days</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sexual dysfunction not due to a substance or known physiological condition</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: recipient of ginseng capsules, containing 100 mg of ginseng, prepared by Dana company, two capsules per day, for 8 weeks.</i_keyword>
      <i_keyword>Control group: Placebo capsule recipient, two capsules per day, for 8 weeks, the placebo will be prepared by the researchers using the empty capsule, size number 1, and wheat flour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Women's orgasmic performance scores. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Premature ejaculation performance of patients. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The international index of erectile function (IIEF).</prim_outcome>
      <prim_outcome>Sexual desire/arousal. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The international index of erectile function (IIEF) and Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Erectile dysfunction scores of patients. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The international index of erectile function (IIEF) and Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Delayed ejaculation scores. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: The international index of erectile function (IIEF) and Female Sexual Function Index (FSFI).</prim_outcome>
      <prim_outcome>Determination of LDL, HDL, testosterone, prolactin and HBA1C levels. Timepoint: Before intervention and 8 weeks after intervention. Method of measurement: Calibrated laboratory instruments.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-01</approval_date>
        <contact_name>Ethics committee of yasuj university of medical science</contact_name>
        <contact_address>Saheli street_ yasuj university of medical science Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
