<?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>IRCT20130911014630N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-16</date_registration>
      <primary_sponsor>Mazandaran University of Medical Science- Sari - Mazandaran - Iran</primary_sponsor>
      <public_title>Evaluation of Gel Formulation of Trigonella foenum-graceum Seed on prevention of trichoptilosis in randomized placebo controlled Clinical Trial</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Gel Formulation of Trigonella foenum-graceum Seed on prevention of trichoptilosis in randomized placebo controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14212</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, individual, using random numbers table, Blinding description: In this study, dermatologist, and dermatologist, as well as the placebo or drug product, have no information about the product and the products have been pre - determined and randomly assigned to the patients.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Trichoptilosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The gel contains 5 grams extract of seeds of fenugreek  used Twice daily  , so that the whole hair should be covered . Do not shave 12 hours after use .To this end, 30 patients are selected according to the conditions of entry.They are given the drug gel formulation containing fenugreek seed extract for two months under the supervision of a dermatologist and in collaboration with the presenter.Herbal gel contains 5% fenugreek seed extract.To prepare 100 cc of gel, 0.02 grams of propyl paraben, 0.18 grams of methyl paraben, 1 gram of carbapl 980, 5 milliliters of glycerin, Small amount of 1% NaOH solutionn and up to 100 cc of distilled water, UP is used. It is expected that the extract of Fenugreek seed with its effect on the cuticle structure of the hair will increase its strength and reduce the bulging of the ends of hair shafts. This gel was made in the lab of the Mazandaran -Sari Pharmaceutical Faculty. Intervention 2: Control group: The placebo gel contains all the ingredients of the drug gel except for the fenugreek seed extract.The method of use is the same as druged gel. It is used twice daily and Do not shave 12 hours after use.To this end, 30 patients are selected according to the conditions of entry.They are given the placebo gel formulation for two months under the supervision of a dermatologist and in collaboration with the presenter.It is expected that this gel does not have a significant effect, unlike the  druged gel.This gel was made at the laboratory of the Mazandaran -Sari Pharmaceutical Faculty.</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:
Results from clinical trials

When:
Start access after printing the article

To whom:
Access for scholars working in academic institutions

Conditions:
Use of results is allowed only by mentioning its source

Where to obtain:
azadbakhtm@hotmail.com

How to obtain:
Request from the researcher

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Hajizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacy College - Payambar Azam Medicinal Complex - Sari - Mazandaran - Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>00</telephone>
        <email>Majidhajizadeh_72@Yahoo.com</email>
        <affiliation>Mazandaran University of Medicinal Science-Sari- Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Azadbakht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pharmacy College - Payambar Azam Medicinal Complex- Sari -Mazandaran -Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>00</telephone>
        <email>Mazadbakht@Mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Science-Sari</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Age 20-50
Man or woman
Selection of patients without prior knowledge and based on their referral to a specialist physician
The patient has an impairment trichoptilosis
The patient has a disorder of personal satisfaction with the use of the product</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>L67.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other hair colour and Hair shaft abnormalities</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The gel contains 5 grams extract of seeds of fenugreek  used Twice daily  , so that the whole hair should be covered . Do not shave 12 hours after use .To this end, 30 patients are selected according to the conditions of entry.They are given the drug gel formulation containing fenugreek seed extract for two months under the supervision of a dermatologist and in collaboration with the presenter.Herbal gel contains 5% fenugreek seed extract.To prepare 100 cc of gel, 0.02 grams of propyl paraben, 0.18 grams of methyl paraben, 1 gram of carbapl 980, 5 milliliters of glycerin, Small amount of 1% NaOH solutionn and up to 100 cc of distilled water, UP is used. It is expected that the extract of Fenugreek seed with its effect on the cuticle structure of the hair will increase its strength and reduce the bulging of the ends of hair shafts. This gel was made in the lab of the Mazandaran -Sari Pharmaceutical Faculty.</i_keyword>
      <i_keyword>Control group: The placebo gel contains all the ingredients of the drug gel except for the fenugreek seed extract.The method of use is the same as druged gel. It is used twice daily and Do not shave 12 hours after use.To this end, 30 patients are selected according to the conditions of entry.They are given the placebo gel formulation for two months under the supervision of a dermatologist and in collaboration with the presenter.It is expected that this gel does not have a significant effect, unlike the  druged gel.This gel was made at the laboratory of the Mazandaran -Sari Pharmaceutical Faculty.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Trichoptilosis. Timepoint: At least 2 times in week along 2 month. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Calvities. Timepoint: At least 2 times in week along 2 month. Method of measurement: Questinnaire.</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>Mazandaran University of Medical Science- Sari - Mazandaran - Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics Commitee of Mazandaran University Of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences - Sari Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
