<?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>IRCT20190219042768N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-10</date_registration>
      <primary_sponsor>Tarbiat modares univecity</primary_sponsor>
      <public_title>Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling  in the female population</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of jujube and turmeric extract on serum adiponectin, sexual function and estradiol hormones profiling  in the female population</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37666</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Simple randomization of an individual with an envelope in dividing the groups into two groups A and B. In this method, we selected a number of cards or letters as the intervention group and the same number of cards for the control group, then merged the cards together. One card was taken out and its allocation was recorded, and after the card was taken out, we returned it again to all the other cards. Then the cards are merged again and we take out another card. This process continues until a random sequence is reached according to the sample size, Blinding description: The present study is a triple-blind study and the researcher and the patient and analyst will be unaware of the treatment and grouping of the study. For this purpose, turmeric extract and placebo are encoded by another person. The main researcher intervenes patients in a triple-blind manner based on the code of drug packages. The drug code is recorded on the demographic information completion form. Intervention in the target group will be turmeric extract for 8 weeks at a rate of 300 kg / mg Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 8 weeks after using turmeric extract, again in women of both groups A venous blood sample will be taken.</study_design>
      <phase>1-2</phase>
      <hc_freetext>sexual dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  treatment  with turmeric extract will be 300 mg  for 4 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran. Intervention 2: Control group:  treatment by placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 4 weeks after using , women in both groups will have venous blood sampling again.</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:
Only part of the information

When:
Access period starts 6 months after the results are published

To whom:
Scientific and research studies

Conditions:
With sample permission

Where to obtain:
E-mail

How to obtain:
Ethics Committee. Investigation proceedings

Comments:
One week to one month</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Tehrnian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal al Ahmad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1383657631</zip>
        <telephone>+98 21 6660 9606</telephone>
        <email>tehranian@modares.ac.ir</email>
        <affiliation>Tarbiat Modares university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Faraz Mojab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jalal al ahmad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1383657631</zip>
        <telephone>+98 21 6660 9606</telephone>
        <email>sfmojab@sbmu.ac.ir</email>
        <affiliation>Tarbiat Modares univesity</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>be Persian and Farsi
Married and currently lives with her husband
Not currently pregnant or have child  breastfeeding
dont be Infertile
dont have any Abortion and delivery of cesarean section
There is no history of medical problems such as diabetes and hypertension, psychological diseases, hip infections, pelvic pathological and other medical problems.
her contraceptive methods are not hormonal.
Over the past three months, they have not used drugs that interfere with sexual function.
have Normal BMI (between 18.9 and 24.9)
No use of special diets like vegetarianism
Poor sexual function according to the FSFI questionnaire
Moderate to severe stress levels based on the DOS questionnaire</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>good sexual function
Mild stress</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other 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:  treatment  with turmeric extract will be 300 mg  for 4 weeks. This article has been extracted and concentrated by Dr. Elaheh Sadeghi under the supervision of Dr. Mohsen Sharifi, Professor, Department of Plant Physiology, Faculty of Basic Sciences, Tarbiat Modarres University, Iran</i_keyword>
      <i_keyword>Control group:  treatment by placebo, Placebo will be prepared in a similar way to turmeric extract without its effective ingredients. 4 weeks after using , women in both groups will have venous blood sampling again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sexual dysfunction. Timepoint: before and after intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Steroidal hormones. Timepoint: before and after intervention. Method of measurement: laboratory kits.</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>Tarbiat modares univecity</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-01-12</approval_date>
        <contact_name>Ethics Committee of tarbiat modares university</contact_name>
        <contact_address>jalal alahmad tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
