<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817827</url>
  </required_header>
  <id_info>
    <org_study_id>123</org_study_id>
    <nct_id>NCT03817827</nct_id>
  </id_info>
  <brief_title>Effect of Acupuncture and Diet Modification on amenorrheaIN FEMALE ATHLETE TRIAD</brief_title>
  <official_title>Effect of Acupuncture and Diet Modification on Amenorrhea in Female Athlete Triad</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Centre, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Research Centre, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study will be designed to investigate the effect of acupuncture and diet&#xD;
      modification using soy products on amenorrhea in female athlete triad.&#xD;
&#xD;
      For this purpose this study will be carried out on sixty female athletes participating&#xD;
      gymnastics. They will be recruited from Sports Medicine specialized center in Nasr City,&#xD;
      their ages will range from 17 to 25 years old and their BMI will be &lt; 20 Kg/m2 .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will be divided into three groups equal in number, matched for measured&#xD;
      variable:&#xD;
&#xD;
      Group (A): Acupuncture only will be used in this group for 30 minutes, three times per week&#xD;
      for twelve weeks. The acupuncture needles were inserted in points located on the abdomen.&#xD;
&#xD;
      Group (B): This group will receive only the diet modification contains soy products&#xD;
      (phytoestrogen) as 100 milliliter soy milk and 100 grams soy beans daily in the morning as a&#xD;
      breakfast alone to ensure its absorption, this dose had been taken for 12 weeks.&#xD;
&#xD;
      Group (C): This group will receive both acupuncture therapy for 30 minutes, three times per&#xD;
      week for 12 weeks and diet modification contains soy products as 100 milliliter soy milk and&#xD;
      100 grams soy beans daily in the morning for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The trial was delayed and patient recruitment was deemed high-risk during the Covid-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">May 5, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>follicle stimulating hormone</measure>
    <time_frame>three months</time_frame>
    <description>Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Luteinizing hormone</measure>
    <time_frame>three months</time_frame>
    <description>Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>estradiol 2</measure>
    <time_frame>three months</time_frame>
    <description>Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Female Athlete Triad</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group will receive Acupuncture therapy for 30 minutes three times per week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>diet modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group will receive diet using soy products a</description>
  </arm_group>
  <arm_group>
    <arm_group_label>combined group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>will receive both acupuncture therapy and soy products</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>this group will receive Acupuncture for 30 minutes three times per week</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>combined group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Diet supplementary</intervention_name>
    <description>Diet supplementary with soy product</description>
    <arm_group_label>combined group</arm_group_label>
    <arm_group_label>diet modification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients suffering from athletic amenorrhea.&#xD;
&#xD;
          -  Their age will be ranged from 17-25 years old.&#xD;
&#xD;
          -  Their body mass index will be less than 18.5 kg/m2.&#xD;
&#xD;
          -  No history of previous pregnancies.&#xD;
&#xD;
          -  No history of any pathological disease causing amenorrhea.&#xD;
&#xD;
          -  They are medically stable and consented to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with gynecological diseases that may cause amenorrhea.&#xD;
&#xD;
          -  Patients using contraceptive pills.&#xD;
&#xD;
          -  Patients using hormonal treatment.&#xD;
&#xD;
          -  Patients using induction of ovulation methods.&#xD;
&#xD;
          -  Patients following any other diet modification method.&#xD;
&#xD;
          -  Patients who receive any drug with side effect of amenorrhea.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sports medicine speciaized center</name>
      <address>
        <city>Cairo</city>
        <state>Nasr City</state>
        <zip>46374</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Research Centre, Egypt</investigator_affiliation>
    <investigator_full_name>Amr Hazim Abbassy</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>sports injury</keyword>
  <keyword>female athlete triad</keyword>
  <keyword>acupuncture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Female Athlete Triad Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817827
org study id: 123
nct id: NCT03817827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study will be designed to investigate the effect of acupuncture and diet
      modification using soy products on amenorrhea in female athlete triad.

      For this purpose this study will be carried out on sixty female athletes participating
      gymnastics. They will be recruited from Sports Medicine specialized center in Nasr City,
      their ages will range from 17 to 25 years old and their BMI will be < 20 Kg/m2 .
The subjects will be divided into three groups equal in number, matched for measured
      variable:

      Group (A): Acupuncture only will be used in this group for 30 minutes, three times per week
      for twelve weeks. The acupuncture needles were inserted in points located on the abdomen.

      Group (B): This group will receive only the diet modification contains soy products
      (phytoestrogen) as 100 milliliter soy milk and 100 grams soy beans daily in the morning as a
      breakfast alone to ensure its absorption, this dose had been taken for 12 weeks.

      Group (C): This group will receive both acupuncture therapy for 30 minutes, three times per
      week for 12 weeks and diet modification contains soy products as 100 milliliter soy milk and
      100 grams soy beans daily in the morning for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: follicle stimulating hormone
time frame: three months
description: Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer
measure: Luteinizing hormone
time frame: three months
description: Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer
measure: estradiol 2
time frame: three months
description: Blood sample will be taken from the patient at the beginning of the study and three months later to determine the change of hormone level using Immulite 1000 immunoassay analyzer
arm group label: Acupuncture
arm group type: Experimental
description: this group will receive Acupuncture therapy for 30 minutes three times per week
arm group label: diet modification
arm group type: Experimental
description: this group will receive diet using soy products a
arm group label: combined group
arm group type: Experimental
description: will receive both acupuncture therapy and soy products
intervention type: Other
intervention name: Acupuncture
description: this group will receive Acupuncture for 30 minutes three times per week
arm group label: Acupuncture
arm group label: combined group
intervention type: Dietary Supplement
intervention name: Diet supplementary
description: Diet supplementary with soy product
arm group label: combined group
arm group label: diet modification
criteria: 
gender: Female
gender based: Yes
minimum age: 17 Years
maximum age: 25 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: National Research Centre, Egypt
investigator full name: Amr Hazim Abbassy
investigator title: Lecturer
mesh term: Female Athlete Triad Syndrome