<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/NCT02188225</url>
  </required_header>
  <id_info>
    <org_study_id>GMU.REC.1393.56</org_study_id>
    <nct_id>NCT02188225</nct_id>
  </id_info>
  <brief_title>Comparison of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women</brief_title>
  <official_title>Comparison of the Effects of Acupuncture and Fluoxetine on Quality of Life in Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gonabad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gonabad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on&#xD;
      improvement quality of life among menopausal women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is designed in two arm include acupuncture and fluoxetine group to&#xD;
      evaluate the effect of these intervention on improvement quality of life among menopausal&#xD;
      women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">February 20, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life in menopausal women</measure>
    <time_frame>3 months after start sampling</time_frame>
    <description>Quality of life using MENQOL questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Hot Flash</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fluoxetine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <other_name>Manual acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluoxetine</intervention_name>
    <description>10 mg/ daily</description>
    <arm_group_label>fluoxetine</arm_group_label>
    <other_name>flouxetine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Last menstrual cycle 12 months ago&#xD;
&#xD;
          -  natural menopause&#xD;
&#xD;
          -  4 episodes of hot flash daily&#xD;
&#xD;
          -  follicle stimulating hormone (FSH)= 30-110 IU/L , E2&lt;18pg/ml&#xD;
&#xD;
          -  thyroid-stimulating hormone(TSH)= 0.4-4/0 IU/ml&#xD;
&#xD;
          -  No using of herbal agent for treatment of hot flash&#xD;
&#xD;
          -  having score in Beck depression Inventory&lt;10&#xD;
&#xD;
          -  No existence of any medical problems and using drugs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not completing all acupuncture sessions&#xD;
&#xD;
          -  Not completing fluoxetine admission&#xD;
&#xD;
          -  Withdraw the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Narjes Bahri, PhD Student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gonabad University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gonabad University of Medical Sciences</name>
      <address>
        <city>Gonabad</city>
        <state>Khorasan Razavi</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narjes Bahri</name>
      <address>
        <city>Mashhad</city>
        <state>Razavi Hkorasan Privience</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gonabad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Narjes Bahri</investigator_full_name>
    <investigator_title>Instructor of midwifery education</investigator_title>
  </responsible_party>
  <keyword>Hot flash</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Fluoxetine</keyword>
  <keyword>Quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hot Flashes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluoxetine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02188225
org study id: GMU.REC.1393.56
nct id: NCT02188225
lead sponsor: 
has dmc: Yes
The purpose of this study is to comparison the effect of acupuncture and Fluoxetine on
      improvement quality of life among menopausal women.
This clinical trial is designed in two arm include acupuncture and fluoxetine group to
      evaluate the effect of these intervention on improvement quality of life among menopausal
      women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Quality of life in menopausal women
time frame: 3 months after start sampling
description: Quality of life using MENQOL questionnaire
arm group label: Acupuncture
arm group type: Experimental
description: 12 sessions of acupuncture / 3 sessions weekly/ 20 minutes each session
arm group label: fluoxetine
arm group type: Active Comparator
description: 10 mg daily
intervention type: Procedure
intervention name: acupuncture
description: 12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
arm group label: Acupuncture
other name: Manual acupuncture
intervention type: Drug
intervention name: fluoxetine
description: 10 mg/ daily
arm group label: fluoxetine
other name: flouxetine
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Narjes Bahri, PhD Student
role: Principal Investigator
affiliation: Gonabad University of Medical Sciences
facility: 
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Gonabad University of Medical Sciences
investigator full name: Narjes Bahri
investigator title: Instructor of midwifery education
mesh term: Hot Flashes
mesh term: Fluoxetine
sharing ipd: Undecided