<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/NCT03304938</url>
  </required_header>
  <id_info>
    <org_study_id>95010112052</org_study_id>
    <nct_id>NCT03304938</nct_id>
  </id_info>
  <brief_title>Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia</brief_title>
  <acronym>LavenAromDM</acronym>
  <official_title>Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shiraz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shiraz University of Medical Sciences</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>
      This study is designed as cross-over double-blind placebo-controlled randomized clinical&#xD;
      trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter&#xD;
      into the study and randomly assign to first intervention and first placebo groups.The primary&#xD;
      outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the&#xD;
      end of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Considering the high prevalence of sleep disturbance in diabetic patients and the&#xD;
      effectiveness of lavender in treatment of sleep disorders in this study the efficacy of&#xD;
      Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be&#xD;
      investigated. This study is designed as cross-over double-blind placebo-controlled randomized&#xD;
      clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will&#xD;
      enter into the study and randomly assign to first intervention and first placebo groups.The&#xD;
      primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated&#xD;
      at the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</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>Crossover Assignment</intervention_model>
    <intervention_model_description>40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Lavender Essential oil as medication and almond oil as placebo put in similar dark buttle and the head of placebo bottle aromatized whit Lavender Essential oil and all of participants, care provider, investigator and outcomes assessor will be blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pittsburgh Insomnia Rating Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting Blood Sugar</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2 hours Post Prandial Glucose</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Insulin</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C Reactive Protein</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uric acid</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low Density Lipoprotein</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High Density Lipoprotein</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate Aminotransferase</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine Aminotransferase</measure>
    <time_frame>4 week</time_frame>
    <description>blood sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight</measure>
    <time_frame>4 week</time_frame>
    <description>Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>4 week</time_frame>
    <description>Body Mass Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>waist circumference</measure>
    <time_frame>4 week</time_frame>
    <description>Meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hip circumference</measure>
    <time_frame>4 week</time_frame>
    <description>Meter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic Blood Pressure</measure>
    <time_frame>4 week</time_frame>
    <description>Blood Pressure measurement by digital sphygmometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic Blood Pressure</measure>
    <time_frame>4 week</time_frame>
    <description>Blood Pressure measurement by digital sphygmometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Sleep Disturbance</condition>
  <arm_group>
    <arm_group_label>Lavender oil</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>vehicle (Almond oil)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lavender Oil</intervention_name>
    <description>The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks</description>
    <arm_group_label>Lavender oil</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks</description>
    <arm_group_label>vehicle (Almond oil)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus type 2&#xD;
&#xD;
          -  Age between 25-65 years old&#xD;
&#xD;
          -  Fasting Blood Sugar between 70-130&#xD;
&#xD;
          -  2 hour post prandial glucose less than 180.&#xD;
&#xD;
          -  HbA1C less than 7&#xD;
&#xD;
          -  Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic illnesses&#xD;
&#xD;
          -  Use of sedative or antidepressant drugs&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Lactation&#xD;
&#xD;
          -  History of allergic reaction to Lavender&#xD;
&#xD;
          -  History of allergic rhinitis, asthma and respiratory disorders&#xD;
&#xD;
          -  Anosmia&#xD;
&#xD;
          -  Headache that start with smell&#xD;
&#xD;
          -  Cigarette smocking or substance abuse&#xD;
&#xD;
          -  Hospitalization or surgery within 1 months ago.&#xD;
&#xD;
          -  Work shift&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mesbah Shams, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shahid Motahhari Clinic, Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <state>Fars</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiraz University of Medical Sciences</name>
      <address>
        <city>Shiraz</city>
        <state>Fars</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shiraz University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Mesbah Shams, MD</investigator_full_name>
    <investigator_title>Associate professor of internal medicine and endocrinology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT03304938
org study id: 95010112052
nct id: NCT03304938
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is designed as cross-over double-blind placebo-controlled randomized clinical
      trial that 40 diabetic patients with sleep disorder with the inclusion criteria will enter
      into the study and randomly assign to first intervention and first placebo groups.The primary
      outcomes are change in sleep disorder and metabolic parameters that will be evaluated at the
      end of the study.
Considering the high prevalence of sleep disturbance in diabetic patients and the
      effectiveness of lavender in treatment of sleep disorders in this study the efficacy of
      Lavender aromatherapy in sleep disorder and metabolic parameters in diabetic patients will be
      investigated. This study is designed as cross-over double-blind placebo-controlled randomized
      clinical trial that 40 diabetic patients with sleep disorder with the inclusion criteria will
      enter into the study and randomly assign to first intervention and first placebo groups.The
      primary outcomes are change in sleep disorder and metabolic parameters that will be evaluated
      at the end of the study.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Lavender Essential oil as medication and almond oil as placebo put in similar dark buttle and the head of placebo bottle aromatized whit Lavender Essential oil and all of participants, care provider, investigator and outcomes assessor will be blind.
measure: Pittsburgh Insomnia Rating Scale
time frame: 4 weeks
description: evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
measure: Fasting Blood Sugar
time frame: 4 week
description: blood sample
measure: 2 hours Post Prandial Glucose
time frame: 4 week
description: blood sample
measure: Serum Insulin
time frame: 4 week
description: blood sample
measure: C Reactive Protein
time frame: 4 week
description: blood sample
measure: Uric acid
time frame: 4 week
description: blood sample
measure: Creatinine
time frame: 4 week
description: blood sample
measure: Triglyceride
time frame: 4 week
description: blood sample
measure: Cholesterol
time frame: 4 week
description: blood sample
measure: Low Density Lipoprotein
time frame: 4 week
description: blood sample
measure: High Density Lipoprotein
time frame: 4 week
description: blood sample
measure: Aspartate Aminotransferase
time frame: 4 week
description: blood sample
measure: Alanine Aminotransferase
time frame: 4 week
description: blood sample
measure: weight
time frame: 4 week
description: Scale
measure: Body Mass Index
time frame: 4 week
description: Body Mass Index
measure: waist circumference
time frame: 4 week
description: Meter
measure: hip circumference
time frame: 4 week
description: Meter
measure: Systolic Blood Pressure
time frame: 4 week
description: Blood Pressure measurement by digital sphygmometer
measure: Diastolic Blood Pressure
time frame: 4 week
description: Blood Pressure measurement by digital sphygmometer
arm group label: Lavender oil
arm group type: Active Comparator
arm group label: vehicle (Almond oil)
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Lavender Oil
description: The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks
arm group label: Lavender oil
intervention type: Drug
intervention name: Placebos
description: The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks
arm group label: vehicle (Almond oil)
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mesbah Shams, M.D.
role: Study Chair
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
facility: 
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shiraz University of Medical Sciences
investigator full name: Mesbah Shams, MD
investigator title: Associate professor of internal medicine and endocrinology
mesh term: Dyssomnias
mesh term: Parasomnias
mesh term: Diabetes Mellitus, Type 2