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Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia (LavenAromDM)

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ClinicalTrials.gov Identifier: NCT03304938
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mesbah Shams, MD, Shiraz University of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Sleep Disturbance Drug: Lavender Oil Drug: Placebos Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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.
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.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lavender oil Drug: Lavender Oil
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
Placebo Comparator: vehicle (Almond oil) Drug: Placebos
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


Outcome Measures
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Primary Outcome Measures :
  1. Pittsburgh Insomnia Rating Scale [ Time Frame: 4 weeks ]
    evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale


Secondary Outcome Measures :
  1. Fasting Blood Sugar [ Time Frame: 4 week ]
    blood sample

  2. 2 hours Post Prandial Glucose [ Time Frame: 4 week ]
    blood sample

  3. Serum Insulin [ Time Frame: 4 week ]
    blood sample

  4. C Reactive Protein [ Time Frame: 4 week ]
    blood sample

  5. Uric acid [ Time Frame: 4 week ]
    blood sample

  6. Creatinine [ Time Frame: 4 week ]
    blood sample

  7. Triglyceride [ Time Frame: 4 week ]
    blood sample

  8. Cholesterol [ Time Frame: 4 week ]
    blood sample

  9. Low Density Lipoprotein [ Time Frame: 4 week ]
    blood sample

  10. High Density Lipoprotein [ Time Frame: 4 week ]
    blood sample

  11. Aspartate Aminotransferase [ Time Frame: 4 week ]
    blood sample

  12. Alanine Aminotransferase [ Time Frame: 4 week ]
    blood sample

  13. weight [ Time Frame: 4 week ]
    Scale

  14. Body Mass Index [ Time Frame: 4 week ]
    Body Mass Index

  15. waist circumference [ Time Frame: 4 week ]
    Meter

  16. hip circumference [ Time Frame: 4 week ]
    Meter

  17. Systolic Blood Pressure [ Time Frame: 4 week ]
    Blood Pressure measurement by digital sphygmometer

  18. Diastolic Blood Pressure [ Time Frame: 4 week ]
    Blood Pressure measurement by digital sphygmometer


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus type 2
  • Age between 25-65 years old
  • Fasting Blood Sugar between 70-130
  • 2 hour post prandial glucose less than 180.
  • HbA1C less than 7
  • Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.

Exclusion Criteria:

  • Any systemic illnesses
  • Use of sedative or antidepressant drugs
  • Pregnancy
  • Lactation
  • History of allergic reaction to Lavender
  • History of allergic rhinitis, asthma and respiratory disorders
  • Anosmia
  • Headache that start with smell
  • Cigarette smocking or substance abuse
  • Hospitalization or surgery within 1 months ago.
  • Work shift
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304938


Locations
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Iran, Islamic Republic of
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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Study Chair: Mesbah Shams, M.D. Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
More Information
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Responsible Party: Mesbah Shams, MD, Associate professor of internal medicine and endocrinology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03304938    
Other Study ID Numbers: 95010112052
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Diabetes Mellitus, Type 2
Sleep Wake Disorders
Nervous System Diseases
 Mental Disorders
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases