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NCT Number: NCT03304938

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

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shahid Motahhari Clinic, Shiraz University of Medical Sciences, Shiraz, Fars, Iran

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavender Oil

Drug

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

Placebos

Drug

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

Primary outcomes

  1. Pittsburgh Insomnia Rating Scale

    Time frame: 4 weeks

    evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia

Acronym: LavenAromDM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 9, 2017
Registry last updated
Apr 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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