Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia (LavenAromDM)
Primary Purpose
Diabetes Mellitus, Type 2, Sleep Disturbance
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lavender Oil
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- Shahid Motahhari Clinic, Shiraz University of Medical Sciences
- Shiraz University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Lavender oil
vehicle (Almond oil)
Arm Description
Outcomes
Primary Outcome Measures
Pittsburgh Insomnia Rating Scale
evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
Secondary Outcome Measures
Fasting Blood Sugar
blood sample
2 hours Post Prandial Glucose
blood sample
Serum Insulin
blood sample
C Reactive Protein
blood sample
Uric acid
blood sample
Creatinine
blood sample
Triglyceride
blood sample
Cholesterol
blood sample
Low Density Lipoprotein
blood sample
High Density Lipoprotein
blood sample
Aspartate Aminotransferase
blood sample
Alanine Aminotransferase
blood sample
weight
Scale
Body Mass Index
Body Mass Index
waist circumference
Meter
hip circumference
Meter
Systolic Blood Pressure
Blood Pressure measurement by digital sphygmometer
Diastolic Blood Pressure
Blood Pressure measurement by digital sphygmometer
Full Information
NCT ID
NCT03304938
First Posted
July 25, 2017
Last Updated
April 4, 2019
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03304938
Brief Title
Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
Acronym
LavenAromDM
Official Title
Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender oil
Arm Type
Active Comparator
Arm Title
vehicle (Almond oil)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lavender Oil
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention 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
Primary Outcome Measure Information:
Title
Pittsburgh Insomnia Rating Scale
Description
evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Fasting Blood Sugar
Description
blood sample
Time Frame
4 week
Title
2 hours Post Prandial Glucose
Description
blood sample
Time Frame
4 week
Title
Serum Insulin
Description
blood sample
Time Frame
4 week
Title
C Reactive Protein
Description
blood sample
Time Frame
4 week
Title
Uric acid
Description
blood sample
Time Frame
4 week
Title
Creatinine
Description
blood sample
Time Frame
4 week
Title
Triglyceride
Description
blood sample
Time Frame
4 week
Title
Cholesterol
Description
blood sample
Time Frame
4 week
Title
Low Density Lipoprotein
Description
blood sample
Time Frame
4 week
Title
High Density Lipoprotein
Description
blood sample
Time Frame
4 week
Title
Aspartate Aminotransferase
Description
blood sample
Time Frame
4 week
Title
Alanine Aminotransferase
Description
blood sample
Time Frame
4 week
Title
weight
Description
Scale
Time Frame
4 week
Title
Body Mass Index
Description
Body Mass Index
Time Frame
4 week
Title
waist circumference
Description
Meter
Time Frame
4 week
Title
hip circumference
Description
Meter
Time Frame
4 week
Title
Systolic Blood Pressure
Description
Blood Pressure measurement by digital sphygmometer
Time Frame
4 week
Title
Diastolic Blood Pressure
Description
Blood Pressure measurement by digital sphygmometer
Time Frame
4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mesbah Shams, M.D.
Organizational Affiliation
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
Facility Name
Shiraz University of Medical Sciences
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
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