Clinical trial NCT03304938: Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
Official title: Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Sleep Disturbance
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.

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

Primary outcomes:
measure: Pittsburgh Insomnia Rating Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Fasting Blood Sugar
timeFrame: 4 week
measure: 2 hours Post Prandial Glucose
timeFrame: 4 week
measure: Serum Insulin
timeFrame: 4 week
measure: C Reactive Protein
timeFrame: 4 week
measure: Uric acid
timeFrame: 4 week
measure: Creatinine
timeFrame: 4 week
measure: Triglyceride
timeFrame: 4 week
measure: Cholesterol
timeFrame: 4 week
measure: Low Density Lipoprotein
timeFrame: 4 week
measure: High Density Lipoprotein
timeFrame: 4 week
measure: Aspartate Aminotransferase
timeFrame: 4 week
measure: Alanine Aminotransferase
timeFrame: 4 week
measure: weight
timeFrame: 4 week
measure: Body Mass Index
timeFrame: 4 week
measure: waist circumference
timeFrame: 4 week
measure: hip circumference
timeFrame: 4 week
measure: Systolic Blood Pressure
timeFrame: 4 week
measure: Diastolic Blood Pressure
timeFrame: 4 week
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shahid Motahhari Clinic, Shiraz University of Medical Sciences
state: Fars
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Sciences
state: Fars
Study officials:
affiliation: Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
name: Mesbah Shams, M.D.
role: STUDY_CHAIR
References: