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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Sleep Disturbance

Intervention / Treatment
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* Drug: Lavender Oil
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lavender oil<br> | Drug: Lavender Oil<br>* 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<br>|
| Placebo Comparator: vehicle (Almond oil)<br> | Drug: Placebos<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Insomnia Rating Scale | evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Sugar | blood sample | 4 week | 
| 2 hours Post Prandial Glucose | blood sample | 4 week | 
| Serum Insulin | blood sample | 4 week | 
| C Reactive Protein | blood sample | 4 week | 
| Uric acid | blood sample | 4 week | 
| Creatinine | blood sample | 4 week | 
| Triglyceride | blood sample | 4 week | 
| Cholesterol | blood sample | 4 week | 
| Low Density Lipoprotein | blood sample | 4 week | 
| High Density Lipoprotein | blood sample | 4 week | 
| Aspartate Aminotransferase | blood sample | 4 week | 
| Alanine Aminotransferase | blood sample | 4 week | 
| weight | Scale | 4 week | 
| Body Mass Index | Body Mass Index | 4 week | 
| waist circumference | Meter | 4 week | 
| hip circumference | Meter | 4 week | 
| Systolic Blood Pressure | Blood Pressure measurement by digital sphygmometer | 4 week | 
| Diastolic Blood Pressure | Blood Pressure measurement by digital sphygmometer | 4 week |