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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender oil | Active Comparator |
| |
| vehicle (Almond oil) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Insomnia Rating Scale | evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Sugar | blood sample | 4 week |
| 2 hours Post Prandial Glucose | blood sample | 4 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mesbah Shams, M.D. | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Motahhari Clinic, Shiraz University of Medical Sciences | Shiraz | Fars | Iran | |||
| Shiraz University of Medical Sciences |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C045718 | lavender oil |
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40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups.
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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.
| 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 |
|
| 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 |
| Shiraz |
| Fars |
| Iran |
| D004700 | Endocrine System Diseases |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |