An interventional study of Lavender Oil and Placebos in Diabetes Mellitus, Type 2 and Sleep Disturbance, sponsored by Shiraz University of Medical Sciences. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by Shiraz University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Drug: Lavender Oil
Drug: Placebos
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
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
Pittsburgh Insomnia Rating Scale
evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
Time frame: 4 weeks
Fasting Blood Sugar
blood sample
Time frame: 4 week
2 hours Post Prandial Glucose
blood sample
Time frame: 4 week
Serum Insulin
blood sample
Time frame: 4 week
C Reactive Protein
blood sample
Time frame: 4 week
Uric acid
blood sample
Time frame: 4 week
Creatinine
blood sample
Time frame: 4 week
Triglyceride
blood sample
Time frame: 4 week
Cholesterol
blood sample
Time frame: 4 week
Low Density Lipoprotein
blood sample
Time frame: 4 week
High Density Lipoprotein
blood sample
Time frame: 4 week
Aspartate Aminotransferase
blood sample
Time frame: 4 week
Alanine Aminotransferase
blood sample
Time frame: 4 week
weight
Scale
Time frame: 4 week
Body Mass Index
Body Mass Index
Time frame: 4 week
waist circumference
Meter
Time frame: 4 week
hip circumference
Meter
Time frame: 4 week
Systolic Blood Pressure
Blood Pressure measurement by digital sphygmometer
Time frame: 4 week
Diastolic Blood Pressure
Blood Pressure measurement by digital sphygmometer
Time frame: 4 week
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Shiraz University of Medical Sciences