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IRCT201703117297N3 IRCT 2017-10-21 Shiraz University of Medical Sciences Efficacy and safety of Lavender aromatherapy on sleep quality and metabolic parameters of patients with diabetes mellitus type II and insomnia Lavender aromatherapy in diabetic patient with sleep disorders Efficacy and safety of Lavender aromatherapy on sleep quality and metabolic parameters of patients with diabetes mellitus type II and insomnia 2017-08-20 anticipated 40 Complete https://irct.ir/trial/7746 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment. N/A diabetes-insomnia. Intervention 1: Lavender Essential oil. Intervention 2: almond oil.
public Dr Mojtaba Heydari
Zand Avenue. Central building Shiraz University of Medical Sciences, Shiraz, Iran.
Shiraz Iran (Islamic Republic of) 71345-1978 +98 71 3235 7282 vcrdep@sums.ac.ir Shiraz University of Medical Sciences scientific Mesbah Shams, M.D.Associate professor of Internal medicine and Endocrinology
zand Av, Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 71345- 1978 +98 71 3235 7282 vcrdep@sums.ac.ir Shams@sums.ac.ir meshkat_114@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:• Age: 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. 25 years 65 years Both Treatment - Drugs Placebo Lavender Essential oil almond oil Pittsburgh Insomnia Rating Scale. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: pittsburgh Insomnia Rating Scale. CRP. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: Blood sample. FBS. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. TG. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. Cholesterol. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. LDL. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. HDL. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. 2hPPG. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. Serum Insulin. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. AST. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. ALT. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: blood sample. Height. Timepoint: before intervention. Method of measurement: meter. Weight. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: weight scale. BMI. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: BMI Index. Waist circumference. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: meter. Hip circumference. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: meter. HbA1C. Timepoint: before intervention. Method of measurement: Blood sample. Cr. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: Blood sample. Uric acid. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: Blood sample. BP. Timepoint: before intervention- 4 week after drug- 4 week after placebo. Method of measurement: Sphygmomanometer. Shiraz University of Medical Sciences Approved 2017-02-28 Research Deputy of Shiraz University of Medical Sciences, Shiraz, Iran. Zand Avenue. Central building Shiraz University of Medical Sciences, Shiraz, Iran. Shiraz Iran (Islamic Republic of)