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

Shiraz University of Medical Sciences

Status: Completed

Conditions: Sleep Disturbance; Diabetes Mellitus, Type 2

Treatments: Drug: Lavender Oil; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03304938

95010112052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Lavender oil

Active Comparator group

Treatment:

Drug: Lavender Oil

vehicle (Almond oil)

Placebo Comparator group

Treatment:

Drug: Placebos