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

Not Applicable

Completed

• Conditions: Sleep Disturbance; Diabetes Mellitus, Type 2
• Interventions: Drug: Placebos; Drug: Lavender Oil

• Registration Number: NCT03304938
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-09
• Study Start: 2018-02-01
• Primary Completion: 2018-11-01
• Study Completion: 2018-12-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
vehicle (Almond oil)	Placebos	-
Lavender oil	Lavender Oil	-

Primary Outcome Measures

Name	Time	Method
Pittsburgh Insomnia Rating Scale	4 weeks	evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of

Shahid Motahhari Clinic, Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of