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

Diabetes Mellitus, Type 2 Clinical Trial

— LavenAromDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304938
• Other study ID #: 95010112052
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: April 2019
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Drug:
• Lavender Oil
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
• Placebos
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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Motahhari Clinic, Shiraz University of Medical Sciences	Shiraz	Fars
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Insomnia Rating Scale	evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale	4 weeks
Secondary	Fasting Blood Sugar	blood sample	4 week
Secondary	2 hours Post Prandial Glucose	blood sample	4 week
Secondary	Serum Insulin	blood sample	4 week
Secondary	C Reactive Protein	blood sample	4 week
Secondary	Uric acid	blood sample	4 week
Secondary	Creatinine	blood sample	4 week
Secondary	Triglyceride	blood sample	4 week
Secondary	Cholesterol	blood sample	4 week
Secondary	Low Density Lipoprotein	blood sample	4 week
Secondary	High Density Lipoprotein	blood sample	4 week
Secondary	Aspartate Aminotransferase	blood sample	4 week
Secondary	Alanine Aminotransferase	blood sample	4 week
Secondary	weight	Scale	4 week
Secondary	Body Mass Index	Body Mass Index	4 week
Secondary	waist circumference	Meter	4 week
Secondary	hip circumference	Meter	4 week
Secondary	Systolic Blood Pressure	Blood Pressure measurement by digital sphygmometer	4 week
Secondary	Diastolic Blood Pressure	Blood Pressure measurement by digital sphygmometer	4 week