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

NCT03304938 | Completed DMC

• 1 other identifier: 95010112052
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Pittsburgh Insomnia Rating Scale

  evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale

  4 weeks

Secondary Outcomes (18)

• Fasting Blood Sugar

  4 week

• 2 hours Post Prandial Glucose

  4 week

• Serum Insulin

  4 week

• C Reactive Protein

  4 week

• Uric acid

  4 week

Study Arms (2)

Lavender oil

ACTIVE COMPARATOR

Drug: Lavender Oil

vehicle (Almond oil)

PLACEBO COMPARATOR

Drug: Placebos

Interventions

Lavender Oil DRUG

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

Lavender oil

Placebos DRUG

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

vehicle (Almond oil)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus type 2
• Age between 25-65 years old
• Fasting Blood Sugar between 70-130
• hour post prandial glucose less than 180.
• HbA1C less than 7
• Sleep disorder according to pittsburgh Insomnia Rating Scale more than 5.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (2)

Shahid Motahhari Clinic, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Parasomnias

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mesbah Shams, M.D.

  Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Lavender Essential oil as medication and almond oil as placebo put in similar dark buttle and the head of placebo bottle aromatized whit Lavender Essential oil and all of participants, care provider, investigator and outcomes assessor will be blind.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of internal medicine and endocrinology

Model Details: 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: October 9, 2017
• Study Start: February 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 8, 2019

Record last verified: 2019-04

Locations

IR (2)