Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia (LavenAromDM)
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ClinicalTrials.gov Identifier: NCT03304938 |
Recruitment Status :
Completed
First Posted : October 9, 2017
Last Update Posted : April 8, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 Sleep Disturbance | Drug: Lavender Oil Drug: Placebos | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | 40 diabetic patients with sleep disorder with the inclusion criteria will enter into the crossover study and randomly assign to treatment or placebo groups. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia |
Actual Study Start Date : | February 1, 2018 |
Actual Primary Completion Date : | November 1, 2018 |
Actual Study Completion Date : | December 1, 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Lavender oil |
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 |
Placebo Comparator: vehicle (Almond oil) |
Drug: 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 |
- Pittsburgh Insomnia Rating Scale [ Time Frame: 4 weeks ]evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
- Fasting Blood Sugar [ Time Frame: 4 week ]blood sample
- 2 hours Post Prandial Glucose [ Time Frame: 4 week ]blood sample
- Serum Insulin [ Time Frame: 4 week ]blood sample
- C Reactive Protein [ Time Frame: 4 week ]blood sample
- Uric acid [ Time Frame: 4 week ]blood sample
- Creatinine [ Time Frame: 4 week ]blood sample
- Triglyceride [ Time Frame: 4 week ]blood sample
- Cholesterol [ Time Frame: 4 week ]blood sample
- Low Density Lipoprotein [ Time Frame: 4 week ]blood sample
- High Density Lipoprotein [ Time Frame: 4 week ]blood sample
- Aspartate Aminotransferase [ Time Frame: 4 week ]blood sample
- Alanine Aminotransferase [ Time Frame: 4 week ]blood sample
- weight [ Time Frame: 4 week ]Scale
- Body Mass Index [ Time Frame: 4 week ]Body Mass Index
- waist circumference [ Time Frame: 4 week ]Meter
- hip circumference [ Time Frame: 4 week ]Meter
- Systolic Blood Pressure [ Time Frame: 4 week ]Blood Pressure measurement by digital sphygmometer
- Diastolic Blood Pressure [ Time Frame: 4 week ]Blood Pressure measurement by digital sphygmometer

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Ages Eligible for Study: | 25 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304938
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, Iran, Islamic Republic of |
Study Chair: | Mesbah Shams, M.D. | Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences |
Responsible Party: | Mesbah Shams, MD, Associate professor of internal medicine and endocrinology, Shiraz University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT03304938 |
Other Study ID Numbers: |
95010112052 |
First Posted: | October 9, 2017 Key Record Dates |
Last Update Posted: | April 8, 2019 |
Last Verified: | April 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dyssomnias Parasomnias Diabetes Mellitus, Type 2 Sleep Wake Disorders Nervous System Diseases |
Mental Disorders Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |