Diabetes Mellitus, Type 2LavenAromDMNCT03304938
Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
A study testing Lavender Oil in people with Diabetes Mellitus, Type 2 and Sleep Disturbance, run by Shiraz University of Medical Sciences at 2 sites in Iran.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Sleep Disturbance
- What is being tested?
- Lavender Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesIran
- Study dates
- 1 Feb 2018to 1 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- Anosmia
- Headache that start with smell
- Cigarette smocking or substance abuse
- Hospitalization or surgery within 1 months ago.
- Work shift
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Shiraz, Fars
Shiraz University of Medical Sciences
Shiraz, Fars
About this study
Official title: Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Sleep Disturbance
- Being tested
- Lavender Oil, Placebos
- Medical subject headings
- Diabetes Mellitus, Type 2, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender OilDrug
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
PlacebosDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Lavender oil | Active comparator | Not described Receives: Drug: Lavender Oil |
| vehicle (Almond oil) | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Insomnia Rating Scale
evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
Measured: 4 weeks
Secondary outcomes (18)
Fasting Blood Sugar
blood sample
Measured: 4 week
2 hours Post Prandial Glucose
blood sample
Measured: 4 week
Serum Insulin
blood sample
Measured: 4 week
C Reactive Protein
blood sample
Measured: 4 week
Uric acid
blood sample
Measured: 4 week
Creatinine
blood sample
Measured: 4 week
Triglyceride
blood sample
Measured: 4 week
Cholesterol
blood sample
Measured: 4 week
Low Density Lipoprotein
blood sample
Measured: 4 week
High Density Lipoprotein
blood sample
Measured: 4 week
Aspartate Aminotransferase
blood sample
Measured: 4 week
Alanine Aminotransferase
blood sample
Measured: 4 week
weight
Scale
Measured: 4 week
Body Mass Index
Body Mass Index
Measured: 4 week
waist circumference
Meter
Measured: 4 week
hip circumference
Meter
Measured: 4 week
Systolic Blood Pressure
Blood Pressure measurement by digital sphygmometer
Measured: 4 week
Diastolic Blood Pressure
Blood Pressure measurement by digital sphygmometer
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start1 Feb 2018
- Primary completion1 Nov 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesbah Shams, MD, Shiraz University of Medical Sciences
- Investigators
- Mesbah Shams, M.D., Study chair, Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304938
- Sponsor's protocol ID
- 95010112052
- Acronym
- LavenAromDM
- Status last verified
- Apr 2019
- First submitted
- 25 Jul 2017
- Last updated
- 8 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Lavender Aromatherapy on Sleep Quality and Metabolic Parameters of Type 2 Diabetic Patients With Insomnia
- ClinicalTrials.gov ID
- NCT03304938
- Acronym / sponsor ID
- LavenAromDM / 95010112052
- Conditions
- Diabetes Mellitus, Type 2, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lavender oil | Active comparator | Drug: Lavender Oil |
| vehicle (Almond oil) | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- Any systemic illnesses
- Use of sedative or antidepressant drugs
- Pregnancy
- Lactation
- History of allergic reaction to Lavender
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender OilThe 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 | Drug | Lavender oil |
| PlacebosThe 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 | Drug | vehicle (Almond oil) |
Primary outcome
Pittsburgh Insomnia Rating Scale
Time frame: 4 weeks
evaluate the sleep disorder with Pittsburgh Insomnia Rating Scale
18 secondary outcomes
Fasting Blood Sugar
Time frame: 4 week
2 hours Post Prandial Glucose
Time frame: 4 week
Serum Insulin
Time frame: 4 week
C Reactive Protein
Time frame: 4 week
Uric acid
Time frame: 4 week
Creatinine
Time frame: 4 week
Triglyceride
Time frame: 4 week
Cholesterol
Time frame: 4 week
Low Density Lipoprotein
Time frame: 4 week
High Density Lipoprotein
Time frame: 4 week
Aspartate Aminotransferase
Time frame: 4 week
Alanine Aminotransferase
Time frame: 4 week
weight
Time frame: 4 week
Body Mass Index
Time frame: 4 week
waist circumference
Time frame: 4 week
hip circumference
Time frame: 4 week
Systolic Blood Pressure
Time frame: 4 week
Diastolic Blood Pressure
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mesbah Shams, M.D. study chair
Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Oil in people with Diabetes Mellitus, Type 2 and Sleep Disturbance, run by Shiraz University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Insomnia Rating Scale (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2019.