Considering the high prevalence of sleep disturbance in diabetic patients and the effectiveness of lavender oil in sleep disorders in this study, the effect of lavender on sleep disorders and metabolic factors in type 2 diabetes patients will be studied.This study is designed as Cross-over double-blind placebo-controlled randomized clinical trial. 40 patients with diabetic type2 and sleep disorder with the inclusion criteria will enter into the study and randomly assign to first intervention group and first placebo group. The patients inintervention 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 and the placebo group pour 3 drops of placebo oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 week. After 1 week washout the patients will be crossed-over.
Some inclusion criteria are age between 25-65 years old, Fasting Blood Sugar between 70-130, 2 hour post prandial glucose less than 180,
HbA1C less than 7 and Sleep disorder according to Pittsburgh Insomnia Rating Scale more than 5. Some exclusion criteria are any systemic illnesses, Use of sedative or antidepressant drugs, Anosmia, History of allergic reaction to Lavender and headache that start with smell.
Primary outcom will be changed in sleep disorder and also metabolic parameters.
General information
Acronym
Lavender aromatherapy in diabetic patient with sleep disorders
IRCT registration information
IRCT registration number:IRCT201703117297N3
Registration date:2017-10-21, 1396/07/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Mojtaba Heydari
Name of organization / entity
Shiraz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 7679
Email address
mheydari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-08-20, 1396/05/29
Expected recruitment end date
2018-02-18, 1396/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Lavender aromatherapy on sleep quality and metabolic parameters of patients with diabetes mellitus type II and insomnia
Public title
Efficacy and safety of Lavender aromatherapy on sleep quality and metabolic parameters of patients with diabetes mellitus type II and insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:• Age: 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.
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy of Shiraz University of Medical Sciences, Shiraz, Iran.
Street address
Zand Avenue. Central building Shiraz University of Medical Sciences, Shiraz, Iran.
City
Shiraz
Postal code
71345-1978
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.SUMS.REC.1395.191
Health conditions studied
1
Description of health condition studied
diabetes-insomnia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pittsburgh Insomnia Rating Scale
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
pittsburgh Insomnia Rating Scale
Secondary outcomes
1
Description
CRP
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
Blood sample
2
Description
FBS
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
3
Description
TG
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
4
Description
Cholesterol
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
5
Description
LDL
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
6
Description
HDL
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
7
Description
2hPPG
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
8
Description
Serum Insulin
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
9
Description
AST
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
10
Description
ALT
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
blood sample
11
Description
height
Timepoint
before intervention
Method of measurement
meter
12
Description
weight
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
weight scale
13
Description
BMI
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
BMI Index
14
Description
waist circumference
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
meter
15
Description
Hip circumference
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
meter
16
Description
HbA1C
Timepoint
before intervention
Method of measurement
Blood sample
17
Description
Cr
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
Blood sample
18
Description
Uric acid
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
Blood sample
19
Description
BP
Timepoint
before intervention- 4 week after drug- 4 week after placebo
Method of measurement
Sphygmomanometer
Intervention groups
1
Description
Lavender Essential oil
Category
Treatment - Drugs
2
Description
almond oil
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
Full name of responsible person
zeinab nasiri lari
Street address
Shahid Motahhari Clinic, Shiraz University of Medical Sciences
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi
Street address
Zand Av, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mojtaba Heydari
Position
MD,Ph.D Assistant professor in Traditional Persian Medicine
Other areas of specialty/work
Street address
Zand Avenue. Central building Shiraz University of Medical Sciences, Shiraz, Iran.
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 32307594
Email
vcrdep@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mesbah Shams, M.D.Associate professor of Internal medicine and Endocrinology
Position
Associate professor of Internal medicine and Endocrinology, Shiraz University of Medical Sciences