The effect of oral lavender essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women: A triple-blind, randomized, controlled trial
The effect of oral lavender essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women:
Design
The controlled clinical trial, with two parallel arms, triple-blind, randomized, phase 3 on 72 patients. Random Allocation Software will be used for randomization
Settings and conduct
The eligible postmenopausal women referring to the Tabriz health centers will be selected through convenience sampling. Participants will be randomly assigned to two groups of consumers of gelatin capsules containing lavender and placebo using a random blocking method with a 1: 1 allocation ratio. The researcher, participant, data analyst, and outcome assessor will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women who spent less than 6 years old after menopause and get a score of 15 to 42 from the Green assessment. Exclusion criteria: Lavender consumption during the last 3 months, hormone therapy during the last 6 months, presence of a serious illness
Intervention groups
The first group will receive one 80 mg gelatin capsule per day containing lavender essential oil for 60 days. The second group will receive one 80 mg placebo capsule per day similar to the first group. The placebo will be taken with the same prescription as the lavender capsule.
Main outcome variables
Changes in mean of Green scale score, serum lipid profile levels, and serum cortisol levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131009014957N13
Registration date:2022-04-27, 1401/02/07
Registration timing:prospective
Last update:2022-04-27, 1401/02/07
Update count:0
Registration date
2022-04-27, 1401/02/07
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral lavender essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women: A triple-blind, randomized, controlled trial
Public title
The effect of oral lavender essential oil on menopausal symptoms, serum lipid profile, and cortisol concentration in postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Be literate enough to fill out a questionnaire or presence of a literate person in the family
Having a normal menopause
Women who were menopause less than 6 years ago
Having a minimum of 45 and a maximum of 60 years of age
Earning a minimum score of 15 and a maximum of 42 in the Green assessment
Exclusion criteria:
Use of tobacco and alcoholic beverages and herbal medicines
Existence of stressors such as the death of first-degree relatives in the last 6 months and job loss
Existence of malignant disease
Recent history of surgery and trauma
Lavender consumption during the 3 months before the study
Use of hormone therapy during the past 6 months
Having known physical and mental illnesses according to self-expression (depression, uncontrolled diabetes, cardiovascular diseases)
Age
From 45 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women will be assigned into two groups of Lavender gelatin capsule or placebo using a randomized blocking method with the 4 and 6-sized blocks and a 1: 1 allocation ratio. The allocation sequence will be generated by the researcher through RAS (Random Allocation Software). The medicines and placebo will be placed in a container. Containers will be assigned numbers from 1 to 72. They will be the same shape, closed, opaque, and contain 60 capsules, and their preparation will be done based on the sequence allocation by the person not involved in the research.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The first group will receive one Lavender essential oil 80 mg capsule daily, and the second group will receive a placebo capsule that will be the same shape, color, and weight. participants, the principal investigator, health care personnel, those evaluating the outcome, the Data Safety and Monitoring Committee, and those drafting the article will be blinded
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Floor 3, No 2 Central Building, Tabriz University of Medical Sciences, Golghasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2022-02-15, 1400/11/26
Ethics committee reference number
IR.TBZMED.REC.1400.1186
Health conditions studied
1
Description of health condition studied
Menopausal symptoms
ICD-10 code
N95
ICD-10 code description
Menopausal and other perimenopausal disorders
Primary outcomes
1
Description
Green scale symptoms score in postmenopausal women
Timepoint
Before and after intervention
Method of measurement
Green questionnaire
2
Description
Serum cortisol levels
Timepoint
Before and after intervention
Method of measurement
Enzyme-linked immunosorbent assay (ELISA) method by ELISA kits
Secondary outcomes
1
Description
Reported possible side effects
Timepoint
After the intervention
Method of measurement
Checklist of possible side effects
2
Description
The level of satisfaction with the intervention received
Timepoint
After the intervention
Method of measurement
Satisfaction checklist received from the intervention
3
Description
Serum levels of lipid profile
Timepoint
Before and after intervention
Method of measurement
By spectrophotometric method with device with Alcyon 300 model and Pars test kit
Intervention groups
1
Description
Intervention group: Recipient of gelatin capsules containing 80 mg of lavender essential oil. The course of drug consumption is 60 days and one capsule is consumed daily after a meal, which is prepared in 30-number packages by Barij Essential Oil Company and will be delivered to the participants in two periods.
Category
Treatment - Drugs
2
Description
Control group: Recipient of placebo in the form of a gelatin capsule that is very similar in color and weight to a lavender gelatin capsule and will be made by Barij Essential Oil Company, except that it will have no effective substance. The placebo will be given to participants with the same instructions as Lavender Gelatin Capsules.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Public health departments in Tabriz
Full name of responsible person
Dr Mitra Yeghaneh
Street address
Nesfrah Squre., Tabriz health center
City
Tabriz
Province
East Azarbaijan
Postal code
5157665633
Phone
+98 41 3444 0057
Email
yeghanehm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
No. 2 Central building of the university, Golgasht street, Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht Street, Imam Reza Hospital, Ground Floor, Research Center of Physical Medicine and Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 1928
Email
farshbafa@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Physical Medicine and Rehabilitation Research Center Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3337 1134
Email
farshbafa@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-khalili
Position
Assistant Profeassor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3337 1134
Email
farshbafa@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main outcome will be published
When the data will become available and for how long
Six months after printing the results
To whom data/document is available
Researchers at institutions have access to data
Under which criteria data/document could be used
In order to help scientific progress in the field of research
From where data/document is obtainable
farshbafa@tbzmed.ac.ir
Dr. Azizeh Farshbaf Khalili
What processes are involved for a request to access data/document
Scientific approval of the applicant by Tabriz University of Medical Sciences