Determining the effect of Flaxseed oil vaginal gel compared to vaginal lubricant gel on vaginal dryness in postmenopausal women
Design
In this research, 94 eligible patients with vaginal dryness referring to Persian Medicine Clinic Ahmadieh were chosen purposefully and a code was allocated to each one of them. Then, patients were randomly divided into two control and intervention groups
Settings and conduct
After the explanation of the study for people referring to Persian Medicine Clinic Ahmadieh who have Inclusion criteria, all participants are given consent.The pelvic exam was performed and the Vaginal Health Index (VHI) is determined and lam is provided to determine Vaginal Maturation Index (VMI). Subjective symptoms of vaginal dryness include dyspareunia, vaginal burning, dryness and vaginal itching based on visual analog scale will be recorded.. Patients are randomly assigned to one of the groups and take the drug vaginally with the applicator 3 nights a week for 8 consecutive weeks. They will be visited at weeks 0, 2, 4, and 8, and all tests will be repeated at the end of the study
Participants/Inclusion and exclusion criteria
Inclusion criteria: Postmenopausal women aged 45-65 years, Menopause diagnosis with one of these symptoms: had a history of at least 1 year of amenorrhea or a high level of follicle-stimulating hormone (FSH) above 40 or bilateral oophorectomy؛ Non-Inclusion criteria: history of oral estrogen consumption in the 8 weeks prior to study, active vaginal infection, systemic disease
Intervention groups
Flaxseed oil vaginal gel؛ Vaginal lubricant gel
Main outcome variables
Subjective symptoms of vaginal dryness include burning, dyspareunia, itching and dryness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160402027170N2
Registration date:2017-12-20, 1396/09/29
Registration timing:prospective
Last update:2017-12-20, 1396/09/29
Update count:0
Registration date
2017-12-20, 1396/09/29
Registrant information
Name
Fatemeh Nejatbakhsh
Name of organization / entity
medical University Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6675 4151
Email address
nejatbakhsh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Flaxseed oil vaginal gel with lubricant vaginal gel on the vaginal dryness in postmenopausal women
Public title
The efficacy of Flaxseed oil on the vaginal dryness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal women aged 65-45
Menopause diagnosis with one of these symptoms: had a history of at least 1 year of amenorrhea or a high level of follicle-stimulating hormone (FSH) above 40 or bilateral oophorectomy
Exclusion criteria:
History of oral estrogen consumption in the 8 weeks prior to study
Active vaginal infection
Systemic disease
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation to treatment groups was conducted by an independent researcher using a random number sequence, generated with a computer-generated randomization scheme, according to a randomized block design. The block size was six. The randomization list was concealed from the primary researcher who enrolled and assessed participants in sequentially numbered, sealed, opaque envelopes
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, near Quds St., Keshavarz Ave
City
Tehran
Province
Tehran
Postal code
1417733161
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.TUMS.REC.1394.2057
Health conditions studied
1
Description of health condition studied
Vaginal dryness in postmenopausal women
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
Score of vaginal dryness in Visual Analoge Scale (VAS)
Timepoint
Before the intervention begins, the end of the intervention
Method of measurement
Visual Analoge Scale (VAS)
2
Description
Score of vaginal burning in Visual Analoge Scale (VAS)
Timepoint
Before the intervention begins, the end of the intervention
Method of measurement
Visual Analoge Scale (VAS)
3
Description
Score of vaginal itching in Visual Analoge Scale (VAS)
Timepoint
Before the intervention begins, the end of the intervention
Method of measurement
Visual Analoge Scale (VAS)
4
Description
Score of dyspareunia in Visual Analoge Scale (VAS)
Timepoint
Before the intervention begins, the end of the intervention
Method of measurement
Visual Analoge Scale (VAS)
Secondary outcomes
1
Description
Score of Vaginal Health Index (VHI)
Timepoint
Before the intervention begins, the end of the intervention
Method of measurement
Vaginal Health Index (VHI) questionnaire
2
Description
Percentage of Vaginal Maturation Index (VMI)
Timepoint
Before the intervention begins, the end of the intervention
Method of measurement
Vaginal Maturation Index (VMI) questionnaire
Intervention groups
1
Description
Intervention group: Flaxseed oil vaginal gel with the applicator 3 nights a week for 8 consecutive weeks
Category
Treatment - Drugs
2
Description
Control group: Lubricant vaginal gel with the applicator 3 nights a week for 8 consecutive weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Medicine Clinic Ahmadieh
Full name of responsible person
Nejatbakhsh Fatemeh
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 0837
Email
Nejatbakhsh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sahraeian, Vice Chancellor for research of Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, near Quds St., Keshavarz Ave.
City
Tehran
Province
Tehran
Postal code
1417733161
Phone
+98 21 8899 0837
Email
Rojarahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nejatbakhsh Fatemeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8899 0837
Email
Nejatbakhsh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nejatbakhsh Fatemeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1446663361
Phone
+98 21 8899 0837
Email
Nejatbakhsh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nejatbakhsh Fatemeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No 27, Corner Alley Tabriz, Sarparast Shomali Str, Taleghani Ave
City
Tehran
Province
Tehran
Postal code
1416663161
Phone
+98 21 8899 0837
Email
Nejatbakhsh@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Information about the main outcome after unidentifiable people can be shared
When the data will become available and for how long
Since print results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data can be used by Iranian and non-Iranian researchers in the field of medical sciences in order to perform IPD Meta-analysis and mentioning the name of the corresponding author of the original article in the colleagues of the secondary article. Other analyzes (other statistical models) are not acceptable and researchers are not allowed to use data to write initial studies.
From where data/document is obtainable
Email the corresponding author of the article Nejatbakhsh@tums.ac.ir
What processes are involved for a request to access data/document
The requester sends a letter to the corresponding author of the article and sends a valid certificate of employment in academic and scientific institutions. The author responds within a maximum of 3 weeks and sends the data file