Comparison of fenugreek extract vaginal cream with conjugated estrogen vaginal cream on atrophic vaginitis
Design
In this research, 60 eligible menopausal women who affected by atrophic vaginitis, referring to Tabriz health centers will be chosen and will be randomly divided into two groups of control and intervention. Group allocation will be concealed by assigning a unique code to each participants.
Settings and conduct
Participants in intervention group will revived vaginal cream of fenugreek extract 5% 2 times per week for 12 weeks. Women in the control group will recieved vaginal cream of conjugated estrogen .0625 mg , half of applicator 2 times per week for 12 weeks. The location of study will be in Abbasi health center.
Participants/Inclusion and exclusion criteria
Menopausal women older than 45 years which having inclusion and exclusion criteria.
Intervention groups
They will revived vaginal cream of fenugreek extract 5% 2 times per week for 12 weeks.
Main outcome variables
Vaginal symptoms
Vaginal maturation index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150424021917N7
Registration date:2018-02-10, 1396/11/21
Registration timing:prospective
Last update:2018-02-10, 1396/11/21
Update count:0
Registration date
2018-02-10, 1396/11/21
Registrant information
Name
Sevil Hakimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
hakimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of fenufreek extract vaginal cream with ultra low dose conjugated estrogen vaginal cream on atrophic vaginitis among menopausal women.
Public title
Comparison of fenufreek extract vaginal cream with ultra low dose conjugated estrogen vaginal cream on atrophic vaginitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Menopausal women
Physiologic menopasue
Having sexual avtivity
َAffected by atrophic vaginitis
Exclusion criteria:
Vaginal bleeding
Hormone replacement therapy during last 3 months
History of breast cancer or ant type of estrogen dependent cancer
History of breast cancer in first grade relatives (ex. mother, sister)
Estrogen contraindication including history of vein thrombosis, any type of vascular disease, thrombophlebitis,
Age
From 45 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Sample in each participant is Pap smear.
Randomization (investigator's opinion)
Randomized
Randomization description
In this research randomization will be done using random blocks size 4 and 6. Randomization will be individual randomization. The tool of randomization is random allocation software (RAS). For randome allocation, frenugreek extract vaginal cream and conjugated estrogen cream are put in opaque envelopes. On the envelopes A and B code and numbers are written. Envelops will be given to the participants respectively.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, participants, researcher and data analyzer will be blind. Each type of drugs will be the same according to smell, shape and color. the drugs will be accepted code A or B. This code is clarified only of drug formulation specialist. So the participants, researcher and data analyzer will be blind. After data analyzing formulation specialist will be clarified that each code of A and B belong to which group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Street, Tabriz University of Medical Science
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.TBZMED.REC.932
Health conditions studied
1
Description of health condition studied
Atrophic Vaginitis
ICD-10 code
N95.2
ICD-10 code description
Senile (atrophic) vaginitis
Primary outcomes
1
Description
vaginal symptoms score
Timepoint
Vaginal symptoms score will be measured before and 12 weeks after start id intervention.
Method of measurement
For evaluation of this variable we will use of standard questionnare
2
Description
Vaginal maturation index is the second main outcome.
Timepoint
Vaginal maturation index will be measured before and 12 weeks after start id intervention.
Method of measurement
This index is indicated to proportion of parabasal, intermediate and superficial cellules . We will taken pap smear from participants. Percent of superficial cellules will be multiply in 1, percent of intermediate cellules will be multiply in 0.5 and percent of parabasal cellules will be multiply in 0. After that all of numbers will be summed.
Secondary outcomes
1
Description
Vaginal pH
Timepoint
Before and 12 weeks after intervention
Method of measurement
Vaginal pH will be measured with using of pH meter kits.
2
Description
Satisfaction from treatment
Timepoint
12 weeks after start of intervention
Method of measurement
With using of questionnare
Intervention groups
1
Description
Intervention group: ،They will received vaginal cream of fenugreek extract 5%, 0.5 gram or half of applicator twice per week for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: They will received vaginal cream of conjugated estrogen 0.625mg, 0.5 gram or half of applicator twice per week for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Abbasi Health Center
Full name of responsible person
Sevil Hakimi
Street address
Abbasi Street
City
Tabriz
Province
East Azarbaijan
Postal code
51557
Phone
+98 41 3477 7377
Email
hakimis@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Street address
Golgasht street, Attar steet,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Email
hakimis@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
Sevil Hakimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of nursing and midwifery, Shariati street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41347797777
Email
hakimis@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
َSevil Hakimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of nursing and midwifery, Shariati street,
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 7777
Email
hakimis@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sevil Hakimi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of nursing and midwifery, Shariati street,
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3477 7779
Email
hakimis@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Primary and secondary outcomes, as well as side events will be distributed.
When the data will become available and for how long
Six months after publication of results.
To whom data/document is available
Records will be distributed of academic researchers and " research and development" units of pharmaceutical companies
Under which criteria data/document could be used
" Research and development" unit of each pharmaceutical companies can use of records. All requests will be evaluated after receiving formal e- mail and telephone or face to face negotiation.
From where data/document is obtainable
Response person is: Dr. Sevil Hakimi
Address: Iran, Tabriz, Shariati street, school of nursing and midwifery
What processes are involved for a request to access data/document
After 6 months of results publication a request via email is enough for taking records. ! week after receiving request, records are ready for distribution.