Comparison of the Effectiveness of Vaginal Cream contain extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed; on Vaginal atrophy in postmenopausal Women referred to selected health care centers undercover of Ahvaz Jundishapour medical university in 1398
Determination of the Effectiveness of Vaginal Cream contain extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed; on the Treatment of Vaginal atrophy in postmenopausal Women
Design
In this study, 80 postmenopausal women with vaginal atrophy and inclusion criteria were randomly divided into intervention and control groups.
Settings and conduct
Sample size is 80 and the duration of the intervention is 8 weeks. First, patients are examined for vaginal atrophy and the checklist for symptoms of vaginal atrophy is completed by the researcher. Vaginal discharge is taken to examine vaginal mucosal maturation index, and vaginal pH by a pH meter. Individuals are randomly assigned to one of two groups. An intervention group (Vaginal Cream content extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed) and a control group (placebo vaginal gel) receive an application for 8 weeks. At the end of weeks 2, 4 and 8, patients are evaluated again in terms of clinical signs of vaginal atrophy and vaginal atrophy syndrome. At the end of the study, vaginal pH and vaginal discharge samples are re-examined.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age between 45 to 65; Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit; Presenting symptom of vaginal atrophy; Have sexual activity and single partner. Exclusion criteria; Vaginal infection؛ Genital Abnormalities؛ The use of sex hormones within the 8 weeks preceding study; user of smoke and alcohol and etc; Genital bleeding or spotting of unknown cause; Use of phytoestrogens within the last one month.
Intervention groups
The intervention group (Vaginal Cream content extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed) and control group (placebo vaginal cream)
Main outcome variables
Treatment of vaginal atrophy; Reducing the complications of vaginal atrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190616043909N1
Registration date:2020-04-05, 1399/01/17
Registration timing:retrospective
Last update:2020-04-05, 1399/01/17
Update count:0
Registration date
2020-04-05, 1399/01/17
Registrant information
Name
Golshan tahmasebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4362 8502
Email address
golshanthm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Vaginal Cream contain extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed; on Vaginal atrophy in postmenopausal Women referred to selected health care centers undercover of Ahvaz Jundishapour medical university in 1398
Public title
Comparison of the Effectiveness of Vaginal Cream contain extract of Foenicolum vulgar; Salvia officinalis. L; Flaxseed; on Vaginal atrophy in postmenopausal Women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45 to 65; Amenorrhea at less 12 month or have hormone test with FSH level more than 40 unit; Presenting symptom of vaginal atrophy; Have Sexual activity and single partner;
Exclusion criteria:
Genital abnormalities; breast diseases with unknown reason; liver cholestatic disorders; renal failure; vaginal infection needing treatment; genital bleeding or spotting with unknown reason; hormone therapy or using sex hormones within the 2 months before the study; using of phytoestrogens such as soy, red clover, fenugreek, and vitex within the last one month; body mass index more than 30 .
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method and description:
randomization unit: Individual
Concealment method: opaque and closed envelopes
Create random sequence: generate random numbers by Excel software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study; the participant; researcher and evaluator of the outcome are kept blind by coding the drug and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshty Universit of Medical Sciences
Street address
Valiasr Street, intersection of Niayesh
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-02-25, 1397/12/06
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.261
Health conditions studied
1
Description of health condition studied
Vaginal Atrophy in Postmenopausal Women
ICD-10 code
N95.2
ICD-10 code description
Postmenopausal atrophic vaginitis
Primary outcomes
1
Description
Symptom of vaginal atrophy
Timepoint
At the beginning of the study, 4 weeks and 8 weeks after intervention
Method of measurement
The most bothersome symptom cheklist
2
Description
Clinical signs of vaginal atrophy
Timepoint
At the beginning of the study, 2 weeks, 4 weeks and 8 weeks after intervention
Method of measurement
Check list of clinical signs of vaginal atrophy
3
Description
Vaginal maturation index
Timepoint
Before intervention and after intervention
Method of measurement
Vaginal Smear
4
Description
Vaginal acidity
Timepoint
Before intervention and after intervention
Method of measurement
PH meter
Secondary outcomes
1
Description
Sexual function
Timepoint
Before and after intervention
Method of measurement
Female Sexual Function Index (FSFI) questionnaire
Intervention groups
1
Description
Intervention group:Foeniculum Vulgare, Salvia Officinalis and Flax Seed extracts vaginal cream, every night, an aplicator for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Vaginal gel Placebo, every night, an aplicator for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1
Full name of responsible person
Golshan Tahmasebi
Street address
Shaheed Gandami Street, opposite side of Hoda intermedieat School, between Rastegari and Vakili
City
Ahwaz
Province
Khouzestan
Postal code
6173663369
Phone
+98 61 3377 4366
Email
golshan.tahmasebi70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golshan Tahmasebi
Street address
Shahid Chamran Highway, Yemeni Avenue, next to Taleghani Hospital
City
Ahwaz
Province
Khouzestan
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golshan Tahmasebi
Position
Masters of Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan, Farvardin Street, Vahid Alley, Noran Complex 5
City
Ahwaz
Province
Khouzestan
Postal code
6391715991
Phone
+98 61 4362 8502
Email
golshanthm@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sharareh Jannessari
Position
teacher
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Vali Asr Ave., Intersection of Niayesh, Shahid Beheshti Faculty of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
11858118581
Phone
+98 21 8820 2512
Email
shararehjannesari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Golshan Tahmasebi
Position
Masters of Midwifery student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Golestan, Farvardin Street, Vahid Alley, Noran Complex 5
City
Ahwaz
Province
Khouzestan
Postal code
6391715991
Phone
+98 61 4362 8502
Email
golshanthm@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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