Protocol summary
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Study aim
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Determine the effect of vaginal cream of red clover on vaginal atrophy in postmenopausal women
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Design
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In this study, 76 postmenopausal women attending the study who referred to Ahvaz Health Center No. 1 were selected and randomly assigned into two intervention and control groups, each assigned a code.
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Settings and conduct
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In this study, which has 3 sucrovers and in the field of healing in health center 1 of east of Ahwaz, researchers, pharmacists and participants are blind and coding of drugs will be done by the supervisor.
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Participants/Inclusion and exclusion criteria
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Participants of 76 randomly selected menopausal women and criteria for entering the study: 1. Age range 45 to 65 years
2. Breast-feeding men for at least one year or having a hormonal test with an FSH level higher than 40 international units and a spouse.
3. Having sexual activity
4. The presence of vaginal atrophy symptoms as well as exclusion criteria include:
1. Vaginal bleeding with unknown cause
2. Vaginal infection
3. Hormonal therapy or consumption of sex hormones 8 weeks before study
4. Use of isoflavones in the diet
5. No desire to continue the study company
6. A suspicious breast mass or breast cancer
7. Hospitalization during research
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Intervention groups
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Vaginal cream 2% red clover is a 8-week-old appliquer prepared from a dry extract of this plant and a placebo that is used in the same way as the intervention group and will be randomly distributed to the participants.
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Main outcome variables
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Vaginal atrophy, vaginal maturation, vaginal acidity, painful intercourse
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171224038036N2
Registration date:
2018-01-11, 1396/10/21
Registration timing:
prospective
Last update:
2018-01-11, 1396/10/21
Update count:
1
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Registration date
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2018-01-11, 1396/10/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-08, 1396/11/19
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Expected recruitment end date
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2018-05-21, 1397/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of red clover vaginal cream on vaginal atrophy in postmenopausal women
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Public title
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Phytoestrogenic treatment of vaginal atrophy in postmenopausal women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age range from 45 to 65 years
Women with at least one year of menstruation or having a hormonal test with an FSH level higher than 40 international units with a spouse
Having sexual activity
The presence of vaginal atrophy
Exclusion criteria:
Vaginal bleeding with unknown cause
Vaginal infection
Hormone therapy or use of sex hormones 8 weeks before study
Taking isoflavones in the diet
History of suspected breast mass or breast cancer
Hospital admission during research
Unwillingness to continue the study company
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Age
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From 45 years old to 65 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
76
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, the clinical trial is 3 blind and the total number of samples is 76, randomization is performed using computer software of random numbers. The subjects are divided into two groups of intervention and control, 38 of which were first to the intervention group and 38 The second number belongs to the control group
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, the drugs are made by the pharmacist and coded and packaged by the supervisor, the researchers, the pharmacist and the participants are blind.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-17, 1396/09/26
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Ethics committee reference number
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IR.AJUMS.REC.1396.728
Health conditions studied
1
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Description of health condition studied
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Vaginal Atrophy
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ICD-10 code
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N95.2
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ICD-10 code description
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Postmenopausal atrophic vaginitis
Primary outcomes
1
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Description
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Vaginal atrophy
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Timepoint
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Before intervention, after intervention
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Method of measurement
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Vaginal smear
Secondary outcomes
1
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Description
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Dyspareunia
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Timepoint
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Before the intervention, two weeks after the intervention, four weeks after the intervention, eight weeks after the intervention
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Method of measurement
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4 degree self-rating scale
2
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Description
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Sexual performance
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Timepoint
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Before and after intervention
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Method of measurement
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Female Sexual Function Index (FSFI)
3
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Description
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Sexual satisfaction
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Timepoint
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Before and after the intervention
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Method of measurement
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Larsson Sexual Satisfaction Questionnaire
4
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Description
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Severity of menopause symptoms
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Timepoint
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Before the intervention, two, four, and eight weeks after the intervention
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Method of measurement
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Menopause Rating Scale Questionnaire
Intervention groups
1
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Description
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Intervention group: Red clover vaginal cream 2% One application once a day for 8 weeks
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo, vaginal cream, once a day for 8 weeks
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available