The effect of Ginseng on vaginal pH and vaginal maturation index
- Conditions
- Atrophic vaginitis.Postmenopausal atrophic vaginitis
- Registration Number
- IRCT20120718010324N48
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
Married women with monogamous husband
Having age between 45 to 60 years
Passing minimum 12 months and maximum 10 years from the Last menstrual period
Having sexual intercourse at least two times per month
Natural menopause, not after surgery (hysterectomy)
Coronary artery disease or other heart problems such as significant arrhythmia
Uncontrolled diabetes mellitus,
Uncontrolled hypertension
Blood pressure lower than 90/50 mmHg,
A history of radical hysterectomy
Anatomical deformity of external genitalia
A history of cerebrovascular disease or central nervous system disease
A history of spinal cord injury or related surgery
Liver dysfunction
Kidney dysfunction
Taking of medicines such as Amlodipine, Valerian, and Lorazepam (which are known to have interactions with ginseng)
A history of chemotherapy or pelvic radiation
Having mental disorders such as schizophrenia, mania and ...
Present use of phytoestrogens and other complementary or herbal medicines
Existence of post coital bleeding or spotting
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaginal maturation index. Timepoint: Before and 4 weeks after intervention with drug/placebo. Method of measurement: To determine the vaginal maturation index, the liquid base pap-smear will prepare before and after intervention, and the related index will calculate by the pathologist.;Vaginal pH. Timepoint: Before and 4 weeks after intervention with drug/placebo. Method of measurement: The vaginal pH will be measured with Merck's pH meter strips with a precision of 0.5.;Atrophic vaginitis symptoms. Timepoint: Before and 4 weeks after intervention with drug/placebo. Method of measurement: To determine the atrophic vaginitis symptoms, a 5-items questionnaire including vaginal dryness, itching, burning, abnormal discharge and dyspareunia will be used.
- Secondary Outcome Measures
Name Time Method Pelvic floor muscles strength. Timepoint: Before and 4 weeks after intervention with drug/placebo. Method of measurement: International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-short form) including 4-items. will be used for assessing the pelvic floor muscles strength.