The comparison of the effect of garsin and metronidazole on bacterial vaginosis
- Conditions
- Bacterial vaginosis infection.Vulvovaginal ulceration and inflammation in diseases classified elsewhere
- Registration Number
- IRCT201207153226N4
- Lead Sponsor
- The International Branch of Shahid Beheshti university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 140
married women; aged 18-44 years old, with single partner whose infection with bacterial vaginosis is diagnosed through clinical Amsel criteria and labratory Nugent criteria ( Patients identified with cervicitis tricamona or candidiadis infections are excluded from the study); they should not use IUD. Also they should not use antibiotics, vaginal drug or immunosuppressive drugs in recent fourteen days. During clinical examination they should not have any breakthrough bleeding or menstrual period. They should not be pregnant, lactating or menopause. They should not have mental retardation or known physical disease; suffering from thyroid disease; coagulation disorders; diabetes and autoimmune diseases. Exclusion criteria: not tolerate any form of drug or discontinuation for at least 48 hours, become pregnant during treatment, forcing the use of antibiotics during treatment.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amsel criteria. Timepoint: Before the intervention, 7-10 days after begining of treatment. Method of measurement: Amsel have 4 criteria: key cells in the wet mount vaginal sample Vaginal dyscharge thin and white uniform - gray, white or yellowish, Vaginal pH equal to or greater than 4/5, positive whiff test. If at least 3 of the 4 cases mentioned above is positive, bacterial vaginosis is brought on .;Nugent criteria. Timepoint: Before the intervention, 7-10 days after beginning treatment. Method of measurement: These criteria are based on the observation lactobacil and other morphotype (Gardnerella vaginalis and Mobiluncus forms) are rated from zero to 10 points, a total score of 7-10 means abnormal vaginal flora (bacterial vaginosis), grades 4-6 (Intermediate) in this study means abnormal vaginal flora. normal flora score is 0-3.
- Secondary Outcome Measures
Name Time Method Bacterial vaginosis infection. Timepoint: Before the intervention, 7-10 days after beginning treatment. Method of measurement: Clinical complaint questionnaires are completed by samples (itching, burning, abnormal discharge, smelly discharge).