Bacterial vaginosis infection. Vulvovaginal ulceration and inflammation in diseases classified elsewhere
Conditions
Interventions
Intervention 1: One group Metronidazole 250 mg tablet, twice daily 500 mg (every 12 hours) with food for 7 days. Intervention 2: the other group Garsin 500 mg tablet, twice daily 1000 mg (every 12 hou
Treatment - Drugs
One group Metronidazole 250 mg tablet, twice daily 500 mg (every 12 hours) with food for 7 days
the other group Garsin 500 mg tablet, twice daily 1000 mg (every 12 hours) with meal for 7 days.
Sponsors
The International Branch of Shahid Beheshti university of medical sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 44 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarnaz Mohammadzadeh
The International Branch of Shahid Beheshti university of medical sciences
Outcome results
None listed