Bacterial vaginosis infection.. Vulvovaginal ulceration and inflammation in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Intervention group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days in combination with Prangos vaginal cream for 7 nights. Intervention 2: Contro
Treatment - Drugs
Intervention group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days in combination with Prangos vaginal cream for 7 nights
Control group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our plasebo vaginal cream.
Sponsors
Deputy of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences.
Eligibility
Sex/Gender
Female
Age
15 Years to 49 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 15-49 year old married women; non pregnant; Not breast feeding; Non menopaused; Non smoker; Willing to participate in the research; Complaine of malodor gray discharge; Not having vaginal infections; Not having unusual vaginal bleeding during the treatment; Not intercoursing during the treatment; Not using vaginal ointment, suppository or douching from two days before during the treatment; Not having chronic diseases like heart or kidney problemes, diabetes, arthoritis,...; Not having any transplant; Not using broad-spectrum antibiotics, hormones, anticoagulant and immunosuppressive medicine; Not having STD disease and not being allergic to metronidazole or topical medications. Exclusion criteria: Unwilling to continue participating in the reseach; Not using vaginal ointment for two consecutive days; Being allergic to metronidazole or Prangos ferulacea vaginal cream or intolerance to any forms of medicine; having intercourse during in the treatment; Having vaginal infections (trichomonas and candidiasis with bacterial vaginosis); become pregnant during treatment; incomplete questionnaire.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Studing the secretion of vaginal regarding to its color, odour and the existence of cluecells with Amsel criteria. Timepoint: Before interference and 7 days after treatment. Method of measurement: Amsel test includes 4 criteria. The existence of at least 3 criteria out of 4 to diagnose bacterial vaginosis is essential. Criteria includes homogen secretion, thin and white looks more like gray, the existence of cluecell in microscope, increasing pH vaginal to more than 4.5 and positive wiff test.;Studing vaginal secretion with Nugent scoring. Timepoint: Before treatment and 7 days after treatment. Method of measurement: Nugent scoring is used to evaluate colored smear. If in vaginal disgharges, undera microscope(whit magnify 100X) the clue cell, gram negative cocobacili or mobilonococs is observed, bacterial vaginosis is diagnosed(Nugent score is more than 4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacterial Vaginosis infection. Timepoint: Before the intervention, seven days after start treatment. Method of measurement: Clinical symptoms questionnaire is completed by patients ( Itching, burning, abnormal discharge, malodor discharge). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsieh Azadpourmotlagh
(International Branch),Shahid Beheshti University of Medical Sciences.
Outcome results
None listed