IRCT2016042327534N1 IRCT 2016-10-29 Deputy of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. The effect of Prangos ferulacea vaginal cream on the treatment of bacterial vaginosis. Comparing the therapeutic effect of oral metronidazole alone and oral metronidazole in combination with Prangos ferulacea vaginal cream on bacterial vaginosis cure. 2016-01-21 anticipated 110 Complete https://irct.ir/trial/22534 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 2 Bacterial vaginosis infection.. 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: Control group: metronidazole 250 mg orally, 500 mg twice daily (every 12 hours) with food for 7 days with our plasebo vaginal cream.

public Asieh Azadpourmotlagh

Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.

Tehran Iran (Islamic Republic of) +98 21 8820 2521 azadpurmotlagh@gmail.com; bahramrahimy2015@gmail.com (International Branch),Shahid Beheshti University of Medical Sciences. scientific Asieh Azadpourmotlagh

Faculty of Nursing & Midwifery, In front of Shahid Rajai Hospital, Niayesh Expressway, Valiasr St, District3, Tehran.

tehran Iran (Islamic Republic of) +98 21 8820 2521 azadpurmotlagh@gmail.com; bahramrahimy2015@gmail.com (International Branch) Shahid Beheshti University of Medical Sciences. Iran (Islamic Republic of) 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. 15 years 49 years Female N77 Vulvovaginal ulceration and inflammation in diseases classified elsewhere Treatment - Drugs 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. 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). 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). Deputy of Research, School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. Approved 2016-01-17 Ethics committee of Shahid Beheshti University of Medical Sciences. No. 19, next to the Hemat bridge, Shaheed Abbaspour avenue (Tavanir), Vali Asr street. Tehran Iran (Islamic Republic of)