Effectiveness of vaginal tablets of vitamin C with metronidazole on treatment of bacterial vaginosis. (A randomised , double blind , control trial )

Phase 3

Conditions: Bacterial Vaginosis.
Inflammatory diseases of female pelvic organs
N70-N77

Registration Number: IRCT2015042521917N3

Lead Sponsor: Tabriz University of Medical Sciences. Women’s Reproductive Health Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 160

Inclusion Criteria

Inclusion Criteria: non-pregnant and non breastfeeding married women age between 18 -45 Years Old,diagnosis of bacterial vaginosis with contemporary presence of at least three out of four Amsel criteria and gain score 4 to 6 with clue cells or score 7 to 10 without clue cells in Nugent scoring system, have willing to participate to study , possibility to attending center in schedule time for post treatment follow up , husband’s monogamous , Filling the Informed Consent Form;

Exclusion criteria: chronic disease , consumption of vaginal medication or douching during the recent weeks , Immune deficiency syndrome, consumption of antibiotic during the recent weeks , consumption of rifampin –phenytoin- phenobarbital and any anticoagulant agents , other vaginal infections ,presence of unknown vaginal bleeding .

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and laboratory criteria based on Amsel and Nugent scoring system . Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by clinical measurements of diseases and laboratory tests.;Malodon discharge. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.;Itching. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.;Dyspareunia. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.;Having fishy smell during sexual intercourse. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by asking from patient.

Secondary Outcome Measures

Name	Time	Method
The vaginal PH change. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: PH paper scale.;Change in Clue Cells. Timepoint: Before intervention, 10 ± 1 and 30 ± 3 days after treatment. Method of measurement: Measured by laboratory tests.