Comparison of the Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis

Phase 3

• Conditions: Bacterial vaginosis.; Acute vaginitis; N76.0

• Registration Number: IRCT20200129046301N1
• Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

The criteria for entering the study: Married non-pregnant and non-lactating women 15 -44 Years old, diagnosis of bacterial vaginosis based on at least 3 out of 4 Amsel criteria and score 4 to 6 with clue cells or a score of 7 to 10 without the presence of clue cells frome the Nugent scoring system, willingness to participate to study, possibility to attending center in schedule time for post treatment follow up, Filling the Informed Consent Form.

Exclusion Criteria

Vaginal bleeding, Frequently vulvovaginits, Candidiasis, Trichomonas vaginalis, Pregnancy, Mensturation, Breastfeeding, Frequent Use of vaginal douches, Consuming alcohol and coumarin anticoagulants and recent use of anti-parasit drugs, Anti-biotic drugs, Immunosuppressive drugs, Multiple sexual partner, Specific diseases such as liver, kidney diseases and central nervous system diseases, Blood dyscrasis, Diabetes, Weakening of the immune system, Sexually transmitted diseases, History of sensitive to the forme of temperament Rocky and topical, History sensitive to metronidazol tablet.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment of bacterial vaginosis. Timepoint: 1 and 4 weeks after the intervention. Method of measurement: According to Amsel criteria: Examination of (vaginal discharge, color, acidity, presence of clue cells, Whiff test ).;Empty. Timepoint: Empty. Method of measurement: Empty.

Secondary Outcome Measures

Name	Time	Method
Vaginal discharge. Timepoint: Before starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Observation.;Vaginal acidity. Timepoint: Before starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Ph strip.;Whiff test. Timepoint: Before starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Koh 10%.;Clue cells. Timepoint: Before starting the intervention, 1 and 4 weeks after the intervention. Method of measurement: Evaluation of clue cells in the wet lam.