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

Comparison of the effect of Violet plant vaginal gel and metronidazole vaginal gel in treatment of bacterial vaginosis in women of reproductive age

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200129046301N1

Enrollment

Registered

2020-09-14

Start date

2020-04-17

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial vaginosis. Acute vaginitis

Interventions

Intervention 1: Intervention group: Vaginal gel of violet plant oil 5%, 50 mgr, made by Ahwaz School of Pharmacy 5 mg every night applicator vaginally for 7 nights. Intervention 2: Control group: M

Eligibility

Sex/Gender

Female

Age

15 Years to 44 Years

Inclusion criteria

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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Afsharnia

Ahvaz University of Medical Sciences

afsharnia.p @ajums.ac.ir+98 61 3222 2114

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026