Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis

National University of Malaysia (UKM)

Status: Unknown

Conditions: Bacterial Vaginoses

Treatments: Other: Vaginal hygiene wash; Other: placebo wash

Study type: Interventional

Funder types: Other

Identifiers

NCT04846361

FF-2021-031

Details and patient eligibility

About

This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis

Full description

This is a randomized controlled trial comparing the trial hygiene wash against placebo wash as adjunct treatment with oral metronidazole in women with bacterial vaginosis, with microbial analysis of vaginal flora compared to healthy control women

Enrollment: 56 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. premenopausal women who are sexually active 2.willing to use hygiene wash together with prescribed oral antibiotics 3. able to undergo pelvic examination for sampling of vaginal discharge

Exclusion criteria

• 1. Unable to comply with pelvic examination or hygiene wash 2. Concurrent use of hormonal treatment or antibiotic therapy 3. Intrauterine device either copper or levonorgestrel-releasing system 4. Women with known diabetes mellitus 5. Pregnant women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 3 patient groups, including a placebo group

Hygiene wash plus metronidazole

Experimental group

Description:

Hygiene wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week

Treatment:

Other: Vaginal hygiene wash

placebo wash plus metronidazole

Placebo Comparator group

Description:

Placebo wash once daily at night for two weeks plus oral metronidazole 400mg three times daily for 1 week

Treatment:

Other: placebo wash

Healthy control

No Intervention group

Description:

Asymptomatic healthy women with BV negative test