Bacterial Vaginoses
Conditions
Keywords
vaginal hygiene wash, bacterial vaginosis, microbial analysis
Brief summary
This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis
Detailed 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
Interventions
OTHERVaginal hygiene wash
vaginal hygiene wash containing Propylene Glycol, Ethylhexylglycerin, Lactic Acid, Sodium Pyrrolidone Carboxylic Acid, Alpha-Glucan Oligosaccharide, Lactococcus Ferment Lysate, Octenidine Hydrochloride plus all other ingredients in placebo wash
OTHERplacebo wash
placebo wash containing water, disodium cocoamphodiacetate, sodium chloride, sodium glycolate, acrylates copolymer, potassium laureate phosphate, tripotassium phosphate, laurel glucoside, lauramidopropyl hydroxysultaine, disulfonate de sodium, Polyethylene glycol (PEG)-120 Methyl Glucose Trioleate, Propanediol, Glycol distearate, Laureth-4, Cocamidopropyl betaine, Potassium Lactate, Caprylyl Glycol, Disodium ethylenediaminetetraacetic acid (EDTA), Potassium Hydroxide, and Perfume
Sponsors
Universiti Kebangsaan Malaysia Medical Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
the trial hygiene wash and placebo wash are labelled A or B in identical packaging by manufacturer's company and blinded from both participants and investigators and only revealed at the end of data completion
Intervention model description
hygiene wash plus antibiotic, placebo wash plus antibiotic
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytokines concentration after treatment | 2 weeks after treatment | Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/ml after completed treatment |
| Microbial profile of vaginal flora after treatment | 2 weeks after treatment | DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis |
| Cytokines concentration before treatment | before treatment | Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/mL at baseline |
| Bacterial vaginosis cure rate | 2 weeks after treatment | Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment |
| Visual analog scale of symptoms before treatment | before treatment | self-evaluation of symptom using Visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem |
| Visual analog scale of symptoms after treatment | 2 weeks after treatment | self-evaluation of symptom using Visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem |
| Microbial profile of vaginal flora before treatment | Before treatment | DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbial analysis of vaginal flora 1 month after completed treatment | 1 month after completed treatment | DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis |
| Recurrence of symptoms 1 month after completed treatment | 1 month after completed treatment | Self-rated symptoms using visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem |
Contacts
Primary ContactNurliyana Abdul Razak
Backup ContactIzyan Atiqah Zakaria, B.Med
Outcome results
None listed