Health Condition 1: N398- Other specified disorders of urinary system
Conditions
Interventions
Intervention1: Metronidazole 500 mg: Metronidazole 500 mg will be administered orally once daily for a duration of seven days as standard treatment for bacterial vaginosis.
Control Intervention1: Prob
Sponsors
SRM Medical College Hospital And Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female participants aged 18 50 years,premenopausal, with regular menstrual cycles (eumenorrhoea: every 28 10 days). 2. Confirmed diagnosis of bacterial vaginosis,defind by Nugent score at screening 3. Willing and able to provide written informed consent. 4. Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea)shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days) 5. No irregularities identified in gynaecological examination (no pathology of reproductive organs, such as myomas, ovarian cysts)as confirmed by a qualified gynecologist. 6. Susceptibility to recurrent vaginitis and/or urinary tract infections, as well as bacterial vaginitis confirmed at visit I. 7. Able to attend scheduled study visits and comply with all study procedures and protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Recent treatments or exposures including systemic or intravaginal antibiotics, antifungals, or vaginal probiotics within the past 14 30 days 2. Current medical conditions such as co-infection with other vaginal pathogens (e.g., vulvovaginal candidiasis, trichomoniasis, STIs), neoplastic disease, or significant mental illness 3. Vulnerable populations including pregnant or breastfeeding women 4. Contraceptive or hormonal interventions including use of mechanical contraceptives (e.g., diaphragms, most IUDs except Mirena), NuvaRing, or vaginal hormonal preparations (e.g., Vagifem, Ovestin, estrogens)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the efficacy of Normoflora BV compared to Metronidazole in the treatment of bacterial vaginosis (BV), assessed by changes in Nugent score over 12 weeks. 2.To compare the recurrence rate of BV within 12 weeks post-treatment between the two study groups, based on Nugent scoring. 3.To assess the change in vaginal pH over 12 weeks as a surrogate marker of vaginal microbial environment and potential for normal microbiota restoration. Timepoint: 1. Efficacy was assessed by changes in Nugent score from baseline (Day 0) to Week 12 (Month 3). Additional Nugent score assessments were performed at Day 15, Day 30, and Month 2 to evaluate early response and durability of treatment. 2. Recurrence of bacterial vaginosis was evaluated at Week 4,8,12 post-treatment using Nugent scoring, with recurrence defined as a Nugent score 3. Vaginal pH was measured at baseline,Day15, Day30, Month 2 and Month 3 to assess restoration and maintenance of the normal vaginal microbial environment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess improvement in symptoms using the reproductive tract infection (RTI) symptom survey. 2. To monitor and record adverse drug reactions throughout the study.Timepoint: 1. RTI symptom scores were assessed at baseline, Day 15, Day 30, Month 2, and Month 3 to evaluate improvement and sustainability of symptom relief. 2.Adverse drug reactions were monitored continuously from treatment initiation (Day 0) until the final follow-up visit at Month 3, with structured assessments conducted at each study visit. | — |
Countries
India
Contacts
Public ContactVarsha M
SRM Institute of Science and Technology (SRMIST)
Outcome results
None listed