Health Condition 1: null- Non-pregnant women above 18 years with clinical diagnosis of vaginitis of infective origin, willing to participate in the study and abide by the study rules
Conditions
Interventions
Intervention1: ClinSup-V3 ER: 3 day treatment with intravaginal ER tablets containing 100mg clindamycin and 200mg clotrimazole
Control Intervention1: ClinSup-V3: 3 day treatment with intravaginal soft
Sponsors
Bharti Daswani
Eligibility
Inclusion criteria
Inclusion criteria: Women with symptoms of vaginal discharge and/or odor and a clinical diagnosis of vaginitis of infective origin [based on symptoms and signs on per speculum examination] Age at least 18 years Capable of giving written informed consent Agree to no intercourse for 8 days from the day of start of treatment Agree not to douche or use any intravaginal products during the study period (including tampons, medications and devices)
Exclusion criteria
Exclusion criteria: Post-menopausal women Menstruating at diagnosis Pregnancy Any antifungal or antibiotic use 14 days prior to enrolment Use of oral or intravaginal antibiotics within the past 2 weeks Immunosuppressive drug within 4 months Presence of vaginal / vulval ulcer Presence of any other vulval, vaginal or medical condition, including cervical neoplasia/ treatment that might confound treatment response Inability to keep return appointments History of hypersensitivity to clotrimazole, clindamycin or lincomycin History of regional enteritis, ulcerative colitis or ?antibiotic associated? colitis Significant disease or acute illness that in the Investigators assessment could complicate the evaluation Intrauterine Device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidial vaginitisTimepoint: 8th day after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients showing absence of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for bacterial, trichomonal or candidial vaginitisTimepoint: 29th day after initiation of treatment;Number of patients that are able to successfully complete the 3 day treatment course without a break or experiencing intolerable side-effectsTimepoint: 8th day after start of treatment | — |
Countries
India
Contacts
Public ContactBharti Daswani
B. J. Medical College, Pune
Outcome results
None listed