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Comparison of two topical formulations containing clindamycin and clotrimazole in patients with vaginal infections

Phase 4
Completed
Conditions
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
Registration Number
CTRI/2011/04/001698
Lead Sponsor
Bharti Daswani
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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