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Clinical Trials/CTRI/2011/04/001698
CTRI/2011/04/001698
Completed
Phase 4

A Comparative Open Labeled Clinical Study to Evaluate the Efficacy and Tolerability of Two different Intravaginal Formulations Containing a Combination of Clindamycin and Clotrimazole in Patients of Bacterial, Trichomonal, Candidial and Mixed Vaginal Infections

Bharti Daswani0 sites60 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Bharti Daswani
Enrollment
60
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Bharti Daswani

Eligibility 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

  • Post\-menopausal women
  • Menstruating at diagnosis
  • 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

Outcomes

Primary Outcomes

Not specified

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