Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: Candimilt® 500 vaginal capsules: Single STAT dose 500 mg vaginally on day 1 alone
Control Intervention1: Canesten® vaginal tablets: Single STAT dose 500 mg vaginally on day 1 alone.
Sponsors
MILTONIA HEALTH SCIENCE LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with the symptoms of vulvovaginal candidiasis (based on symptoms and signs after speculum examination); 2. Age at least 18 years; 3. Capable of giving written informed consent; 4. Agree to no intercourse for 8 days from the day of beginning of treatment; 5. Agree not to douche or use any intra-vaginal products during the study period (including tampons, medications and devices); 6. Non-pregnant Female patients aged 18 years or more and clinically diagnosed with vulvovaginal candidiasis were included; 7. Capable of giving written informed consent and willing to follow the investigational study procedures and report AEs. 8. Subjects must not be on their menstrual period on the day of screening and do not anticipate their period to begin during treatment (3 days); 9. Subjects must be using an acceptable method of birth control, willing to refrain from sexual intercourse from the date of screening until the follow-up visit (approximately 7 days later); 10. Willing to refrain from the use of any intravaginal/ vulvovaginal products (douches, spermicidal foams or gels, vaginal lubricants, etc) from the screening visit until the follow up visit;
Exclusion criteria
Exclusion criteria: 1. Women will be excluded from the study if they are using or has used any topical or systemic medication, particularly antimicrobial agents over a 30-day period prior to the start of the investigation; 2. Female patient has a positive pregnancy test at screening, is pregnant or lactating, or is planning to become pregnant during the study period; 3. Previously diagnosed with human immunodeficiency virus (HIV) infection, having visible vaginal or cervical mass suspected cancer, and within six weeks of post-abortion or postpartum; 4. Women who are currently or who will require treatment with anticoagulants, lithium, disulfiram, or neuromuscular blocking agents; 5. Women are hypersensitive to clindamycin, clotrimazole or to any excipient in the drug formulation; 6. Female patients who are breastfeeding or intending to breast feed during study period; 7. Study will also exclude patients with history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition; 8. Patients with a history of seizure disorders; 9. Patients with renal impairment (S. Creatinine > 1.5 times the normal reference values) 10. Patients with hepatic impairment. [SGOT, SGPT, S. Bilirubin (Total) >1.5 times the normal reference values; 11. History of uncontrolled Diabetes Mellitus; 12. Patients with uncontrolled hypertension; 13. Inability to comply with the protocol requirements; 14. Participation in any other clinical trial within 3 months of registering in this trial; 15. Patients receiving diuretics or related medicines; 16. Post-menopausal women; 17. Menstruating at the time of diagnosis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis 2.Clinical response 3.Improvement or Resolution of Local signs of inflammation. 4.A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of the studyTimepoint: Baseline, day 7 and day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes from base line to 4 weeks in Quality of life- Questionnaires (Short Form Health-12). 2.Photographic assessments of improvement and tablet dissolution status - will be done for patients who consent for the same. LABORATORY STUDIES 3.Microbiological cure - evaluation: microscopy of vaginal discharge smears will be done on Baseline and on day 7 and 14 (culture method) Timepoint: Baseline, day 7 and day 14 | — |
Countries
India
Contacts
Public ContactDr Gayathri
MGMC&RI
Outcome results
None listed