Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: Candimilt® 500 vaginal capsules
Single use as STAT dose: Single STAT dose 500 mg (Single use) vaginally on day 1 alone
Control Intervention1: Candid V3® vaginal tablets containing Clot
Sponsors
Miltonia Health Science Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Women with the symptoms of vulvovaginal candidiasis (based on symptoms and signs after speculum examination); 1. Non-pregnant female patients aged 18 years and above and clinically diagnosed with vulvovaginal candidiasis were included; 2. Capable of giving written informed consent and willing to follow the investigational study procedures and report AEs. 3. 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); 4. 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); 5. 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; 6. Patients who have complaint of abnormal vaginal odour with or without complaints of discharge and those were not treated for bacterial vaginosis, intra-vaginal or oral anti-fungal medications or antibiotics, within the last 14 days of enrolment; 7. Patients must abstain from alcohol ingestion during the treatment period and for one day afterward
Exclusion criteria
Exclusion criteria: 1)usage of any topical or systemic medication, particularly antimicrobial agents over a 30-day period prior to the start of the investigation 2)positive pregnancy test at screening 3)Previously diagnosed with (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)breastfeeding 6)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 condition7) Patients with a history of seizure disorders 8)Patients with renal impairment 9) Patients with hepatic impairment10) History of uncontrolled Diabetes Mellitus and hypertension 11)Inability to comply with the protocol requirements 12)Participation in any other clinical trial within 3 months of registering in this trial 13)Patients receiving diuretics or related medicines;14)Post-menopausal women/Menstruating at the time of diagnosis; 15)Use of oral or intravaginal antibiotics within the past 2 weeks; 16)Immunosuppressive drug within 4 months 17)Presence of vaginal / vulval ulcer any other vulval, vaginal or medical condition, including cervicalneoplasia/ treatment that might confound treatment response 18)Inability to keep return appointments19) History of hypersensitivity to clotrimazole, clindamycin or lincomycin or any excipient in the drug formulation regional enteritis, ulcerative colitis or ‘antibiotic associated’ colitis 20) Intrauterine device
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) Number of patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline 4) Improvement or resolution of local signs of inflammation 5) A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of study 6) Changes from baseline to 4- weeks in Quality of Life Questionnaires 7) Photographic assessment of improvement and test product dissolution status 8) Microbiological cure - evaluation : microscopy of vaginal discharge smears will be done on baseline and on day 7 and 14Timepoint: DAy 7, 14 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The secondary endpoint of the study is to assess the safety of subjects enrolled in the intent-to- treat (ITT) population who achieve therapeutic cure by monitoring Adverse drug reactions and laboratory abnormalities if any from baseline to post study on day 28. Timepoint: Baseline and Post study on day 28. | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Mahatma Gandhi Medical College
Outcome results
None listed