Clotrimazole treatment in vaginal fungal Infections

Phase 3

Conditions: Health Condition 1: B373- Candidiasis of vulva and vagina

Registration Number: CTRI/2024/05/068227

Lead Sponsor: Miltonia Health Science Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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