A clinical study to evaluate the effect and safety of B C CAPS in Abnormal vaginal discharge due to microbial infections
- Conditions
- Health Condition 1: N898- Other specified noninflammatory disorders of vagina
- Registration Number
- CTRI/2021/04/032728
- Lead Sponsor
- TRA GRACE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Age 18- 45 yrs
2. Subjects with presence of signs and symptoms such as irritation, soreness, dysuria, vulvovaginal inflammation (edema, erythema) and abdominal pain.
3. Subjects with confirmed laboratory diagnosis of abnormal vaginal discharge.
4. Subjects willing to give written informed consent and come for a regular follow up
1. Allergy to neem products.
2. Pregnant subjects.
3. Patients who had taken oral or intravenous antifungal agents within 4weeks or used topical vaginal antifungal drugs within 1 week before enrollment.
4. Terminally ill patients or patients with severe cardiac, hepatic renal or cerebrovascular disease, malignancy, chronic uncon-trolled systemic disease e.g. hypertension, collagen disorders, etc or any other serious medical illness.
5. Patients who have participated in a new drug study in the past 3 months.
6. Any other condition that in the opinion of the investigator does not justify the patientâ??s participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in microbiological parametersTimepoint: Baseline and Day 14
- Secondary Outcome Measures
Name Time Method Change in Clinicianâ??s assessment of symptomsTimepoint: Baseline, Day 7 and Day 14;Change in Subjective assessment of symptomsTimepoint: Baseline and Day 1 to 14;Continuous monitoring for AEs and SAEsTimepoint: Day 1 to 14