Health Condition 1: N898- Other specified noninflammatory disorders of vagina
Conditions
Interventions
Intervention1: B C CAPS
NIMBA BEEJA TAILA VAGINAL CAPSULES: Each liquid filled hard elating contains Proporietory Blend of Neem Seed Oils 500 mg. 2 capsules to be administered manually in vagina befo
Sponsors
NUTRA GRACE
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in microbiological parametersTimepoint: Baseline and Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactMr Sunil Gupta
Pharexcel Consulting
Outcome results
None listed