Health Condition 1: N760- Acute vaginitis
Conditions
Interventions
Intervention1: Group A - BC Capsule: Group A (Test medications) will be administered Ayurvedic medication, specifically ?BC capsules? developed by Nutra Grace in Hyderabad, India (19), which are appro
Sponsors
KLE Academy of Higher Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with lower reproductive tract infections, including vaginitis, cervicitis, and vulvovaginitis (14). 2. Women with the following symptoms: abnormal vaginal discharge, vaginal itching or burning or irritation, painful or uncomfortable intercourse, vaginal odor. 3. Women who are willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Women who are on infertility treatment and are pregnant/ lactating. 2. Patient who are on anti-retroviral therapy (ART) and/or HIV positive, have taken a course of antibiotic within previous 4 weeks. 3. Women who are allergic to the neem products. 4. Patients who have serious medical conditions and currently on medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Cure rate/ Symptom resolution It includes the percentage patients who are symptom-free from abnormal vaginal discharge, itching or burning or irritation, painful or uncomfortable intercourse, vaginal odor at the end of treatment. It will be measured through symptom severity scores 0 to 3 signifying none, mild, moderate, or severe, assessed at baseline on 1st visit and at 2nd visit and after treatment during 3rd visit. Timepoint: 1st Visit 0th Day 2nd Visit 7th Day 3rd Visit 15th Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological Cure Rate The proportion of patients with no detectable pathogen (e.g., Candida albicans, Bacterial vaginosis, T. vaginalis) in the vulvovaginal tract at 3rd visit and it is compared with 1st visit reports.Timepoint: 1st Visit 0th Day 3rd Visit 15th Day;Adverse Event Rate The frequency and severity of adverse effects reported by patients during the study- as irritation, burning, discomfort or any other reasons will be done.Timepoint: 1st Visit 0th Day 2nd Visit 7th Day 3rd Visit 15th Day;Discontinuation Rate The percentage of patients who stop treatment due to adverse effects or other reasons will be noted and calculatedTimepoint: 1st Visit 0th Day 2nd Visit 7th Day 3rd Visit 15th Day;Vaginal Microbiome Changes Any changes in the composition of the vaginal microbiome before and after treatmentTimepoint: 1st Visit 0th Day 2nd Visit 7th Day 3rd Visit 15th Day | — |
Countries
India
Contacts
Public ContactDr Udayashree Voorkara
KLE Jagadguru Gangadhar Mahaswamigalu Moorusavirmath Medical College and Hospitals
Outcome results
None listed