Effectiveness of Neem Seed Oil in Treating Lower Reproductive Tract Infections in Women: A Single-Blinded Randomized Controlled Trial in North Karnataka

This research proposal describes a single-blinded, randomized controlled trial comparing the effectiveness of neem seed oil with standard allopathic treatment for lower reproductive tract infections (RTIs) in women at a tertiary care hospital in Hubballi, North Karnataka. The study will involve 100 women, who will be randomly assigned to receive either neem seed oil BC capsules or the standard Clingen Forte vaginal capsule, and followed over a 15-day treatment period. Evaluation will include monitoring symptom resolution, conducting microbiological tests to confirm cure, recording any adverse events, and noting changes to the vaginal microbiome. The research is being led by a multidisciplinary team from both modern and Ayurvedic medical backgrounds, with a focus on rigorous scientific and ethical standards, including participant confidentiality and comprehensive reporting of adverse events.

The study aims to address the significant public health burden of RTIs among Indian women and the limitations of current syndromic management by providing robust clinical data on whether neem seed oil is as effective and safe as existing treatments. The methodology involves strict inclusion and exclusion criteria, single-blind randomization, and structured follow-up visits. All research-related expenses, including medication, diagnostics, and participant compensation, are covered by the KLE Academy of Higher Education and Research Institute. By evaluating both clinical outcomes and safety, the results of this research may help inform the integration of culturally accepted traditional remedies such as neem seed oil into mainstream medical care for women’s reproductive health.