Open-label, Single-arm Clinical Trial to Evaluate Safety, Feasibility and Preliminary Efficacy of proposed Siddha Proprietary UTIC for Management of Uncomplicated Urinary Tract Infection at National Institute of Siddha, Chennai

Urinary tract infection (UTI, GC08.Z) is one of the most common bacterial infections in humansand it disproportionately affects women Worldwide, 150 million patients are diagnosed with UTIs each year. The overall pooled incidence of urinary tract infections was 1.6% They primarily affectthe lower urinary tract, including the bladder and associated structures. Although some cases may resolve spontaneously, many patients seek therapy to relieve symptoms and prevent potential complications. Symptoms include urinary frequency, urgency, dysuria, and suprapubic discomfort.

Currently there are only a few alternatives to antibiotics for treatment of UTI. While antibiotics are the mainstay of therapy, there are growing concerns about collateral effects impacting healthy microbiomes and anti-bacterial resistance patterns. Recent estimates from the CDC indicate that more than 2.8 million antibiotic-resistant infections occur in the U.S. each year, and more than 35,000 people die as a result.

The proposed research fills a key knowledge gap that will be critical in determining the role of a non-antibiotic substance with the potential to treat UTIs by modulating the quorum sensing, biofilm formation, bacterial adherence to surfaces, degrading the biofilm, to restore health and minimize the reliance on antibiotic therapy while also preventing antibiotic resistance andrecurrence infection . In addition, this study will provide early evidence of the short-term symptom and urinary microbiome changes following administration of Siddha based proprietarily formulated poly – herbal chooranam. The ingredients were also chosen based on the antibacterial and biofilm destruction potential to successfully manage the UTI.