Effectiveness of Subap Plus, a Polyherbal Medicine, on 24-Hour Urinalysis and Early Morning Urine pH in Recurrent Calcium Oxalate Stone Formers: A Pilot Study

Abstract

Introduction Calcium oxalate stone formation is driven by urinary supersaturation, pH, and imbalances in promoters and inhibitors, with acidic nighttime urine (pH <6) promoting crystal nucleation due to low citrate levels. Hence, the purpose of this pilot study was to evaluate the effectiveness of Subap Plus capsule, a polyherbal Ayurvedic formulation, for its preventive effects on early morning pH, 24-hour urinalysis parameters, and supersaturation indices in recurrent calcium oxalate stone formers. Methodology A two-week nonrandomized, uncontrolled pilot study was conducted at Ace Hospital, Pune, India, with 58 patients (20-60 years) with confirmed recurrent calcium oxalate stones. Patients received Subap Plus capsules twice daily alongside dietary advice. Baseline and post-intervention assessments included early morning urinary pH, 24-hour urinalysis (uric acid, oxalate, calcium, citrate, sodium, phosphorus, potassium, and magnesium), and supersaturation indices of calcium oxalate, calcium phosphate, and uric acid. Paired t-tests compared pre- and post-intervention values, and the statistical significance was set to p ≤ 0.05. Results Significant improvements included increased early morning pH (5.55 ± 0.39 to 5.80 ± 0.51, p = 0.001), decreased uric acid (311.38 ± 161.87 mg/day to 275.12 ± 149.82 mg/day, p = 0.017), increased potassium (28.09 ± 14.58 mmol/day to 35.16 ± 16.30 mmol/day, p = 0.002), and decreased uric acid supersaturation (0.53 ± 0.45 to 0.37 ± 0.38, p = 0.006). Citrate showed a trend toward an increase (623.16 ± 429.93 mg/day to 702.99 ± 429.50 mg/day, p = 0.068), and calcium oxalate supersaturation decreased nonsignificantly (2.87 ± 3.27 to 2.37 ± 1.66, p = 0.206). Calcium phosphate supersaturation increased in 37 (63.79%) of patients (p = 0.263). Conclusions The study concluded that the Subap Plus capsule demonstrated effectiveness in modulating early morning pH and urinary parameters to prevent calcium oxalate stone recurrence. The current study supports the role of Ayurvedic polyherbal formulations in urolithiasis management. However, large, randomized controlled trials are essential to confirm efficacy and address limitations, such as the short intervention duration. Hence, future research should optimize the formulation to enhance preventive effects.

Keywords: early morning ph; subap plus capsule; supersaturation index; urinalysis; urolithiasis.