AN INTERVENTIONAL STUDY TO COMPARE THE EFFECTIVENESS BETWEEN OCIMUM CANUM 3X AND INDIVIDUALIZED HOMOEOPATHIC MEDICINE ON THE PATIENTS HAVING UROLITHIASIS BASED ON THE ASSESSMENT OF USS SCORE: AN OPEN-LABEL RANDOMIZED CONTROLLED TRIAL

Urolithiasis is a common and painful condition characterized by the formation of calculi in the urinary tract, including the kidneys, ureters, and bladder. It affects nearly 12% of the global population during their lifetime and is associated with significant morbidity and recurrence. In India, the burden of renal calculi is high, and many patients experience recurrent episodes leading to complications such as renal impairment if not properly managed. Common risk factors include low fluid intake, high dietary salt, high animal protein consumption, and diets rich in oxalates. Clinically, patients frequently present with flank pain, haematuria, dysuria, nausea, and vomiting. Ultrasonography is widely used for the diagnosis and monitoring of urinary calculi as it is non-invasive and easily repeatable.

Homoeopathy has been widely used in the management of urolithiasis, both through individualized constitutional treatment and organ-specific remedies. Individualized Homoeopathic Medicine (IHM) is prescribed based on the totality of symptoms and patient constitution, while Ocimum canum 3X is considered a clinically important remedy for renal colic and urinary calculi, especially right-sided cases with red or sandy urinary sediment. Although both approaches are commonly used in clinical practice, high-quality comparative research evaluating their effectiveness is limited.

The present study is designed as an open-label randomized controlled trial to compare the effectiveness of Individualized Homoeopathic Medicine and Ocimum canum 3X in patients with urolithiasis. A total of 44 patients diagnosed with renal calculi (3–10 mm) through ultrasonography will be recruited from the outpatient department of the National Institute of Homoeopathy, Delhi, and randomly allocated into two groups. Group A will receive individualized homoeopathic medicines based on homoeopathic principles, while Group B will receive Ocimum canum 3X (4 globules twice daily) for a period of three months.

The primary outcome will be assessed using the Urolithiasis Symptom Score (USS), which evaluates the severity of symptoms such as pain/colic, haematuria, dysuria, number of stones, size of stones, and location of stones. Assessments will be conducted at baseline and after three months of intervention. Secondary outcomes will include the MONARCH scale to assess causal attribution of homoeopathic intervention and the ADR probability scale to monitor any adverse drug reactions during the study period.

The findings of this study are expected to provide scientific evidence regarding the comparative effectiveness of individualized homoeopathic treatment and the organ-specific remedy Ocimum canum 3X in the management of urolithiasis, thereby helping clinicians select appropriate homoeopathic treatment strategies for patients with urinary calculi.