Abstract BACKGROUND: Vatarakta, also known as Adhayavata, is attributed to diverse etiological factors, such as imbalanced dietary practices, occupational factors, sedentary lifestyles, and environmental influences. The symptomatology of Vatarakta resembles that of gout in contemporary medicine. While nonsteroidal anti-inflammatory drugs), colchicine, and corticosteroids are used in acute management in conventional treatment, there is a growing recognition of the need for safer and more effective alternatives. Ayurvedic formulations, such as Kaishora Guggulu (KG) and Madhusnuhi Rasayana (MR) are used commonly in clinical practice for similar conditions, and they can be potentially validated for their therapeutic potential in gout. OBJECTIVES: The study was designed to evaluate the therapeutic effect and safety of Ayurvedic formulations: KG and MR in the management of Vatarakta (gout). MATERIALS AND METHODS: The study was conducted as an open-label single-arm prospective trial at the Central Research Institute for Hepatobiliary Disorders, Bhubaneswar, Odisha, India. A total of 68 patients meeting the diagnostic criteria for primary gouty arthritis set by the American College of Rheumatology were screened according to the selection criteria, with 55 ultimately participating in the study. The treatment protocol consisted of administering KG (1000 mg) and MR (10 g) twice daily after meals with lukewarm water for 12 weeks, followed by a 2-week follow-up period, without intervention. Clinical outcomes included evaluating changes in various parameters, including clinical assessment, 36-item Short Form Health Survey (SF-36) health survey score, patient’s global assessment score, physician global assessment score (Visual Analog Scale) score for pain, and serum uric acid levels from baseline to the 84th-day visit of the study. RESULTS: After 84 days of the study, statistically significant changes were found in clinical symptoms, joint pain, and SF-36 health survey parameters, including physical functioning, emotional well-being, social functioning, and general health (P < 0.0001). The mean serum uric acid at the baseline was 7.39 ± 0.55, which reduced to 5.35 ± 1.48 after treatment, which was significant (P < 0.0001). During the trial period, no adverse events were reported. CONCLUSION: Despite variations in demographics, such as gender, socioeconomic status, age groups, Prakriti, and geographic region, Ayurveda treatment exhibited a significant response, accompanied by a notable reduction in serum uric acid levels. The absence of adverse reactions throughout the trial period further supports the safety profile of these formulations. These positive outcomes advocate for the use of KG and MR in gout treatment regimens, offering patients a well-tolerated and beneficial therapeutic option.