Efficacy of Gambhari Phala Granules versus Haridra Khanda in the Management of Sheetapitta (Urticaria): A Randomised Controlled Clinical Trial

Introduction: Large wheals or erythematous, pruritic rashes on the skin are characteristic of urticaria. It is characterised by raised, itchy lesions that may last longer than six weeks in chronic cases and resemble a nettle sting. About 20% of people experience it at some point in their lives. Conventional medicine mainly addresses symptoms and often requires longterm medications, which may cause undesirable side-effects. The hallmark of Sheetapitta (urticaria) is itchy red rashes that may appear nearly everywhere on the body. In Ayurveda, repeated Shodhana (detoxification) and Shaman Chikitsa (internal medication) are recommended for Sheetapitta. Various Acharyas have described different herbal and herbo-mineral treatments for Sheetapitta. Yogratanakara mentions Gambhari phala (Gmelina arborea fruit) with milk. Aim: To determine whether Gambhari phala (Gmelina arborea fruit) granules and Haridra Khanda (Curcuma longa granules) are effective in reducing wheal appearance, intensity and the duration of itching in Sheetapitta. Materials and Methods: This randomised controlled trial was conducted for 30 days at Mahatma Gandhi Ayurved College, Hospital and Research Centre, Wardha, Maharashtra, India. Two equal groups of 60 patients were enrolled. In Group H, Haridra Khanda (Curcuma longa granules) was administered as an adjuvant, while Gambhari Phala (Gmelina arborea fruit) granules were administered to Group G, at a dose of 3 g twice daily for 30 days. The effectiveness of the intervention was evaluated using baseline subjective and objective measures and the data were compared. Results: There was no statistically significant difference between the groups (p-value=0.67), with the mean age of Group G (Gambhari Phala granules) 38.53±13.18 years and Group H (Haridra Khanda) 39.43±12.51 years. Comparable distributions were found for gender, diet, Koshtha and Prakruti (p-value> 0.05 for all). Absolute Eosinophil Count (AEC) values decreased significantly in Group G from 217.20±74.63 to 184.48±50.25 (p-value=0.012); however, Group H did not show a significant change (p-value=0.32). By Day 15 (p-value=0.0056) and day 30 (p-value=0.0001), Group G showed significant improvement from baseline Urticaria Activity Score (UAS) scores, which were similar between groups (p=0.26). According to the 5D Pruritus Scale, 100% of patients in Group G reported less than 6 hours of itching per day by Day 30, compared with 57.1% in Group H. Group G showed a substantial reduction in itching duration across all time points (p-value <0.01). On day 30, 86.2% of patients reported no irritation, compared with 57.1% in Group H (p-value=0.026), indicating a considerable improvement in itching in Group G. During the 30-day treatment period, neither group experienced adverse events. Conclusion: Gambhari Phala granules in patients with Sheetapitta significantly improved clinical outcomes, including reductions in pruritus intensity and wheal severity, without notable adverse effects. Gambhari Phala appears to be a safe and effective Ayurvedic alternative and was more effective than Haridra Khanda in terms of UAS and 5D Pruritus Scale scores. Regarding urticaria symptoms, Haridra Khanda was less effective than Gambhari Phala.