Multidimensional analysis and clinical efficacy: evaluating the therapeutic and metabolic potential of Itrifal Ustukhudus in chronic rhinosinusitis management with four-month surveillance
摘要
Chronic rhinosinusitis (CRS) is a common inflammatory disorder associated with persistent sinonasal symptoms and impaired quality of life. Despite available conventional therapies, many patients experience incomplete relief or adverse effects, highlighting the need for safe and sustainable alternative approaches.
ObjectiveTo evaluate Clinical and Radiological Outcomes of Itrifal Ustukhudus (Itrifal Ustukhudus, a classical Unani polyherbal formulation containing Lavandula stoechas along with Triphala components (Terminalia chebula, Terminalia bellerica, and Phyllanthus emblica)) in Chronic Rhinosinusitis in a prospective real-world surveillance.
MethodsThis prospective, open-label, single-arm surveillance study included 100 adults with chronic rhinosinusitis (CRS) (37 males, 63 females). Participants received Itrifal Ustukhudus for six weeks and were assessed at 15-day intervals during the treatment period. Clinical outcomes were evaluated using the Sino-Nasal Outcome Test-22 (SNOT-22), while radiological changes were assessed using standardized imaging criteria. Safety evaluation included haematological parameters, liver and kidney function tests, erythrocyte sedimentation rate (ESR), and serum uric acid levels. Longitudinal changes were analysed using linear mixed-effects models for repeated measures, with statistical significance set at p < 0.05.
ResultsParticipants demonstrated substantial reductions in SNOT-22 scores from baseline to the end of treatment, indicating marked improvement in sinonasal symptom burden. Radiological improvement was observed in more than half of the participants, with the most notable changes seen in individuals with bilateral sinus involvement. Laboratory parameters, including haematological indices and liver and kidney function markers, remained stable throughout the study period, suggesting an acceptable safety profile. Reductions in ESR and serum uric acid levels were also observed, indicating a potential reduction in systemic inflammatory activity.
ConclusionItrifal Ustukhudus was associated with clinically meaningful improvements in symptoms and favourable radiological trends, with a reassuring safety profile during the study period. However, given the open-label, single-arm design, these findings should be interpreted as preliminary and hypothesis-generating.
CTRI noCTRI/2018/10/016178.