Clinical Validation of Unani Pharmacopoeial Formulations Iṭrīfal Shāhtara and Sharbat-i-‘Unnāb in Cases of Buthūr-i-jild (Skin Eruptions)

Introduction: Buthūr-i-jild (skin eruptions) is an inflammatory condition affecting the external surface of the skin. It primarily results from Khilṭ Radī (abnormal humor) caused by the derangement of Akhlāṭ (humors/body fluids). Lesions can appear on any part of the body but are most commonly observed on the back, face, shoulders, and in areas prone to sweating. Soft tissue areas are particularly susceptible. Materials and Methods: An open-label, single-arm, uncontrolled clinical validation study was conducted at the Outpatient and Inpatient Departments of a Regional Research Institute of Unani Medicine over 2 years. The objective was to evaluate the safety and efficacy of the Unani pharmacopoeial formulations Iṭrīfal Shāhtara and Sharbat-i-‘Unnāb in the management of Buthūr-i-jild . A total of 128 subjects provisionally diagnosed with the condition were enrolled; 100 subjects completed the study. The test drugs were administered according to the protocol for 3 weeks. Results: Therapeutic response was measured by the improvement of signs and symptoms using a Visual Analog Scale. Efficacy findings indicated that 13% of patients attained full relief (90%–100%), 42% had significant relief (60%–89%), 31% had partial relief (30%–59%), and 14% had no relief (<30%). The test preparations led to no negative effects and statistically significant changes ( P < 0.05) in clinical parameters at the end of the treatment period. Conclusion: On a 21-day treatment course, Iṭrīfal Shāhtara and Sharbat-i-‘Unnāb were associated with statistically significant within-subject improvement in symptoms and lesion parameters in patients with Buthūr-i-Jild . Considering the uncontrolled, single-arm nature of the design, these data must be viewed as a supportive clinical data.