The efficacy and safety of herbal combination of Unani Medicine in chronic urticaria: A randomized, controlled study

Background and Aim; Chronic urticaria (CU) is a fluctuating and pruritic erythematous papule that persists for over six weeks. It affects 0.5–1% of the population and interferes with subjective well-being and daily life. Its etiology is highly complex which makes a causal and/or curative treatment difficult. Nonsedating H1-antihistamines are given as symptomatic therapy, which reduces symptoms effectively in <50% of patients. In Unani medicine, urticaria is known as Shara and treated according to its established etiology. The present study objective was to investigate the effect of herbal combination of Unani medicine (HCUM) comprising Rosa damascena Mill, Bambusa arundinacea Linn, Cinnamomum camphora Linn, Mentha arvensis Linn, in comparison with Levocetirizine in CU. Experimental procedure; This randomized open-labeled standard control clinical trial was conducted between 42 male/female patients aged 20–50 years with moderate to severe CU who were randomly allocated in a 3:1 ratio into HCUM and Levocetirizine 5 mg groups. HCUM powder 5.125 Gm and Levocetirizine 5 mg were given for 4 weeks. Urticaria activity score (UAS7) and chronic urticaria quality of life questionnaire (CU-Q2oL) were primary and secondary outcomes and analyzed per protocol. Results: A total of 40 patients completed the study. Data analysis showed a significant decrease (P=<0.001) in the scores of UAS7 (32.43 ± 2.34–14.03 ± 2.16 and 32.10 ± 2.33–28.40 ± 3.78) and CU-Q2oL (67.57 ± 9.56–36.50 ± 3.01 and 65.20 ± 11.78–59.60 ± 11.13) in HCUM and Levocetirizine groups respectively. Conclusion: As an alternative treatment in terms of safety, efficacy, tolerability, and quality of life the HCUM treatment proved to be more effective than Levocetirizine 5 mg in moderate to severe CU.