Efficacy of Unani Combination Therapy in the Management of Acne Vulgaris: A Randomised Standard Controlled Study

Abstract

Acne vulgaris is one of the common chronic inflammatory diseases of the pilosebaceous unit with multiple pathophysiologies affecting adolescents mainly. Aims: To evaluate the efficacy of Shahtra (Fumaria indica) orally along with the topical use of Zimad Muhasain and the management of moderate to severe category of acne vulgaris on the Global Acne Grading System (GAGS) scale. Material & Methods: This was a randomized standard control clinical study. The test group patients were given Shahtra ( 500 mg), 2 capsules twice daily with a local application of Zimad Muhasa paste once daily; the control group patients were given tablet Azithromycin 500 mg thrice weekly with a local application of Benzoyl peroxide 5% gel once daily for 8 weeks. Result: In the test group, there was a 77.3% reduction in the GAGS score at the final follow-up with p<0.0001; in the control group, there was a 69.8% reduction in GAGS score with p<0.0001, showing extremely significant improvement in both groups. The results indicate the superiority of the test group regimen over the control group by at least 7%. Furthermore, adverse effects like burning sensation, dryness, and itching due to Benzoyl peroxide and diarrhoea due to Azithromycin were only reported in the control group whereas the Unani formulations were found to be free of such adverse effects. Conclusion: The test formulations comprising a dried aqueous extract of Shahtra and Zimad Muhasa were found to be more effective and safe in the management of acne vulgaris in moderate to severe acne, compared to the control combination of Azithromycin and Benzoyl peroxide gel.