Clinical Effects of the Unani Medicine Formulations Majoon and Tila Baras-e-Aswad on Plaque Psoriasis: A Single-Arm Clinical Study.

BACKGROUND

Psoriasis is a chronic, autoimmune, T-cell-mediated inflammatory disease with an "onset-remission-recurrence" pattern, and is managed symptomatically, therefore the need for treatment is usually lifelong.

PRIMARY STUDY

OBJECTIVE

This study aimed to evaluate the efficacy of Majoon and Tila Baras-e-Aswad, two combination formulations, consisting of herbal, mineral, and animal drugs (antioxidants, anti-psoriatic, antihistaminic, antipruritic, and skin protection with healing activities), prescribed for the treatment of Baras-e-Aswad, having a plaque psoriasis-like diagnosis in Unani medicine.

METHODS/

DESIGN

Open-label single-arm and single-center clinical study with pre-and post-treatment analysis.

SETTING

Conducted in National Institute of Unani Medicine (NIUM) Hospital, Bangalore, India.

PARTICIPANTS

A total of 36 patients with plaque psoriasis with mild to moderate severity and aged 18-60 were included.

INTERVENTIONS: The intervention formulation Majoon 10 g orally and Tila Baras-e-Aswad topically was given for 45 days. Primary Outcome Measures: Evaluation of prognosis with averaged PASI (Psoriasis Area and Severity Index) (EPAP) and dermatology life quality index (DLQI) were the outcome of the study and analyzed per protocol.

RESULTS

The data analysis of 30 patients who completed the study showed a statistically significant result in the EPAP scores (P < .05), which reduced from 1112.57 ± 988.45 at baseline to 1108.95 ± 988.87, 1107.71 ± 988.52, and 1105.57 ± 988.76 on 15th, 30th, and 45th day respectively. DLQI score reduced significantly (P < .05) from 18.60 ± 2.72 at baseline to 15.20 ± 2.90, 10.76 ± 2.07, and 8.00 ± 2.43 on 15th, 30th, and 45th day respectively. The test drugs were found to be tolerable without any adverse effects.

CONCLUSION

This study highlights the positive effect of Majoon and Tila Baras-e-Aswad combination formulation on the clinical efficacy, quality of life, and short-term prognosis in chronic plaque psoriasis patients, providing valuable insights for further research in a well-designed study.