The Efficacy and Safety of Herbal Unani Formulations in Chronic Plaque Psoriasis: A Single-arm Clinical Trial.

BACKGROUND

Despite there being advanced treatment options, psoriasis remains an incurable and recurring disease. Noteworthy scholars of Unani (Greco-Arab) medicine have proposed many drugs and formulations for psoriasis but the scientific evidence on the same is scarce. Hence, trial formulations were selected for the study.

PRIMARY STUDY

OBJECTIVES

This study was designed to evaluate the efficacy and safety of two herbal Unani formulations, Ma΄jūn Mundī and Qairūtī Karnab, in the management of chronic plaque psoriasis (CPP).

METHODS/

DESIGN

This open-label, single-arm clinical trial was conducted on 33 participants, of whom 30 completed the 12-week treatment course.

SETTING

This study was conducted at the Central Research Institute of Unani Medicine (CRIUM), Hyderabad, Telangana, India, from 01 August 2018 to 25 May 2019.

PARTICIPANTS

Participants of any gender aged 18 to 65 years with clinically diagnosed CPP and psoriasis area severity index (PASI) ≥ 10% were included in the trial.

INTERVENTIONS: The participants received 5 g of Ma΄jūn Mundī (a semisolid preparation) orally, twice daily with water, followed by the topical application of Qairūtī Karnab (a homogenous paste) to cover the lesions over 12 weeks.

OUTCOME MEASURES: The primary outcome measure was the change in PASI determined pre- and post-trial in terms of mean and percentage reduction. Secondary outcome measures were changes in patient global assessment (PGA) on a 100 mm visual analog scale, investigator global assessment (IGA) on a 6-point scale, and subjective parameters including erythema, induration, scaling, and itchiness.

RESULTS

The analysis revealed a significant reduction in the PASI score, with 12 subjects (40%) achieving PASI 75 and 3 subjects (10%) achieving PASI 90. Significant improvements were also observed in secondary outcome measures with no adverse events.

CONCLUSION

The findings of the study indicate that the trial formulations exhibit a notable anti-psoriatic effect without any adverse effects. The formulations are worthy of further evaluation as an alternative treatment for CPP.