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΄jun Mundi and Qairuti 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΄jun Mundi (a semisolid preparation) orally, twice daily with water, followed by the topical application of Qairuti 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.

Treatment of chronic plaque psoriasis with herbal Unani formulations: A randomized control trial of efficacy and safety.

ETHNOPHARMACOLOGICAL RELEVANCE: Psoriasis, despite modern therapeutic options, is incurable and recurrent. In Unani (Greco-Arab) medicine, many medications and formulations have been prescribed by eminent scholars for conditions clinically similar to psoriasis, though empirical evidence is sparse. Hence, the experimental formulations ItrifalShahtra and MarhamHina were chosen to be compared to the standard therapies PUVAsol and petrolatum for their safety and efficacy. MATERIALS AND METHODS: This open-label, randomized control clinical trial was conducted on 66 male and female participants with chronic plaque psoriasis, ranging in age from 18 to 65 years. In each group, 33 participants were block randomized to either receive Unani formulations or control drugs for 12 weeks. The Unani group received oral Itrifal Shahtra (a semisolid paste) and topical MarhamHina (an ointment) twice daily, and the control group received oral 8-methoxypsoralen and topical petroleum jelly for local application. Participants of both groups were advised to get daily sunlight exposure for 5-15 min. The primary outcome measure was the change in psoriasis area and severity index (PASI) assessed at each visit. Secondary outcome measures were patient global assessment on a 100 mm VAS applied at baseline and after 12 weeks of treatment and change in subjective parameters including erythema, induration, scaling, and itching, assessed on a 5-point scale at every visit. Hemogram, LFTs, RFTs, CXR, ECG, urine, and stool tests were all assessed at baseline and after treatment for the safety of the drugs. RESULTS: The per-protocol analysis was done on 25 participants in each group. The mean ± SD of the psoriasis area severity index (PASI) significantly decreased from 27.88 ± 12.01 and 23.61 ± 9.79 at baseline to 5.01 ± 4.59 and 9.85 ± 7.16 after completion of the trial therapies in both Unani and control groups, respectively. Also, the test formulations outperformed the control drugs on clinically significant endpoints, PASI 50 and PASI 75, with all 25 participants achieving PASI 50 and 76% achieving PASI 75. CONCLUSION: The trial formulations, ItrifalShahtra and MarhamHina may be superior to control drugs PUVAsol and petrolatum in terms of safety, efficacy, and tolerability in the treatment of chronic plaque psoriasis. Thus, the Unani formulations may further be evaluated in a well-designed multicentric superiority trial with an adequate sample size.