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 Itri over line fal Sha over line htra and Marham fina 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 Itri over line fal Sha over line htra (a semisolid paste) and topical Marham fina (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, Itri over line fal Sha over line htra and Marham fina 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.