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.

Evaluating the safety and efficacy of a polyherbal Unani formulation in dyslipidaemia-a prospective randomized controlled trial.

ETHNOPHARMACOLOGICAL RELEVANCE: Unani System of Medicine offers treatment for obesity and dyslipidaemia. Jawarish Falafili (JF) is a Unani polyherbal pharmacopoeial preparation. It has been used in the treatment of obesity for a long time. Dyslipidaemia is a recognised modifiable risk factor for hypertension, ischemic heart disease and stroke. Limitations of the current conventional therapy have provided scope for research of a potential drug in this medical condition. It was hypothesised that JF may ameliorate dyslipidaemia in human participants. AIM OF THE STUDY: The main objective of this study was to evaluate the safety and efficacy of the JF. MATERIALS AND METHODS: This was a prospective randomized, active-controlled, open-label and parallel-group study. We randomized 74 participants of dyslipidaemia into treatment (n = 38) and control (n = 36) groups. Of them, 30 participants in each group completed the trial. The participants of any sex aged between 30 and 60 years, with serum total cholesterol (TC) ≥200 mg/dl and/or serum triglycerides (TG) ≥150 mg/dl and/or low-density lipoprotein cholesterol (LDL-C) level ≥130 mg/dl and/or high-density lipoprotein cholesterol (HDL-C) level <40 mg/dl were enrolled in this study. The participants of the treatment group were treated with JF (10 gm/day) once and atorvastatin (20 mg/day) was given to the control group for 90 days once at night daily. RESULTS: We observed a significant reduction (treatment group versus control group) in mean serum TC by 22.89% versus 19.36%, TG by 29.90% versus 23.26% and LDL-C by 29.16% versus 27.92% from baseline (p < 0.05). But the change in mean serum HDL-C levels post-treatment was insignificant in both groups (p > 0.05). On intergroup comparison, the magnitude of the difference of mean TC, TG, LDL-C and HDL-C levels between the groups was not statistically significant (p > 0.00.05). CONCLUSIONS: This study concluded that JF and atorvastatin were equally effective in controlling dyslipidaemia. They were tolerated well by all participants and found safe during the course of treatment.