Efficacy and safety of polyherbal formulation in the management of acne vulgaris: An open label, baseline-controlled, single center, prospective clinical trial

Abstract

Background

Acne vulgaris, a common skin condition, presents a significant challenge in clinical management. This prospective baseline-controlled clinical trial aimed to evaluate the therapeutic efficacy and safety of SAFI syrup, an Indian traditional polyherbal formulation, for the treatment of acne vulgaris.

Materials and methods

Two hundred fifty subjects were initially enrolled and 213 excluded based on inclusion and exclusion criteria. Biochemical analysis was performed at baseline, and 3 subjects were excluded due to abnormal laboratory results. Thirty-four subjects received SAFI syrup treatment and were assessed at various time points over 90 days.

Results

The study found that SAFI syrup treatment was well-tolerated, with no statistically significant differences in safety parameters (serum ALT, AST, creatinine and BUN) between baseline and 90 days (p > 0.05). Neutrophil levels decreased significantly during treatment (p 0.04). In terms of acne grading, most patients exhibited moderate to severe acne at the beginning, but after 90 days of SAFI treatment, the majority of study subjects showed significant improvement (P < 0.001), with several achieved acne grades of 0. Leaky gut analysis revealed a substantial reduction in leaky gut scores (p 0.001), indicating improved gut health in most subjects.

Conclusion

This 90-days interventional study suggests that SAFI syrup, a polyherbal formulation, is an effective and safe option for managing acne vulgaris. The treatment resulted in significant improvements in acne grading scores, leaky gut analysis, and laboratory parameters of efficacy and safety. These findings support the use of SAFI Syrup as a viable treatment for acne vulgaris, providing a potential solution for this challenging skin condition.