Safety, Efficacy, and Physicochemical Characterization of Tinospora crispa Ointment: A Community-Based Formulation against Pediculus humanus capitis

Abstract: The high prevalence of pediculosis capitis, commonly known as head lice (Pediculus humanus capitis) infesta- tion, has led to the preparation of a community-based pediculicidal ointment, which is made of common household items and the extract of Tinospora crispa stem. The present study aimed to evaluate the safety, efficacy, and physicochemical characteristics of the T. crispa pediculicidal ointment. The physicochemical properties of the ointment were characterized, and safety was determined using acute dermal irritation test (OECD 404), while the efficacy was assessed using an in vi- tro pediculicidal assay. Furthermore, the chemical compounds present in T. crispa were identified using liquid-liquid ex- traction followed by ultra-performance liquid chromatography quadruple time-of-flight mass spectrometric (UPLC-qTOF/ MS) analysis. The community-based ointment formulation was light yellow in color, homogeneous, smooth, with distinct aromatic odor and pH of 6.92±0.09. It has spreadability value of 15.04±0.98 g·cm/sec and has thixotropic behavior. It was also found to be non-irritant, with a primary irritation index value of 0.15. Moreover, it was comparable to the pedicu- licidal activity of the positive control Kwell®, a commercially available 1% permethrin shampoo (P > 0.05), and was signifi- cantly different to the activity of the negative control ointment, a mixture of palm oil and candle wax (P < 0.05). These find- ings suggested that the community-based T. crispa pediculicidal ointment is safe and effective, having acceptable physi- cochemical characteristics. Its activity can be attributed to the presence of compounds moupinamide and physalin I.