Formulation and Clinical Evaluation of A Topical Dosage Form of Alkanna orientalis Root Extract for Management of Pressure Lesions: A Pilot Cross-Sectional Clinical Trial

Abstract

Background: Pressure lesions are chronic wounds causing the development of infection and inflammation into deeper structures and finally necrosis. In Persian medicine, Alkanna orientalis (Boraginaceae) has been used for centuries as a naturally derived remedy for managing lesions. A cross-sectional pilot clinical trial was conducted to assess the wound healing effect of an ointment made of chloroform extract of roots of A. orientalis (CERAO). Methods: Sixty patients (36 men and 24 women) diagnosed with bedsore staging 1-2 entered the study for one year. They were divided into two groups of control and treatment with equal proportions. The control group received conventional treatment from the hospital, including irrigation serum, mupirocin, phenytoin ointments, and gauze dressing. After rinsing and cleansing with normal saline, in the intervention group, patients received a thin layer of CERAO once daily for four weeks. Clinical outcomes were measured at weeks 2 and 4. Results: Recovery assessment was carried out by measuring wound area, days of epithelia formation, and complete wound closure. The difference between the two groups was statistically significant (P-value <0.05) in terms of the mentioned criteria. The recovery percentage was 26.7% and 60% for the control and treatment groups, respectively. In the control group, 16.7% of the study population experienced the development of wounds, while in the intervention group, wound progression was not observed. Conclusion: The results of this pilot study indicated that the clinical efficacy of CERAO could be promising and a replacement for conventional treatment of pressure ulcers.