Efficacy and safety of Ayush AGT gel-based cream in superficial external wounds: Study protocol of an open-label multicenter interventional single-arm trial

BACKGROUND: Traditional medicine has been extensively used to manage skin wounds since ancient times. Central Council for Research in Ayurvedic Sciences has developed a coded herbal formulation, Ayush AGT gel-based cream, through a systematic drug development process for managing superficial skin wounds. OBJECTIVE: This clinical study is designed to determine the clinical efficacy and safety of Ayush AGT gel-based cream in healing superficial external wounds. MATERIALS AND METHODS: This open-label, multicenter, prospective, interventional single-arm trial is being conducted at three peripheral institutes of the Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India viz. Central Ayurveda Research Institute, New Delhi, and Regional Ayurveda Research Institutes at Ahmedabad and Vijayawada, India. A total of 30 participants will be enrolled in the study from each of the three study sites. Patients of any sex aged 18–60 years with superficial external wounds requiring dressing and solitary wounds not less than 2.5 cm in diameter will be considered for enrollment in the study. The enrolled participants will be managed by the topical application of Ayush AGT gel-based cream on the wound bed once daily, followed by bandaging with the sterile material for four weeks. The outcome measures are time to complete re-epithelialization of the wound, incidence of wound infection, pain during the change of dressing (assessed through visual analog scale), incidence of blistering, and adverse events. DISCUSSION: Ayurveda interventions have been found effective in wound healing in routine clinical practice as well as in published experimental and clinical studies. Ethno-medicine practices also utilize different medicinal plants to manage skin wounds. Several patents on herbal interventions for wound healing have also been granted. However, clinical research to explore the standard wound management for superficial external wounds is not common. So, it is expected that the outcomes of this study will provide a significant lead in the search for safe and effective management options for skin wounds.