Ayush AGT gel-based cream in superficial skin wounds: A multicenter, open-label, single-arm exploratory study

Background: Herbal formulations have shown therapeutic potential in wound healing in routine clinical practice as well as in experimental and clinical studies. Ethnomedicine practices also utilize different medicinal plants to manage skin wounds. Aim: The present study was planned to evaluate the therapeutic potential of the topical application of a polyherbal Ayurveda intervention, Ayush AGT gel-based cream, in managing superficial skin wounds. Materials and methods: This multicenter, open-label, prospective, single-arm exploratory clinical study was conducted at Central Ayurveda Research Institute, New Delhi, and Regional Ayurveda Research Institutes at Ahmadabad and Vijayawada, India, on 90 participants. Eligible subjects of any gender aged 18–60 years with superficial skin wounds ≥2.5 cm 2 were enrolled in the study. The study participants were advised to apply Ayush AGT gel-based cream once daily at the time of dressing changing, followed by sterile bandaging for 4 weeks. The primary outcome measure was the incidence of complete wound healing, defined as complete re-epithelialization assessed through the Bates–Jensen tool on every follow-up (on days 7, 14, 21, and 28). Other outcome measures include a change in the score for pain at the time of changing dressing (assessed through Visual Analog Scale), incidence of wound infection, and treatment-emergent adverse events. Results: In this study, 90 participants with superficial skin wounds were enrolled. The incidence of complete wound healing was observed in 78 (86.7%) participants during the treatment period ( P < 0.001). There was a significant reduction (both clinically and statistically) in the score of pain during change of dressing from 6.54 ± 1.96 at baseline to 3.42 ± 1.63 at day 14 ( P < 0.001). A considerable decrease in the overall score of the Bates–Jensen wound assessment tool from 26.60 ± 5.66 at baseline to 14.34 ± 2.91 at day 28 was also observed ( P < 0.001). No treatment-related adverse events occurred during the study. Conclusion: In this multicenter study, Ayush AGT cream exhibited good wound healing activity while being safe and well-tolerated. Further, well-designed RCTs may be planned to generate concrete evidence on the clinical efficacy of this herbal formulation to consider it an effective therapeutic option for wound management.