Safety of Yellow Surat cream in healthy participants (Clinical trial phase 1)
Abstract
Background: Diabetic foot ulcer is a major risk of lower limb amputation. A herbal medicine called Yellow Surat cream, consisting of 11 medicinal plants: Alpinia galangal, Curcuma zedoaria, Acanthus ebracteatus Wall, Suregada multiflora, Zingiber cassumunar, Smilax corbularia, Smilax glabra, Maclura conchinchinenesis, Teminalia bellirica, Rhinacanthus nasuthus and Hydnophytum formicarum, has been anecdotally used for diabetic foot ulcer treatment in the Southern Province of Thailand. Some extracts of this cream have the antibacterial activity. In vivo data, revealed that 1.25% Yellow Surat cream promoted wound healing property. However, there is a lack of clinical trial data regarding to the safety of Yellow Surat cream. Purpose of this study: To evaluate safety of 1.25% Yellow Surat cream and Yellow Surat extract in healthy participants in terms of local skin reaction and short term systemic effects (Clinical trial phase 1). Methods: Ten healthy participants were enrolled (Male = 5). All participants were evaluated for skin reactions by closed patch test under occlusion for 48 and 72 hours. Liver function, renal function, complete blood counts and urine analysis was tested before and after the closed patch test. Results: Mean age of participants was 28.6±5.54 years old. None of the participants showed any skin reactions. Furthermore, all participants had normal laboratory results. Conclusion: Preliminary study revealed the safety of Yellow Surat cream in terms of local reaction and acute systemic effect. Further study should be conducted to evaluate long term safety and efficacy of this product.References
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