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CLINICAL TRIAL article

Front. Med.
Sec. Dermatology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1523441

Differential effects of clary sage (Salvia sclarea L.) oil and linalyl acetate on depression levels in diabetic foot ulcer patients with T2DM: a randomized blinded controlled trial

Provisionally accepted
Ji Won Son Ji Won Son 1Purum Kang Purum Kang 2Sun Seek Min Sun Seek Min 3Geun Hee Seol Geun Hee Seol 1*
  • 1 Korea University, Seoul, Republic of Korea
  • 2 Woosuk University, Jeonju, North Jeolla, Republic of Korea
  • 3 College of Medicine, Eulji University, Daejeon, Daejeon, Republic of Korea

The final, formatted version of the article will be published soon.

    Background: Diabetic foot ulcer (DFU) is a significant global health concern due to its substantial burden on individuals and healthcare systems. In addition to its physical impact, DFU has emotional effects on patients. This study analyzed the effects of inhaling clary sage (CS; Salvia sclarea L.) or linalyl acetate (LA) on depression and psychological factors in patients with DFU.Methods: This study, performed at the Diabetic Wound Center, enrolled DFU patients, categorized as having mild or moderate to severe depression based on visual analog scale (VAS) for depression scores.Patients were randomized to inhalation of 5% CS oil, 5% LA or almond oil (control) by natural breathing. Blood pressure, heart rate, Depression-VAS, Anxiety-VAS, and Stress-VAS were measured before and after inhalation.Results: This study enrolled 72 patients with DFU, including 43 with mild and 29 with moderate to severe depression. Of the 43 patients with mild depression, 14, 14, and 15 were randomized to inhalation of CS, LA, and almond oil, respectively. Of the 29 patients with moderate to severe depression, 9, 11, and 9 were randomized to inhalation of CS, LA, and almond oil, respectively. Compared with inhalation of almond oil, inhalation of CS oil significantly reduced stress (p<0.05) and (p<0.01) in patients with mild depression, whereas inhalation of LA significantly reduced anxiety-VAS (p<0.05) and depression-VAS (p<0.05) in patients with moderate to severe depression.Conclusions: Inhalation of CS oil may have the potential to alleviate stress and anxiety in DFU patients with mild depression, whereas inhalation of LA may have the potential to alleviate anxiety and depression in DFU patients with moderate to severe depression. These findings suggest that adjunct therapy in DFU patients should be individualized according to the degree of depression.Clinical trial registration: http://cris.nih.go.kr/, registration number: KCT0009722.

    Keywords: Clary sage, Linalyl acetate, Diabetic foot ulcer, complementary and alternative medicine, Depression

    Received: 06 Nov 2024; Accepted: 07 Jan 2025.

    Copyright: © 2025 Son, Kang, Min and Seol. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Geun Hee Seol, Korea University, Seoul, Republic of Korea

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