Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy
Condition: Leeches
Study type: Interventional

Summary: 
      Hirudotherapy (HT); It is a traditional treatment method applied using medicinal leeches such
      as Hirudo Medicinalis and Hirudo Verbana.

      Purpose of the study titled "Investigation of oxidant-antioxidant status in patients treated
      with hirudotherapy": To investigate the effect of HT on oxidative stress in healthy
      individuals.
    

Detailed description: 
      Ethics committee decision dated 14.08.2020 and numbered 22-40 was taken from Alanya Alkü
      Medical Faculty Clinical Research Ethics Committee. Participants will be accepted into the
      study after signing and approving the informed consent form (ICF). All procedures performed
      in studies involving human participantswere in accordance with the ethical standards of the
      institutional and/or national research committee and with the 1964 Helsinki declaration and
      its later amendments or comparable ethical standards.

      This study will be carried out at Alanya Training and Research Hospital Traditional and
      Complementary Medicine (Getat) Application Center between 29 March-29 September 2021 with
      fifty (50) volunteers. All participants will receive hirudotherapy twice, 1 month apart.
      Venous blood samples will be taken before the first application (pre-HT) and after the second
      application (post-HT), total antioxidant capacity (TAS) and total oxidant capacity (TOS) in
      the serum portion of the blood samples taken, as well as oxidative stress index
      (OSI=TOS/TAS), ischemia modified albumin (IMA), paraoxonase 1 (PON1), disulfide, natural
      thiol, total thiol, arylesterase (ARES) will be measured. The above biochemical parameters
      will be investigated in serum using fully automatic colorimetric methods.

      Statistical analyzes of the data were performed using the SPSS 15.0 program (SPSS Inc. and
      Lead Tech. Inc. Chicago. USA). The significance of the difference between the two groups was
      evaluated with the Independent samples t test, which is a parametric method. Data are
      presented as mean ±SD. In the statistical evaluation, p<0.05 was considered significant.

      Limitations of this study: 1) No control group, 2) No dietary restriction between sessions
      (For example, not limiting the intake of foods known to have antioxidant effects, etc.). The
      strength of this study is that it is supported by the scientific research projects
      coordinatorship of the university, which is an impartial financial resource.

      Financial support: This study was financially supported by Alanya Alaaddin Keykubat
      University (Alkü) Scientific Research Projects Coordinatorship with project number
      2021-04-02-MAP10.
    

Intervention name(s): leech therapy
Intervention type(s): Biological
Intervention description(s): effects of medicinal leeches
Intervention model: Single Group Assignment
Intervention model description: A single-group study was conducted before (1st arm) and after (2nd arm) administration of HT.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hirudotherapy; leech therapy; total antioxidative status; total oxidative status