Leeches Clinical Trial
Official title:
Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy
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.
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. ;
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