Clinical trial NCT05438901: Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy
Official title: Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leeches
Keywords: Hirudotherapy
leech therapy
total antioxidative status
total oxidative status
Lead sponsor: Alanya Alaaddin Keykubat University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 12317546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-group study was conducted before (1st arm) and after (2nd arm) administration of HT.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Exclusion criteria for the study:

1. Bleeding diathesis (such as hemophilia)
2. Pregnancy and breastfeeding status
3. History of allergy to leech
4. Age under 18

Inclusion criteria for the study:

1) Not have an active bleeding problem

Primary outcomes:
measure: Examination of the change in biochemical parameters from the beginning, TAS sample
timeFrame: From baseline to 0-3 months and 3-6 months
measure: Examination of the change in biochemical parameters from the beginning, TOS sample
timeFrame: From baseline to 0-3 months and 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alanya
country: Turkey
facility: Alaaddin Keykubat University
state: Antalya
Study officials:
affiliation: Alaaddin Keykubat University
name: ismail sarikan, Asst.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Godekmerdan A, Arusan S, Bayar B, Saglam N. [Medicinal leeches and hirudotherapy]. Turkiye Parazitol Derg. 2011;35(4):234-9. doi: 10.5152/tpd.2011.60. Turkish.
citation: Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem. 2014 Dec;47(18):326-32. doi: 10.1016/j.clinbiochem.2014.09.026. Epub 2014 Oct 7.
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citation: Valko M, Leibfritz D, Moncol J, Cronin MT, Mazur M, Telser J. Free radicals and antioxidants in normal physiological functions and human disease. Int J Biochem Cell Biol. 2007;39(1):44-84. doi: 10.1016/j.biocel.2006.07.001. Epub 2006 Aug 4.