Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy

Leeches Clinical Trial

Official title:

Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05438901
• Other study ID #: 123ism456kny
• Status: Completed
• Phase: N/A
• Start date: March 29, 2021
• Est. completion date: September 29, 2021

Study information

• Verified date: June 2022
• Source: Alanya Alaaddin Keykubat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12317546
• Est. completion date: September 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Leeches

Intervention

Biological:
• leech therapy
effects of medicinal leeches

Locations

Country	Name	City	State
Turkey	Alaaddin Keykubat University	Alanya	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Alanya Alaaddin Keykubat University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Gödekmerdan 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. Review. Turkish. — View Citation

Gültekin F, Naziroglu M, Savas HB, Çig B. Calorie restriction protects against apoptosis, mitochondrial oxidative stress and increased calcium signaling through inhibition of TRPV1 channel in the hippocampus and dorsal root ganglion of rats. Metab Brain D — View Citation

Sies H, Berndt C, Jones DP. Oxidative Stress. Annu Rev Biochem. 2017 Jun 20;86:715-748. doi: 10.1146/annurev-biochem-061516-045037. Epub 2017 Apr 24. Review. — View Citation

Tagil SM, Celik HT, Ciftci S, Kazanci FH, Arslan M, Erdamar N, Kesik Y, Erdamar H, Dane S. Wet-cupping removes oxidants and decreases oxidative stress. Complement Ther Med. 2014 Dec;22(6):1032-6. doi: 10.1016/j.ctim.2014.10.008. Epub 2014 Oct 13. — View 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. Epub 2006 Aug 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Examination of the change in biochemical parameters from the beginning, TAS sample	Biochemical parameters will be measured by fully automatic colorimetric method in Alaaddin Keykubat University Faculty of Medicine Biochemistry Laboratory. TAS(Total anti-oxidant status), Unit: mmol Trolox Eq/L.Function: It is a method that measures the total antioxidant capacity of the body.	From baseline to 0-3 months and 3-6 months
Primary	Examination of the change in biochemical parameters from the beginning, TOS sample	Biochemical parameters will be measured by fully automatic colorimetric method in Alaaddin Keykubat University Faculty of Medicine Biochemistry Laboratory. TOS(Total oxidant status), Unit:µmol H2O2 Eq/L, Function: It is a colorimetric method that measures the total oxidant capacity of the body that occurs in metabolic processes.	From baseline to 0-3 months and 3-6 months

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