Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy

Alanya Alaaddin Keykubat University

Status: Completed

Conditions: Leeches

Treatments: Biological: leech therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05438901

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,317,546 patients

Sex: All

Ages: 18 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12,317,546 participants in 1 patient group

before and after application

Experimental group

Description:

Before the hirudotherapy application, it was planned to study the oxidant and antioxidant parameters in the venous blood of the patient. In addition, it was planned to study the oxidant and antioxidant parameters in the patient's venous blood after 2 sessions of Hirudotherapy, 1 month apart.

Treatment:

Biological: leech therapy