Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy

June 28, 2022 updated by: İsmail Sarıkan, Alanya Alaaddin Keykubat University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12317546

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Antalya
      • Alanya, Antalya, Turkey, 07400
        • Alaaddin Keykubat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: before and after application
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.
Biological: leech therapy
effects of medicinal leeches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examination of the change in biochemical parameters from the beginning, TAS sample
Time Frame: From baseline to 0-3 months and 3-6 months
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
Examination of the change in biochemical parameters from the beginning, TOS sample
Time Frame: From baseline to 0-3 months and 3-6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alanya Alaaddin Keykubat University

Investigators

  • Principal Investigator: ismail sarikan, Asst.Prof., Alaaddin Keykubat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

September 29, 2021

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 123ism456kny

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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