NCT05438901

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12,317,546

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 30, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

March 26, 2022

Last Update Submit

June 28, 2022

Conditions

Leeches

Keywords

Hirudotherapyleech therapytotal antioxidative statustotal oxidative status

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

before and after application

EXPERIMENTAL

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

Interventions

leech therapyBIOLOGICAL

effects of medicinal leeches

before and after application

Eligibility Criteria

Age18 Years - 84 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details30 women and 20 men
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Bleeding diathesis (such as hemophilia)
  • Pregnancy and breastfeeding status
  • History of allergy to leech
  • Age under 18
  • \) Not have an active bleeding problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaaddin Keykubat University

Alanya, Antalya, 07400, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 25453524BACKGROUND

  • 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.

    PMID: 22198928BACKGROUND

  • 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.

    PMID: 25304913RESULT

  • Gultekin F, Naziroglu M, Savas HB, Cig 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 Dis. 2018 Oct;33(5):1761-1774. doi: 10.1007/s11011-018-0289-0. Epub 2018 Jul 16.

    PMID: 30014177RESULT

  • 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.

    PMID: 28441057RESULT

  • 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.

    PMID: 16978905RESULT

Related Links

MeSH Terms

Interventions

Leeching

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • ismail sarikan, Asst.Prof.

    Alaaddin Keykubat University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
no masking
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A single-group study was conducted before (1st arm) and after (2nd arm) administration of HT.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.(MD, PhD)

Study Record Dates

First Submitted

March 26, 2022

First Posted

June 30, 2022

Study Start

March 29, 2021

Primary Completion

June 29, 2021

Study Completion

September 29, 2021

Last Updated

June 30, 2022

Record last verified: 2022-06

Locations

TU(1)