LeechesNCT05438901
Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy
A study testing leech therapy in people with Leeches, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Leeches
- What is being tested?
- leech therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,317,546 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2021to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) Not have an active bleeding problem
Who cannot join
- Bleeding diathesis (such as hemophilia)
- Pregnancy and breastfeeding status
- History of allergy to leech
- Age under 18
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alaaddin Keykubat University
Alanya, Antalya, 07400
About this study
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.
Read the 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.
- Conditions
- Leeches
- Being tested
- leech therapy
- Keywords
- Hirudotherapy, leech therapy, total antioxidative status, total oxidative status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leech therapyBiological
effects of medicinal leeches
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: leech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 0-3 months and 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start29 Mar 2021
- Primary completion29 Jun 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LeechesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single-group study was conducted before (1st arm) and after (2nd arm) administration of HT.
- Masking
- None (open label)
- Enrolment
- 12,317,546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Sarıkan, Alanya Alaaddin Keykubat University
- Investigators
- ismail sarikan, Asst.Prof., Principal investigator, Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438901
- Sponsor's protocol ID
- 123ism456kny
- Status last verified
- Jun 2022
- First submitted
- 26 Mar 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25453524Godekmerdan 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.
PubMed 22198928Erel 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.
PubMed 25304913Gultekin 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.
PubMed 30014177Sies 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.
PubMed 28441057Valko 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.
PubMed 16978905
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Oxidant-antioxidant Status in Patients Treated With Hirudotherapy
- ClinicalTrials.gov ID
- NCT05438901
- Acronym / sponsor ID
- 123ism456kny
- Conditions
- Leeches
- Keywords
- Hirudotherapy, leech therapy, total antioxidative status, total oxidative status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,317,546 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single-group study was conducted before (1st arm) and after (2nd arm) administration of HT.
| Arm | Type | Receives |
|---|---|---|
| before and after application | Experimental | Biological: leech therapyBefore 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. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Not have an active bleeding problem
Key exclusion criteria (4 listed)
- Bleeding diathesis (such as hemophilia)
- Pregnancy and breastfeeding status
- History of allergy to leech
- Age under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leech therapyeffects of medicinal leeches | Biological | before and after application |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 25453524Tagil 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.
- Background: PubMed 22198928Godekmerdan 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.
- Results publication: PubMed 25304913Erel 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.
- Results publication: PubMed 30014177Gultekin 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.
- Results publication: PubMed 28441057Sies 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.
- Results publication: PubMed 16978905Valko 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Leeches
Active, not recruiting
Effects of Hirudotherapy, Phytotherapy, and Forest Therapy in Adults With Reduced Work Capacity or Special Needs
Participation Level Below 55% and/or Special Needs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ismail sarikan, Asst.Prof. principal investigator
Alaaddin Keykubat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing leech therapy in people with Leeches, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination of the change in biochemical parameters from the beginning, TAS sample (time frame: From baseline to 0-3 months and 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05438901, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.