HealthyNCT03503903
Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidants
A study testing Wet Cupping in people with Healthy, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant capacity of the body.The healthy volunteers will receive wet cupping application and their initial venous blood samples and samples after the treatment will be evaluated for oxidative stress. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Wet Cupping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2018to 1 Aug 2018
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults
- Must apply Traditional and complemantary medicine center for general well being.
Who cannot join
- Any chronic disorder
- Antiagregant drug usage
- Bleeding disorders
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karabuk University Karabuk Research and Education hospital
Karabük, Karabük Province, 78070
About this study
Official title: Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidant Capacity:A Self-controlled Interventional Study
This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant capacity of the body.The healthy volunteers will receive wet cupping application and their initial venous blood samples and samples after the treatment will be evaluated for oxidative stress.
Read the detailed description
Among the healthy individuals who applied for Wet Cupping Therapy (WCT) to Traditional and Complementary Therapies center in Karabuk Medical Faculty Education and Research Hospital for general wellbeing 24 volunteers were enrolled in the study. They will receive three concecutive WCT application in one month interval.Their venous blood samples obtained initially and after the completion of the three concecutive applications, will be evaluted in terms of Reactive Oxygen species and Antioxidant capacity.Additionally samples from the cupping blood during the first and the third WCT application will also be obtained and evaluated.
- Conditions
- Healthy
- Being tested
- Wet Cupping
- Keywords
- Wet cupping therapy, antioxidant capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet CuppingProcedure or surgery
CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46), which are the recommended sites for headache (12). The cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Secondary suction and bloodletting,Removing and dressing.
| Study group | Role | What they receive |
|---|---|---|
| Wet Cupping | Experimental | One armed self-controlled study. Individuals in this arm will receive three concecutive WCT application Receives: Procedure: Wet Cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
TAS
Total antioxidant status
Measured: 7 days
TOS
Total oxidant status
Measured: 7 days
Secondary outcomes (2)
SOD
Super oxide dismutase
Measured: 7 days
CAT
Catalase
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Mar 2018
- Primary completion15 Jul 2018
- Study completion1 Aug 2018
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 HealthyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULEYMAN ERSOY, Karabuk University
- Investigators
- SULEYMAN ERSOY, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503903
- Sponsor's protocol ID
- KBU-BAP-17/1-KA-070
- Status last verified
- Feb 2020
- First submitted
- 4 Apr 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
. Burton, M. Smith, T. Falkenberg, Building WHO's global strategy for traditional medicine, European Journal of Integrative Medicine 7(1) (2015) 13-15.
M. Ahmedi, M.R. Siddiqui, The value of wet cupping as a therapy in modern medicine-An Islamic Perspective, (2014).
S. El Sayed, H. Mahmoud, M. Nabo, Methods of wet cupping therapy (Al-Hijamah): in light of modern medicine and prophetic medicine, Alternative & Integrative Medicine (2013) 1-16.
Sies H. Oxidative stress: oxidants and antioxidants. Exp Physiol. 1997 Mar;82(2):291-5. doi: 10.1113/expphysiol.1997.sp004024.
PubMed 9129943Lin MT, Beal MF. Mitochondrial dysfunction and oxidative stress in neurodegenerative diseases. Nature. 2006 Oct 19;443(7113):787-95. doi: 10.1038/nature05292.
PubMed 17051205Ersoy S, Benli AR. Continue or stop applying wet cupping therapy (al-hijamah) in migraine headache:A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101065. doi: 10.1016/j.ctcp.2019.101065. Epub 2019 Oct 18.
PubMed 31668556
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidant Capacity:A Self-controlled Interventional Study
- ClinicalTrials.gov ID
- NCT03503903
- Acronym / sponsor ID
- KBU-BAP-17/1-KA-070
- Conditions
- Healthy
- Keywords
- Wet cupping therapy, antioxidant capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 20 Apr 2018 (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.
This study evaluates the efficacy of Wet cupping Therapy on oxidative stress and antioxidant capacity of the body.The healthy volunteers will receive wet cupping application and their initial venous blood samples and samples after the treatment will be evaluated for oxidative stress.
Detailed description
Among the healthy individuals who applied for Wet Cupping Therapy (WCT) to Traditional and Complementary Therapies center in Karabuk Medical Faculty Education and Research Hospital for general wellbeing 24 volunteers were enrolled in the study. They will receive three concecutive WCT application in one month interval.Their venous blood samples obtained initially and after the completion of the three concecutive applications, will be evaluted in terms of Reactive Oxygen species and Antioxidant capacity.Additionally samples from the cupping blood during the first and the third WCT application will also be obtained and evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wet Cupping | Experimental | Procedure: Wet CuppingOne armed self-controlled study. Individuals in this arm will receive three concecutive WCT application |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male adults
- Must apply Traditional and complemantary medicine center for general well being.
Key exclusion criteria (4 listed)
- Any chronic disorder
- Antiagregant drug usage
- Bleeding disorders
- -
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 |
|---|---|---|
| Wet CuppingCT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46), which are the recommended sites for headache (12). The cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Secondary suction and bloodletting,Removing and dressing. | Procedure or surgery | Wet Cupping |
Primary outcome
TAS
Time frame: 7 days
Total antioxidant status
TOS
Time frame: 7 days
Total oxidant status
2 secondary outcomes
SOD
Time frame: 7 days
CAT
Time frame: 7 days
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 20 Feb 2020.
- Background. Burton, M. Smith, T. Falkenberg, Building WHO's global strategy for traditional medicine, European Journal of Integrative Medicine 7(1) (2015) 13-15.
- BackgroundM. Ahmedi, M.R. Siddiqui, The value of wet cupping as a therapy in modern medicine-An Islamic Perspective, (2014).
- BackgroundS. El Sayed, H. Mahmoud, M. Nabo, Methods of wet cupping therapy (Al-Hijamah): in light of modern medicine and prophetic medicine, Alternative & Integrative Medicine (2013) 1-16.
- Background: PubMed 9129943Sies H. Oxidative stress: oxidants and antioxidants. Exp Physiol. 1997 Mar;82(2):291-5. doi: 10.1113/expphysiol.1997.sp004024.
- Background: PubMed 17051205Lin MT, Beal MF. Mitochondrial dysfunction and oxidative stress in neurodegenerative diseases. Nature. 2006 Oct 19;443(7113):787-95. doi: 10.1038/nature05292.
- Derived from this study: PubMed 31668556Ersoy S, Benli AR. Continue or stop applying wet cupping therapy (al-hijamah) in migraine headache:A randomized controlled trial. Complement Ther Clin Pract. 2020 Feb;38:101065. doi: 10.1016/j.ctcp.2019.101065. Epub 2019 Oct 18.
- Individual participant dataSharing planned: No
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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.
SULEYMAN ERSOY principal investigator
Karabuk 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 Wet Cupping in people with Healthy, run by Karabuk 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 2 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 20 Feb 2020. 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?
TAS (time frame: 7 days). 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 NCT03503903, 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 20 Feb 2020.