Heavy Metal ToxicityNCT03693079
Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers
A study testing Wet cupping therapy in people with Heavy Metal Toxicity, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This interventional study investigates the efficacy of Wet cupping therapy on heavy metal levels.The levels of the selected heavy metals will be measured in the blood samples obtained from the participants before and after the interventions Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Metal Toxicity
- What is being tested?
- Wet cupping therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2017to 1 Oct 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Iron and Steel industry workers
Who cannot join
- having any chronic disorder
- being on daily medication
- wet cupping application in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Ersoy
Safranbolu, Karabük Province, 78070
About this study
Official title: Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers: A Self Controlled Interventional Study
This interventional study investigates the efficacy of Wet cupping therapy on heavy metal levels.The levels of the selected heavy metals will be measured in the blood samples obtained from the participants before and after the interventions
Read the detailed description
Wet cupping therapy (WCT) is a traditional therapy which was used for centuries especially for detoxifiying purposes.Current literature also points out its blood clarifiying capacity in order to illuminate the underlying mechanism of this ancient treatment.
Steel industry workers, different from the general population are exposed to heavy metals more often.Conducting a study in this special group where we will evaluate the levels of selected heavy metals in blood before and after the three sessions of WCT might let us know its detoxifiying capacity based on measurable parameters.
- Conditions
- Heavy Metal Toxicity
- Being tested
- Wet cupping therapy
- Keywords
- heavy metal, wet cupping therapy, steel industry worker
- Medical subject headings
- Heavy Metal Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wet cupping therapyProcedure 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). The cupping technique procedure was conducted in five phases:
- Primary suction; cups are left attached to the skin for 5 minutes.
- Area disinfection; areas are wiped with sterile gauze after disinfection with povidone iodine.
- Scarification; Superficial incisions (20-30 gauge), 5 mm length and 1-2 mm depth, are made on the skin with a sterile, number 11 surgical blade.
- Bloodletting and secondary suction; the cups which had been previously removed are placed again on the scarified areas Blood leaks from the capillary vessels of the skin and subcutaneous tissue and fills the cups, which are left in place for 15 minutes.
- Removing and dressing; the cups full of blood are removed. The areas of application are wiped with sterile gauze and then a dressing is applied
| Study group | Role | What they receive |
|---|---|---|
| Wet Cupping | Experimental | wet cupping therapy will be applied to all participants Receives: Procedure: Wet cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of the selected heavy metals in venous blood samples before and after the interventions
the levels of the calculated heavy metals will be in ppm
Measured: 3 months
Secondary outcomes (1)
Levels of the selected heavy metals in cupping blood samples obtained during the first intervention
the levels of the calculated heavy metals will be in ppm
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start3 Sep 2017
- Primary completion1 Aug 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Metal ToxicityStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SULEYMAN ERSOY, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693079
- Sponsor's protocol ID
- KBU-BAP-17/1-KA-071
- Status last verified
- Jul 2018
- First submitted
- 30 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers: A Self Controlled Interventional Study
- ClinicalTrials.gov ID
- NCT03693079
- Acronym / sponsor ID
- KBU-BAP-17/1-KA-071
- Conditions
- Heavy Metal Toxicity
- Keywords
- heavy metal, wet cupping therapy, steel industry worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 3 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 2 Oct 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 interventional study investigates the efficacy of Wet cupping therapy on heavy metal levels.The levels of the selected heavy metals will be measured in the blood samples obtained from the participants before and after the interventions
Detailed description
Wet cupping therapy (WCT) is a traditional therapy which was used for centuries especially for detoxifiying purposes.Current literature also points out its blood clarifiying capacity in order to illuminate the underlying mechanism of this ancient treatment.
Steel industry workers, different from the general population are exposed to heavy metals more often.Conducting a study in this special group where we will evaluate the levels of selected heavy metals in blood before and after the three sessions of WCT might let us know its detoxifiying capacity based on measurable parameters.
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 cupping therapywet cupping therapy will be applied to all participants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- Iron and Steel industry workers
Key exclusion criteria (3 listed)
- having any chronic disorder
- being on daily medication
- wet cupping application in the last 6 months
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 cupping therapyCT 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). The cupping technique procedure was conducted in five phases: 1. Primary suction; cups are left attached to the skin for 5 minutes. 2. Area disinfection; areas are wiped with sterile gauze after disinfection with povidone iodine. 3. Scarification; Superficial incisions (20-30 gauge), 5 mm length and 1-2 mm depth, are made on the skin with a sterile, number 11 surgical blade. 4. Bloodletting and secondary suction; the cups which had been previously removed are placed again on the scarified areas Blood leaks from the capillary vessels of the skin and subcutaneous tissue and fills the cups, which are left in place for 15 minutes. 5. Removing and dressing; the cups full of blood are removed. The areas of application are wiped with sterile gauze and then a dressing is applied | Procedure or surgery | Wet Cupping |
Primary outcome
Levels of the selected heavy metals in venous blood samples before and after the interventions
Time frame: 3 months
the levels of the calculated heavy metals will be in ppm
1 secondary outcome
Levels of the selected heavy metals in cupping blood samples obtained during the first intervention
Time frame: 1 month
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 2 Oct 2018.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy in people with Heavy Metal Toxicity, 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 3 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 2 Oct 2018. 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?
Levels of the selected heavy metals in venous blood samples before and after the interventions (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.