NCT03693079

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
Last Updated

October 2, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

September 30, 2018

Last Update Submit

September 30, 2018

Conditions

Keywords

heavy metalwet cupping therapysteel industry worker

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Secondary Outcomes (1)

  • Levels of the selected heavy metals in cupping blood samples obtained during the first intervention

    1 month

Study Arms (1)

Wet Cupping

EXPERIMENTAL

wet cupping therapy will be applied to all participants

Procedure: Wet cupping therapy

Interventions

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: 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

Wet Cupping

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals
  • Iron and Steel industry workers

You may not qualify if:

  • having any chronic disorder
  • being on daily medication
  • wet cupping application in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suleyman Ersoy

Safranbolu, Karabük Province, 78070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heavy Metal Poisoning

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof. Department of Family Medicine

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 2, 2018

Study Start

September 3, 2017

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-07

Locations