## Protocol Section
### Identification Module
**NCT ID:** NCT03693079

**Brief Title:** Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers

**Official Title:** Investigation of Wet Cupping Therapy on Heavy Metal Levels of Steel Industry Workers: A Self Controlled Interventional Study

#### Organization Study ID Info
**ID:** KBU-BAP-17/1-KA-071
#### Organization
**Class:** OTHER
**Full Name:** Karabuk University
### Status Module
#### Completion Date
**Date:** 2018-10-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-02

**Type:** ACTUAL

**Last Update Submit Date:** 2018-09-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-08-01

**Type:** ACTUAL

#### Start Date
**Date:** 2017-09-03

**Type:** ACTUAL

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2018-10-02
**Type:** ACTUAL
**Study First Submit Date:** 2018-09-30
**Study First Submit QC Date:** 2018-09-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karabuk University

#### Responsible Party

**Investigator Affiliation:** Karabuk University

**Investigator Full Name:** SULEYMAN ERSOY

**Investigator Title:** Assist.Prof. Department of Family Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

**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 Module

**Conditions:**

- Heavy Metal Toxicity

**Keywords:**

- heavy metal

- wet cupping therapy

- steel industry worker

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 44

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** wet cupping therapy will be applied to all participants

**Intervention Names:**

- Procedure: Wet cupping therapy

**Label:** Wet Cupping

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Wet Cupping

**Description:** 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

**Name:** Wet cupping therapy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** the levels of the calculated heavy metals will be in ppm

**Measure:** Levels of the selected heavy metals in venous blood samples before and after the interventions

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** the levels of the calculated heavy metals will be in ppm

**Measure:** Levels of the selected heavy metals in cupping blood samples obtained during the first intervention

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy individuals
* Iron and Steel industry workers

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Safranbolu

**Country:** Turkey

**Facility:** Suleyman Ersoy

**State:** Karabuk

**Zip:** 78070

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011041

- Term: Poisoning

- ID: D000064419

- Term: Chemically-Induced Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC25

- Name: Substance Related Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M1480

- Name: Heavy Metal Poisoning

- Relevance: HIGH

- As Found: Heavy Metal Toxicity

- ID: M13931

- Name: Poisoning

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2680

- Name: Heavy Metal Poisoning

- Relevance: HIGH

- As Found: Heavy Metal Toxicity

### Condition Browse Module - Meshes

- ID: D000075322

- Term: Heavy Metal Poisoning

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BlSubst

- Name: Blood Substitutes

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M14088

- Name: Povidone-Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M14087

- Name: Povidone

- Relevance: LOW

- As Found: Unknown

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
