- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06540781
The Efficacy of Wet Cupping Therapy on Cerebral Oxygenation
Investigation of Wet Cupping Therapy Effect on Cerebral Oxygenation Levels by NIRS
The aim of this clinical trial is to investigate the efficacy of wet cupping therapy (WCT) on cerebral oxygenation using the NIRS device. With the demonstration of the positive effect of the WCT on cerebral oxygenation, it was aimed to use it effectively in stroke rehabilitation.
In the outpatient clinic setting, firstly the sensor pads of the NIRS device will be attached to the arcus superciliaris (GB14) under the tuber frontalis on both sides. After the measurement is initiated, WCT will be applied to the planum occipitale (DU 20) and to the pars squamosa (GB6-8) of the temporal bone on the sides. Measurement will continue for 10 minutes during and after the WCT application. NIRS and oxygenation measurement data will be compared before, during, and after the WCT application.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The importance of NIRS is that it can detect differences in tissue oxygen uptake that cannot be routinely identified by existing methods (24). The ability of near-infrared (NIR; near infrared; wavelength 650 - 1100nm) light to penetrate tissues and to be absorbed by some chromophores (such as haemoglobin, cytochrome oxidase, bilirubin, urobilin) has formed the basis of regional cerebral oxygen saturation (rScO2) measurement (15). NIRS is a technique in which the amount of absorption of NIR light by chromophore molecules [such as oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb), cytochrome-c oxidase (CCO), myoglobin] is measured while passing through tissues (16). rScO2 values less than 40% or changes greater than 25% from baseline values may be a harbinger of cerebral ischaemia (17). Cerebral oximetry has attracted attention because it is easy to use and uncomplicated. NIRS should be used as a trend monitor.
In the current study, it is aimed to investigate the efficacy of wet cupping therapy (WCT) on cerebral oxygenation using the NIRS device. Following the enrollment of the healthy individuals, they will all receive one session of WCT. During the WCT application, the cerebral oxygenation levels will be measured with an NIRS device.
In the outpatient clinic setting, the NIRS device's sensor pads will be attached to the arcus superciliaris (GB14) under the tuber frontalis on both sides. After the measurement is initiated, WCT will be applied to the planum occipitale (DU 20) and the pars squamosa (GB6-8) of the temporal bone on the sides. Measurement will continue for 10 minutes during and after the WCT application. The data obtained by NIRS will be compared before, during, and after the WCT application so that we will be able to find out any possible effects of WCT on cerebral oxygenation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey (Türkiye)
- Kayseri City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy individual
- Age 18-65 years
- Consent to participate
Exclusion Criteria:
- Having received cupping therapy in the past 3 months
- Contraindications for WCT (such as hemoglobin level below 9.5 g/dL, bleeding disorders, receiving antithrombotic or antiplatelet therapy, INR value above 1.5),
- Coexisting chronic conditions and using any medication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
The intervention group will receive one session of WCT.
Before, during and after the WCT application cerebral oxygenation levels will be measured by NIRS device.
|
The cupping (WCT) procedure consists of five phases: Primary suction: Using a manual suction pump, air was drawn from glass cups that were positioned on the chosen locations. The skin and subcutaneous tissue swelled as a result of the cups' five minutes of skin contact. Area disinfection: After disinfecting the cupped areas with povidone-iodine, they were wiped with sterile gauze. Scarification: Using a sterile number 11 surgical blade, superficial incisions measuring 20-30 gauge in length and 1-2 mm in depth were made on the skin. Bloodletting and secondary suction: Once again applied to the scarified areas, the previously removed cups created suction using the manual pump which was previously mentioned. In order to fill the cups, blood was drawn from the skin's and subcutaneous tissue's capillaries. Removing and dressing: After 10 minutes, the cups filled with blood were removed. The application areas were wiped with sterile gauze, and dressings were applied. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygen levels
Time Frame: Just before WCT application and 10 minutes after the application
|
Cerebral oxygenation levels measured by NIRS device
|
Just before WCT application and 10 minutes after the application
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ali R Benli, Kayseri research hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WCT-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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