- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03503903
Efficacy of Wet Cupping on Reactive Oxygen Species and Antioxidants
February 18, 2020 updated by: SULEYMAN ERSOY, Karabuk University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Karabuk
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Karabük, Karabuk, Turkey, 78070
- Karabuk University Karabuk Research and Education hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Healthy male adults
Must apply Traditional and complemantary medicine center for general well being.
Exclusion Criteria:
Any chronic disorder
Antiagregant drug usage
Bleeding disorders
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Wet Cupping
One armed self-controlled study.
Individuals in this arm will receive three concecutive WCT application
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TAS
Time Frame: 7 days
|
Total antioxidant status
|
7 days
|
TOS
Time Frame: 7 days
|
Total oxidant status
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SOD
Time Frame: 7 days
|
Super oxide dismutase
|
7 days
|
CAT
Time Frame: 7 days
|
Catalase
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lin MT, Beal MF. Mitochondrial dysfunction and oxidative stress in neurodegenerative diseases. Nature. 2006 Oct 19;443(7113):787-95. doi: 10.1038/nature05292.
- Ersoy 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2018
Primary Completion (ACTUAL)
July 15, 2018
Study Completion (ACTUAL)
August 1, 2018
Study Registration Dates
First Submitted
April 4, 2018
First Submitted That Met QC Criteria
April 11, 2018
First Posted (ACTUAL)
April 20, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 20, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KBU-BAP-17/1-KA-070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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