- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06553313
Analysis of Protein Expression in Serum of KOA Subjects
August 11, 2024 updated by: China Medical University Hospital
Analysis of Protein Expression in Serum of Subjects With Knee Arthritis Control Group and Evaluation by Meridian and Pulse Wave Energy
In the previous study "Using omics technology to explore the mechanism of acupuncture treatment of different acupoints of knee osteoarthritis: a randomized controlled trial (CMUH109-REC3-113)", we found that acupuncture for knee osteoarthritis(KOA) significantly reduces inflammation, apoptosis, and metabolism-related serum protein profiles.
However, due to the lack of serum protein data from the control group, it is impossible to establish standard values for comparison.
To analyze the protein expression in the serum of KOA control group subjects, we also measured the spectral energy values of the radial artery pulse wave obtained from the pulse sphygmograph and the meridian energy values obtained from Ryodoraku.
The results obtained can be compared with previous studies, thus this experiment was designed.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
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 Contact
- Name: Wan-Zhen Yu
- Phone Number: 3500 8864-22053366
- Email: a030037@gmail.com
Study Contact Backup
- Name: Yu-Chen Lee
- Phone Number: 3500 8864-22053366
- Email: 005167@tool.caaumed.org.tw
Study Locations
-
-
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Taichung, Taiwan
- Recruiting
- China Medical University
-
Contact:
- Yu-Chen Lee
- Phone Number: 3500 8864-22053366
- Email: 005167@tool.caaumed.org.twv
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults over 50 years old without knee pain
Exclusion Criteria:
- Clinical diagnosis of knee osteoarthritis
- Taking anti-inflammatory and analgesic drugs in the past month
- Taking blood-lipid-lowering drugs or health foods in the past month
- Received any acupuncture treatment in the past 3 weeks
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: the control group of knee arthritis
Monitoring the stability of protein expression, pulse wave and meridian energy in the serum of the KOA control group (participants without knee pain).
|
The subjects first took the energy measurement of the pulse sphygmograph and Ryodoraku, rested for 20 minutes, and then repeated the measurements again.
In order to comply with the acupuncture treatment course was 5 weeks in the previous study, we have two blood draw point.
Each subject's blood was drawn for the first time, and then for the second time in 5 weeks later.
Each subject drew 10ml of blood each time.
The blood samples are analyzed by Micro-Western Array (MWA) and Enzyme-linked immunosorbent assay (ELISA) to obtain the serum protein content value of healthy individuals.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Micro-Western Array and Enzyme-linked immunosorbent assay
Time Frame: the first and the fifth weeks
|
Obtaining the serum protein content value
|
the first and the fifth weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pulse sphygmograph and Ryodoraku
Time Frame: the first and the fifth weeks
|
the energy measurement of pulse and meridians
|
the first and the fifth weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wan-Zhen Yu, China Medical University, China
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)
August 4, 2024
Primary Completion (Estimated)
July 23, 2025
Study Completion (Estimated)
July 23, 2025
Study Registration Dates
First Submitted
August 4, 2024
First Submitted That Met QC Criteria
August 11, 2024
First Posted (Actual)
August 14, 2024
Study Record Updates
Last Update Posted (Actual)
August 14, 2024
Last Update Submitted That Met QC Criteria
August 11, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH113-REC3-115
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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