Knee OsteoarthritisNCT06553313
Analysis of Protein Expression in Serum of KOA Subjects
A study testing Micro-Western Array in people with Knee Osteoarthritis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Micro-Western Array
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2024to 23 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over 50 years old without knee pain
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University
Taichung
Yu-Chen Lee, 8864-22053366 ext. 3500, 005167@tool.caaumed.org.twv
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Micro-Western Array
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-Western ArrayDevice
Also called Enzyme-linked immunosorbent assay, pulse sphygmograph, Ryodoraku
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.
| Study group | Role | What they receive |
|---|---|---|
| the control group of knee arthritis | Other | Monitoring the stability of protein expression, pulse wave and meridian energy in the serum of the KOA control group (participants without knee pain). Receives: Device: Micro-Western Array |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micro-Western Array and Enzyme-linked immunosorbent assay
Obtaining the serum protein content value
Measured: the first and the fifth weeks
Secondary outcomes (1)
pulse sphygmograph and Ryodoraku
the energy measurement of pulse and meridians
Measured: the first and the fifth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start4 Aug 2024
- Primary completion23 Jul 2025 (estimated)
- Study completion23 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wan-Zhen Yu, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553313
- Sponsor's protocol ID
- CMUH113-REC3-115
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Protein Expression in Serum of Subjects With Knee Arthritis Control Group and Evaluation by Meridian and Pulse Wave Energy
- ClinicalTrials.gov ID
- NCT06553313
- Acronym / sponsor ID
- CMUH113-REC3-115
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 23 Jul 2025 (estimated)
- Study completion
- 23 Jul 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the control group of knee arthritis | Other | Device: Micro-Western ArrayMonitoring the stability of protein expression, pulse wave and meridian energy in the serum of the KOA control group (participants without knee pain). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults over 50 years old without knee pain
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-Western ArrayAlso: Enzyme-linked immunosorbent assay, pulse sphygmograph, RyodorakuThe 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. | Device | the control group of knee arthritis |
Primary outcome
Micro-Western Array and Enzyme-linked immunosorbent assay
Time frame: the first and the fifth weeks
Obtaining the serum protein content value
1 secondary outcome
pulse sphygmograph and Ryodoraku
Time frame: the first and the fifth weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan-Zhen Yu principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-Western Array in people with Knee Osteoarthritis, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Zhen Yu (8864-22053366 ext. 3500, a030037@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micro-Western Array and Enzyme-linked immunosorbent assay (time frame: the first and the fifth weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.