Knee OsteoarthristisNCT07072442
Integrative Chinese and Western Medicine for Knee Osteoarthritis
A study testing Western Medicine, herbal medicine and acupuncture and herbal medicine in people with Knee Osteoarthristis, run by Chang Gung Memorial Hospital.
Trial summary
This study aims to investigate if an integrated approach combining Traditional Chinese and Western medicine can better treat knee osteoarthritis. The goal is to see if this combined therapy can more effectively reduce pain severity and frequency, leading to an improved quality of life for KOA patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Western Medicine, herbal medicine and acupuncture and herbal medicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged above 18 years old
- Kellgren-lawrence grading scale ≥ II
- Numerical rating scale (NRS) ≥ 4
Who cannot join
- History of bone tumor
- Pregnancy
- History of bilateral knee replacement
- Active infection
About this study
Official title: Integrative Chinese and Western Medicine for Knee Osteoarthritis: Model of Patient Centered Healthcare and Shared Decision-making
This study aims to investigate if an integrated approach combining Traditional Chinese and Western medicine can better treat knee osteoarthritis. The goal is to see if this combined therapy can more effectively reduce pain severity and frequency, leading to an improved quality of life for KOA patients. Additionally, the study will explore the underlying mechanisms of pain and anti-inflammation related to KOA.
- Conditions
- Knee Osteoarthristis
- Being tested
- Western Medicine, herbal medicine and acupuncture, herbal medicine, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western MedicineDrug
Western medicine treatment only
herbal medicine and acupunctureProcedure or surgery
Western medicine combined acupuncture and herbal medicine treatemnt
herbal medicineDrug
Western medicine combined herbal medicine
acupunctureProcedure or surgery
western medicine combined acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Western medicine | Active comparator | Western medicine treatment only Receives: Drug: Western Medicine |
| Herbal medicine and acupuncture | Experimental | Western medicine combined herbal medicine and acupuncture Receives: Procedure: herbal medicine and acupuncture |
| herbal medicine | Experimental | Western medicine combined herbal medicine Receives: Drug: herbal medicine |
| Acupuncture | Experimental | western medicine combined acupuncture Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) subscale
Measured: From enrollment to 3 months after treatment completion.
NRS
Numerical rating scale (NRS) score for pain
Measured: From enrollment to 3 months after treatment completion.
Lequesne's index
Lequesne's index
Measured: From enrollment to 3 months after treatment completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072442
- Sponsor's protocol ID
- NMRPG8Q6021
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Chinese and Western Medicine for Knee Osteoarthritis: Model of Patient Centered Healthcare and Shared Decision-making
- ClinicalTrials.gov ID
- NCT07072442
- Acronym / sponsor ID
- NMRPG8Q6021
- Conditions
- Knee Osteoarthristis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 18 Jul 2025 (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.
This study aims to investigate if an integrated approach combining Traditional Chinese and Western medicine can better treat knee osteoarthritis. The goal is to see if this combined therapy can more effectively reduce pain severity and frequency, leading to an improved quality of life for KOA patients. Additionally, the study will explore the underlying mechanisms of pain and anti-inflammation related to KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Western medicine | Active comparator | Drug: Western MedicineWestern medicine treatment only |
| Herbal medicine and acupuncture | Experimental | Procedure: herbal medicine and acupunctureWestern medicine combined herbal medicine and acupuncture |
| herbal medicine | Experimental | Drug: herbal medicineWestern medicine combined herbal medicine |
| Acupuncture | Experimental | Procedure: acupuncturewestern medicine combined acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged above 18 years old
- Kellgren-lawrence grading scale ≥ II
- Numerical rating scale (NRS) ≥ 4
Key exclusion criteria (4 listed)
- History of bone tumor
- Pregnancy
- History of bilateral knee replacement
- Active infection
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 |
|---|---|---|
| Western MedicineWestern medicine treatment only | Drug | Western medicine |
| herbal medicine and acupunctureWestern medicine combined acupuncture and herbal medicine treatemnt | Procedure or surgery | Herbal medicine and acupuncture |
| herbal medicineWestern medicine combined herbal medicine | Drug | herbal medicine |
| acupuncturewestern medicine combined acupuncture | Procedure or surgery | Acupuncture |
Primary outcome
WOMAC
Time frame: From enrollment to 3 months after treatment completion.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) subscale
NRS
Time frame: From enrollment to 3 months after treatment completion.
Numerical rating scale (NRS) score for pain
Lequesne's index
Time frame: From enrollment to 3 months after treatment completion.
Lequesne's index
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Western Medicine, herbal medicine and acupuncture and herbal medicine in people with Knee Osteoarthristis, run by Chang Gung Memorial Hospital.
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 3 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: opening soon, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: From enrollment to 3 months after treatment completion.). The study lists 3 primary outcomes in all. 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 18 Jul 2025.