OsteoarthritisPhase 2NCT04108832
Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis.
A Phase 2 study testing TCM OA2 in people with Osteoarthritis, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- TCM OA2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2012to Oct 2013
- Phase
- Phase 2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years old
- Written informed consent obtained
- Been diagnosed with knee or hip osteoarthritis
- The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed
- In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week
- The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain
Who cannot join
- Pregnant or breast-feeding women.
- Chemotherapy or radiation therapy in cancer patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.
Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.
Read the detailed description
This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.
Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4.
Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.
- Conditions
- Osteoarthritis
- Being tested
- TCM OA2, PLACEBO
- Keywords
- Traditional Chinese Medicine, Herbs, Liu-wei-die-Huang-Wan
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM OA2Drug
Also called LIOW WEY DIH HUANG WAN EXTRACT PILL
Usage: 3g twice daily
PLACEBODrug
Usage: 3g twice daily
| Study group | Role | What they receive |
|---|---|---|
| TCM OA2 | Experimental | TCM OA2 3G BID FOR 8 WEEKS Receives: Drug: TCM OA2 |
| PLACEBO | Placebo comparator | PLACEBO Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities (WOMAC)
The investigators use WOMAC to compared the difference between the week 8 and week 0
Measured: week 0, week 4, week 8
Secondary outcomes (5)
Visual Analog Scale for pain (VAS)
The investigators use VAS to compared the difference between the week 4 and week 0, week 8 and week 0
Measured: week0, week 4 and 8
Physicians Global Assessment to measure quality of life (PGA)
The investigators use PGA to compared the difference between the week 4 and week 0, week 8 and week 0
Measured: week0, week 4 and week 8
Quality of life by SF-36
The investigators use SF-36 to compared the difference between the week 4 and week 0, week 2 and week 0
Measured: week0, week 2 and week 4
High sensitivity C-reactive protein (Hs-CRP)
The investigators use Hs-CRP to compared the difference between the week 8 and week 0
Measured: week0, week 8
Erythrocyte sedimentation rate (ESR)
The investigators use ESR to compared the difference between the week 8 and week 0
Measured: week0, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study startJan 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chung Wei, Chung Shan Medical University
- Investigators
- Wei C- C, M.D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108832
- Sponsor's protocol ID
- CS13048
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2014
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Formula Liu-Wei-Die-Huang-Wan in the Treatment of Osteoarthritis. An Eight-Weeks Double Blind Randomized Placebo-Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04108832
- Acronym / sponsor ID
- CS13048
- Conditions
- Osteoarthritis
- Keywords
- Traditional Chinese Medicine, Herbs, Liu-wei-die-Huang-Wan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 30 Sep 2019 (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.
Through an eight-week randomized, double-blind, placebo-controlled clinical trials formula to evaluate Chinese herbal compound OA2 improve osteoarthritis of efficacy and safety.
Detailed description
This trial was a 8 weeks' randomized, double-blind, placebo-controlled study. The study was approved by the Institutional Review Board of Chung Shan Medical University hospital, and signed informed consent was obtained from each patient. Eighty-one patients of osteoarthritis of knees or hips were enrolled in this study. Inclusion criteria were: age 20 to 80 years; primary osteoarthritis in at least 1 knee, verified radiologically and scored (as normal, minimal, moderate or marked) for joint-space narrowing and marginal osteophytes in the medial, lateral and patellofemoral compartments; at least moderate pain during the 2 weeks before random assignment to treatment, as identified with the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale.
Primary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 4.
Secondary outcome measures: WOMAC (Western Ontario and McMaster Universities) osteoarthritis index at week 2; Visual analogue scale (VAS), Quality of life by SF-36, patient global assessment (PGA), at week 2 and 4; The PGA was scored from 0 to 4 (0 representing very good); Biomarkers: Hs-CRP, ESR.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM OA2 | Experimental | Drug: TCM OA2TCM OA2 3G BID FOR 8 WEEKS |
| PLACEBO | Placebo comparator | Drug: PLACEBOPLACEBO |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥20 years old
- Written informed consent obtained
- Been diagnosed with knee or hip osteoarthritis
- The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed
- In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding women.
- Chemotherapy or radiation therapy in cancer patients
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 |
|---|---|---|
| TCM OA2Also: LIOW WEY DIH HUANG WAN EXTRACT PILLUsage: 3g twice daily | Drug | TCM OA2 |
| PLACEBOUsage: 3g twice daily | Drug | PLACEBO |
Primary outcome
Western Ontario and McMaster Universities (WOMAC)
Time frame: week 0, week 4, week 8
The investigators use WOMAC to compared the difference between the week 8 and week 0
5 secondary outcomes
Visual Analog Scale for pain (VAS)
Time frame: week0, week 4 and 8
Physicians Global Assessment to measure quality of life (PGA)
Time frame: week0, week 4 and week 8
Quality of life by SF-36
Time frame: week0, week 2 and week 4
High sensitivity C-reactive protein (Hs-CRP)
Time frame: week0, week 8
Erythrocyte sedimentation rate (ESR)
Time frame: week0, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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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.
Wei C- C, M.D. study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCM OA2 in people with Osteoarthritis, run by Chung Shan Medical University 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 30 Sep 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Western Ontario and McMaster Universities (WOMAC) (time frame: week 0, week 4, week 8). 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 30 Sep 2019.