OsteoarthritisPhase 2/3NCT04110847
Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips.
A Phase 2/3 study testing JING CEIH SHERN YUAN EXTRACT PILL in people with Osteoarthritis, run by Chung Shan Medical University.
Trial summary
To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- JING CEIH SHERN YUAN EXTRACT PILL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 22 Mar 2010to 10 Jan 2012
- Phase
- Phase 2/3
- 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
- 1. Age ≥20 years old 2. Written informed consent obtained 3. Been diagnosed with knee or hip osteoarthritis 4. The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed 5. In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week 6. The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain
Who cannot join
- 1. Pregnant or breast-feeding women. 2. Chemotherapy or radiation therapy in cancer patients
About this study
Official title: Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).
Read the detailed description
This trial was a 12 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. Sixty 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 or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.
Primary outcome measures were WOMAC at week 12.
Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and ESR.
- Conditions
- Osteoarthritis
- Being tested
- JING CEIH SHERN YUAN EXTRACT PILL
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JING CEIH SHERN YUAN EXTRACT PILLDrug
Oral use, 3#BID
| Study group | Role | What they receive |
|---|---|---|
| TCM OA1 | Active comparator | JING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day Receives: Drug: JING CEIH SHERN YUAN EXTRACT PILL |
| Placebo | Placebo comparator | Placebo 3 TABLET For 2 Times per day Receives: Drug: JING CEIH SHERN YUAN EXTRACT PILL |
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 12 and week 0
Measured: week 0, week 12
Secondary outcomes (8)
serum osteocalcin level
The investigators use serum osteocalcin level to compared the difference between week 12 and week 0
Measured: week 0, week 12
serum C-terminal telopeptide (CTX) level
The investigators use serum CTX level to compared the difference between week 12 and week 0
Measured: week 0, week 12
Western Ontario and McMaster Universities (WOMAC)
The investigators use WOMAC to compared the difference between the week 4 and week 0, week 8 and week 0
Measured: week 0, week 4, week 8
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, week 12 and week 0
Measured: week 0, week 4, week 8, week 12
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, week 12 and week 0
Measured: week 0, week 4, week 8, week 12
Quality of life by SF-36
The investigators use SF-36 to compared the difference between the week 4 and week 0, week 8 and week 0, week 12 and week 0
Measured: week 0, week 4, week 8, week 12
High sensitivity C-reactive protein (Hs-CRP)
The investigators use Hs-CRP to compared the difference between the week 12 and week 0
Measured: week 0, week 12
Erythrocyte sedimentation rate (ESR)
The investigators use ESR to compared the difference between the week 12 and week 0
Measured: week 0, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start22 Mar 2010
- Primary completion5 Dec 2011
- Study completion10 Jan 2012
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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 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
- Cheng Ching Wei, Ph. D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04110847
- Sponsor's protocol ID
- CS09165
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2019
- Last updated
- 1 Oct 2019
- 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 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Formula in the Treatment of Osteoarthritis of Knees or Hips. A Randomized Double-Blind, Placebo-Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04110847
- Acronym / sponsor ID
- CS09165
- Conditions
- Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 22 Mar 2010 (actual)
- Primary completion
- 5 Dec 2011 (actual)
- Study completion
- 10 Jan 2012 (actual)
- First posted
- 1 Oct 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.
To investigate the efficacy and safety of OA1 Extract capsules in the treatment of patients with knee or hip osteoarthritis (OA).
Detailed description
This trial was a 12 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. Sixty 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 or hip, verified; at least moderate pain during 2 weeks before random assignment to treatment, as identified by the Western Ontario and McMaster Universities (WOMAC) LK3.0 Osteoarthritis Index pain subscale for more than 4.
Primary outcome measures were WOMAC at week 12.
Secondary outcome measures were WOMAC at week 4 and 8; Visual analogue scale (VAS) , Quality of life by SF-36, patient global assessment (PGA), at week 4, 8 and 12; serum levels of osteocalcin, C-terminal telopeptide(CTX), Hs-CRP, and 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 OA1 | Active comparator | Drug: JING CEIH SHERN YUAN EXTRACT PILLJING CEIH SHERN YUAN EXTRACT PILL "CHUANG SONG ZONG" 3 TABLET For 2 Times per day |
| Placebo | Placebo comparator | Drug: JING CEIH SHERN YUAN EXTRACT PILLPlacebo 3 TABLET For 2 Times per day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥20 years old 2. Written informed consent obtained 3. Been diagnosed with knee or hip osteoarthritis 4. The physician interpretation of X-ray identification and joint space narrowing or bone spurs confirmed 5. In randomized trials before entering if used steroids or non-steroid medications osteoarthritis stable doses required at least one week 6. The WOMAC osteoarthritis index of the degree of pain assessment in the past two weeks at least> 4ppm pain
Key exclusion criteria (1 listed)
- 1. Pregnant or breast-feeding women. 2. 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 |
|---|---|---|
| JING CEIH SHERN YUAN EXTRACT PILLOral use, 3#BID | Drug | Placebo, TCM OA1 |
Primary outcome
Western Ontario and McMaster Universities (WOMAC)
Time frame: week 0, week 12
The investigators use WOMAC to compared the difference between the week 12 and week 0
8 secondary outcomes
serum osteocalcin level
Time frame: week 0, week 12
serum C-terminal telopeptide (CTX) level
Time frame: week 0, week 12
Western Ontario and McMaster Universities (WOMAC)
Time frame: week 0, week 4, week 8
Visual Analog Scale for pain (VAS)
Time frame: week 0, week 4, week 8, week 12
Physicians Global Assessment to measure quality of life (PGA)
Time frame: week 0, week 4, week 8, week 12
Quality of life by SF-36
Time frame: week 0, week 4, week 8, week 12
High sensitivity C-reactive protein (Hs-CRP)
Time frame: week 0, week 12
Erythrocyte sedimentation rate (ESR)
Time frame: week 0, week 12
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 1 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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.
Cheng Ching Wei, Ph. D. study director
Chung Shan Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing JING CEIH SHERN YUAN EXTRACT PILL in people with Osteoarthritis, run by Chung Shan Medical University.
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 1 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 1 Oct 2019. 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. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 12). 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 1 Oct 2019.