OsteoarthritisPhase 3NCT01535417
Efficacy and Safety of Shinbaro Capsule
A Phase 3 study testing Shinbaro Capsule and Celebrex in people with Osteoarthritis, run by Green Cross Corporation.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Shinbaro Capsule and Celebrex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2009
- Phase
- Phase 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 35 and 80
- diagnosed with Knee OA based on criteria of ACR and showed ont through I ~ III of Kellgren Stage on radiography
- wuffered constantly with Knee OA for more than 6 months prior to begining the study
- scored more than 30 on total WOMAC scale
Who cannot join
- had other comorbid orthopedic disease
- had OA of index knee from significant trauma or surgery
About this study
Official title: A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee
The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.
- Conditions
- Osteoarthritis
- Being tested
- Shinbaro Capsule, Celebrex
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shinbaro CapsuleDrug
Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)
CelebrexDrug
| Study group | Role | What they receive |
|---|---|---|
| GCSB | Experimental | Not described Receives: Drug: Shinbaro Capsule |
| Celebrex | Active comparator | Not described Receives: Drug: Celebrex |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC change
WOMAC change
Measured: Baseline, 12 weeks
Secondary outcomes (3)
100mm Pain VAS on walking
change, percent change
Measured: Baseline, 12 weeks
PGART
Measured: 12 weeks
Adverse Events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMay 2009
- Primary completionDec 2009
- Study completionDec 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535417
- Sponsor's protocol ID
- GCSB_P3
- Status last verified
- Feb 2012
- First submitted
- 12 Feb 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee
- ClinicalTrials.gov ID
- NCT01535417
- Acronym / sponsor ID
- GCSB_P3
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Feb 2012 (estimated)
- 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.
The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCSB | Experimental | Drug: Shinbaro Capsule |
| Celebrex | Active comparator | Drug: Celebrex |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 35 and 80
- diagnosed with Knee OA based on criteria of ACR and showed ont through I ~ III of Kellgren Stage on radiography
- wuffered constantly with Knee OA for more than 6 months prior to begining the study
- scored more than 30 on total WOMAC scale
Key exclusion criteria (2 listed)
- had other comorbid orthopedic disease
- had OA of index knee from significant trauma or surgery
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 |
|---|---|---|
| Shinbaro CapsuleHerbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex) | Drug | GCSB |
| Celebrex | Drug | Celebrex |
Primary outcome
WOMAC change
Time frame: Baseline, 12 weeks
WOMAC change
3 secondary outcomes
100mm Pain VAS on walking
Time frame: Baseline, 12 weeks
PGART
Time frame: 12 weeks
Adverse Events
Time frame: 12 weeks
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 17 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Shinbaro Capsule and Celebrex in people with Osteoarthritis, run by Green Cross Corporation.
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 4 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 17 Feb 2012. 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.
What does this phase mean?
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?
WOMAC change (time frame: Baseline, 12 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 17 Feb 2012.