Hand OsteoarthritisPhase 2/3NCT01910116
Efficacy of Shinabro in Hand Osteoarthritis
A Phase 2/3 study testing Shinbaro in people with Hand Osteoarthritis, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Shinbaro
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Sep 2013to Nov 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age of 40 years or older
- Osteoarthritis according to ACR 1990 criteria
- Mean joint visual analog pain score (VAS) > 30mm in the preceding 48 hours
- Patients who are will to participate
Who cannot join
- Any prior surgery of hand joints
- prior history of Shinbaro use
- Intra-articular injection of glucocorticosteroid or hyaluronic acid in the preceding 3 months
- Pregnancy or active breast feeding
- Prior hypersensitivity reaction to herbal medications
- AST or ALT elevation > 3 of upper normal limit
Show all 10Show fewer
- GRF (MDRD) < 30 mg/min/1.73m2
- Nephrotic syndrome, other signficant kidney disease
- Patients who seem not to tolerate the study at investigator's discretion
- Patients who refuse to participate
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National Univ. Bundang Hospital
Bundang, Gyeonggi-do, 463-870
Seoul National University Hospital
Seoul, Seoul, 110-744
SMG-SNU Boramae Medical Center
Seoul, Seoul, 156-707
About this study
Official title: Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.
GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.
Read the detailed description
Osteoarthritis (OA) as a common musculoskeletal disease affects more than 30% of the elderly population. It frequently involves knees, hips, spines and hands. In hands, the distal and proximal interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. The chronic progressive nature of the disease requires a life-long treatment. The mainstay treatment of hand OA targets pain control. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used. However, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. Further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics.
Shibaro is a mixture of purified oriental herbs consisting of Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex. These herbs have been used for the treatment of diverse inflammatory conditions in Chines traditional medicine. All 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. As such, given the excellent safety profile, anti-inflammatory and analgesic effects, Shinbaro might be ideal in the treatment of OA.
This study will investigate the efficacy and safety of Shinbaro in the treatment of hand OA in a placebo-controlled, randomized, double-blind, multi-center trial.
- Conditions
- Hand Osteoarthritis
- Being tested
- Shinbaro, Placebo
- Keywords
- osteoarthritis, hand, Shinbaro, GCSB-5
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShinbaroDrug
Also called GCSB-5
GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem
PlaceboDrug
The study medication and placebo were identical in appearance.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 2 capsules, twice daily, for 12 weeks. Receives: Drug: Placebo |
| Shinbaro | Active comparator | Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks Receives: Drug: Shinbaro |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUSCAN Pain Change at 4 Weeks From Baseline
Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100).
AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 4 weeks
Secondary outcomes (35)
AUSCAN Pain Score at 8 Weeks From Baseline
Change in AUSCAN pain score at 8 weeks from baseline = Pain at 8 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline, 8 weeks
AUSCAN Pain Score at 12 Weeks From Baseline
Change in AUSCAN pain score at 12 weeks from baseline = Pain at 12 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline, 12 weeks
AUSCAN Pain Score at 16 Weeks From Baseline
Change in AUSCAN pain score at 16 weeks from baseline = Pain at 16 weeks (0-100)- Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 16 weeks
AUSCAN Stiffness at 4 Weeks Change From Baseline
Change in AUSCAN stiffness score at 4 weeks from baseline = Stiffness at 4 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 4 weeks
AUSCAN Stiffness at 8 Weeks Change From Baseline
Change in AUSCAN stiffness score at 8 weeks from baseline = Stiffness at 8 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: baseline and 8 weeks
AUSCAN Stiffness at 12 Weeks Change From Baseline
Change in AUSCAN stiffness score at 12 weeks from baseline = Stiffness at 12 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Basline and 12 weeks
AUSCAN Stiffness at 16 Weeks Change From Baseline
Change in AUSCAN stiffness score at 16 weeks from baseline = Stiffness at 16 weeks (0-100)- Stiffness at baseline (0-100). AUSCAN Stiffness scale ranges from 0 (no stiffness) to 100 (worst possible stiffness).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline, 16 weeks
AUSCAN Function Change at 4 Weeks From Baseline
Change in AUSCAN function score at 4 weeks from baseline = Function score at 4 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Basline and 4 weeks
AUSCAN Function Change at 8 Weeks From Baseline
Change in AUSCAN function score at 8 weeks from baseline = Function score at 8 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 8 weeks
AUSCAN Function Change at 12 Weeks From Baseline
Change in AUSCAN function score at 12 weeks from baseline = Function score at 12 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 12 weeks
AUSCAN Function Change at 16 Weeks From Baseline
Change in AUSCAN function score at 16 weeks from baseline = Function score at 16 weeks (0-100)- Function score at baseline (0-100). AUSCAN Function score scale ranges from 0 (no functional limitation) to 100 (worst possible functional limitation).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 16 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 4 weeks from baseline = PGA at 4 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 4 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 8 weeks from baseline = PGA at 8 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 8 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 12 weeks from baseline = PGA at 12 weeks (0-100)- PGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 12 weeks
Patient Global Assessment, Change From Baseline
Change in Patient global assessment (PGA) at 16 weeks from baseline = PGA at 16 weeks (0-100)- PGA score at baseline (0-100). PGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 16 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 4 weeks from baseline = PhGA at 4 weeks (0-100)- PhGA score at baseline (0-100). GPA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: baseline and 4 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 8 weeks from baseline = PhGA at 8 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 8 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 12 weeks from baseline = PhGA at 12 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 12 weeks
Physician Global Assessment, Change From Baseline
Change in Physician global assessment (PhGA) at 16 weeks from baseline = PhGA at 16 weeks (0-100)- PhGA score at baseline (0-100). PhGA scale ranges from 0 (excellent condition) to 100 (worst possible worse possible condition).
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 16 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 4 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 8 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 12 weeks
Tender Joint Count, Change From Baseline
Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 16 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 4 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 8 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 12 weeks
Swollen Joint Count, Change From Baseline
Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline..
- Negative value means improvement from baseline
- Positive value means deterioration from baseline
Measured: Baseline and 16 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Measured: Baseline 4 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Measured: 4 weeks and 8 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Measured: 8 weeks and 12 weeks
Acetaminophen Rescue
yes = AAP rescue use, no = no AAP rescue use
Measured: 12 weeks and 16 weeks
Number of OMERACT-OARSI Responder
Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Measured: Baseline and 4 weeks
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Measured: Baseline and 8 weeks
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Measured: Baseline and 12 weeks
Number of OMERACT-OARSI Responder
Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
Measured: Baselie and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Seoul National 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
- Investigators
- Eun Bong Lee, MD PhD, Principal investigator, Seoul National University College of MedicineJin Kyun Park, MD, Study director, Seoul National University HospitalYun Jong Lee, MD PhD, Study director, Seoul National Universty Bundang HospitalKichul Shin, MD PhD, Study director, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910116
- Sponsor's protocol ID
- GC6102F
- Status last verified
- Aug 2015
- First submitted
- 22 Jul 2013
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kloppenburg M. Hand osteoarthritis-nonpharmacological and pharmacological treatments. Nat Rev Rheumatol. 2014 Apr;10(4):242-51. doi: 10.1038/nrrheum.2013.214. Epub 2014 Jan 28.
PubMed 24468932Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.
PubMed 23474153Kim JK, Park SW, Kang JW, Kim YJ, Lee SY, Shin J, Lee S, Lee SM. Effect of GCSB-5, a Herbal Formulation, on Monosodium Iodoacetate-Induced Osteoarthritis in Rats. Evid Based Complement Alternat Med. 2012;2012:730907. doi: 10.1155/2012/730907. Epub 2012 Mar 4.
PubMed 22474519Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001.
PubMed 15094138Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
PubMed 22563589Park YG, Ha CW, Han CD, Bin SI, Kim HC, Jung YB, Lim HC. A prospective, randomized, double-blind, multicenter comparative study on the safety and efficacy of Celecoxib and GCSB-5, dried extracts of six herbs, for the treatment of osteoarthritis of knee joint. J Ethnopharmacol. 2013 Oct 7;149(3):816-24. doi: 10.1016/j.jep.2013.08.008. Epub 2013 Aug 14.
PubMed 23954277Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.
PubMed 23726390Park JK, Shin K, Kang EH, Ha YJ, Lee YJ, Lee KH, Lee EY, Song YW, Choi Y, Lee EB. Efficacy and Tolerability of GCSB-5 for Hand Osteoarthritis: A Randomized, Controlled Trial. Clin Ther. 2016 Aug;38(8):1858-1868.e2. doi: 10.1016/j.clinthera.2016.06.016. Epub 2016 Jul 21.
PubMed 27449412
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.
- ClinicalTrials.gov ID
- NCT01910116
- Acronym / sponsor ID
- GC6102F
- Conditions
- Hand Osteoarthritis
- Keywords
- osteoarthritis, hand, Shinbaro, GCSB-5
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Jul 2013 (estimated)
- Results
- Posted 17 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GCSB-5 ("Shinbaro capsule"), is a mixture of 6 oriental herbs that have anti-inflammatory and analgesic effects along with an excellent safety profile. This study is aimed at investigating efficacy of Shinbaro in the treatment of hand osteoarthritis which needs a long term treatment in a placebo controlled, double-blind randomized trial.
Detailed description
Osteoarthritis (OA) as a common musculoskeletal disease affects more than 30% of the elderly population. It frequently involves knees, hips, spines and hands. In hands, the distal and proximal interphalangeal and the first carpometacarpal joints are affected, leading often to significant disability and limitation in the daily activity. The chronic progressive nature of the disease requires a life-long treatment. The mainstay treatment of hand OA targets pain control. Non-steroidal anti-inflammatory drugs (NSAIDs) are often used. However, they are frequently associated with significant gastrointestinal side effects including gastritis, peptic ulcer diseases, and bleeding, especially with long term use. Further, they do not ameliorate pain completely, requiring additional medications such as acetaminophen or opioid-based analgesics.
Shibaro is a mixture of purified oriental herbs consisting of Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, and Eucommiae Cortex. These herbs have been used for the treatment of diverse inflammatory conditions in Chines traditional medicine. All 6 herbs show an excellent safety profile and their anti-inflammatory and analgesic effects have been studied in both animals and humans. As such, given the excellent safety profile, anti-inflammatory and analgesic effects, Shinbaro might be ideal in the treatment of OA.
This study will investigate the efficacy and safety of Shinbaro in the treatment of hand OA in a placebo-controlled, randomized, double-blind, multi-center trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2 capsules, twice daily, for 12 weeks. |
| Shinbaro | Active comparator | Drug: ShinbaroShinbaro, 2 capsules (300mg), twice daily, for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 40 years or older
- Osteoarthritis according to ACR 1990 criteria
- Mean joint visual analog pain score (VAS) > 30mm in the preceding 48 hours
- Patients who are will to participate
Key exclusion criteria (10 listed)
- Any prior surgery of hand joints
- prior history of Shinbaro use
- Intra-articular injection of glucocorticosteroid or hyaluronic acid in the preceding 3 months
- Pregnancy or active breast feeding
- Prior hypersensitivity reaction to herbal medications
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 |
|---|---|---|
| ShinbaroAlso: GCSB-5GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem | Drug | Shinbaro |
| PlaceboThe study medication and placebo were identical in appearance. | Drug | Placebo |
Primary outcome
AUSCAN Pain Change at 4 Weeks From Baseline
Time frame: Baseline and 4 weeks
Change in AUSCAN pain score at 4 weeks from baseline = Pain at 4 weeks (0-100) - Pain at baseline (0-100). AUSCAN Pain scale ranges from 0 (no pain) to 100 (worst possible pain). * Negative value means improvement from baseline * Positive value means deterioration from baseline
35 secondary outcomes
AUSCAN Pain Score at 8 Weeks From Baseline
Time frame: Baseline, 8 weeks
AUSCAN Pain Score at 12 Weeks From Baseline
Time frame: Baseline, 12 weeks
AUSCAN Pain Score at 16 Weeks From Baseline
Time frame: Baseline and 16 weeks
AUSCAN Stiffness at 4 Weeks Change From Baseline
Time frame: Baseline and 4 weeks
AUSCAN Stiffness at 8 Weeks Change From Baseline
Time frame: baseline and 8 weeks
AUSCAN Stiffness at 12 Weeks Change From Baseline
Time frame: Basline and 12 weeks
AUSCAN Stiffness at 16 Weeks Change From Baseline
Time frame: Baseline, 16 weeks
AUSCAN Function Change at 4 Weeks From Baseline
Time frame: Basline and 4 weeks
AUSCAN Function Change at 8 Weeks From Baseline
Time frame: Baseline and 8 weeks
AUSCAN Function Change at 12 Weeks From Baseline
Time frame: Baseline and 12 weeks
AUSCAN Function Change at 16 Weeks From Baseline
Time frame: Baseline and 16 weeks
Patient Global Assessment, Change From Baseline
Time frame: Baseline and 4 weeks
Patient Global Assessment, Change From Baseline
Time frame: Baseline and 8 weeks
Patient Global Assessment, Change From Baseline
Time frame: Baseline and 12 weeks
Patient Global Assessment, Change From Baseline
Time frame: Baseline and 16 weeks
Physician Global Assessment, Change From Baseline
Time frame: baseline and 4 weeks
Physician Global Assessment, Change From Baseline
Time frame: Baseline and 8 weeks
Physician Global Assessment, Change From Baseline
Time frame: Baseline and 12 weeks
Physician Global Assessment, Change From Baseline
Time frame: Baseline and 16 weeks
Tender Joint Count, Change From Baseline
Time frame: Baseline and 4 weeks
Tender Joint Count, Change From Baseline
Time frame: Baseline and 8 weeks
Tender Joint Count, Change From Baseline
Time frame: Baseline and 12 weeks
Tender Joint Count, Change From Baseline
Time frame: Baseline and 16 weeks
Swollen Joint Count, Change From Baseline
Time frame: Baseline and 4 weeks
Swollen Joint Count, Change From Baseline
Time frame: Baseline and 8 weeks
Swollen Joint Count, Change From Baseline
Time frame: Baseline and 12 weeks
Swollen Joint Count, Change From Baseline
Time frame: Baseline and 16 weeks
Acetaminophen Rescue
Time frame: Baseline 4 weeks
Acetaminophen Rescue
Time frame: 4 weeks and 8 weeks
Acetaminophen Rescue
Time frame: 8 weeks and 12 weeks
Acetaminophen Rescue
Time frame: 12 weeks and 16 weeks
Number of OMERACT-OARSI Responder
Time frame: Baseline and 4 weeks
Number of OMERACT-OARSI Responder
Time frame: Baseline and 8 weeks
Number of OMERACT-OARSI Responder
Time frame: Baseline and 12 weeks
Number of OMERACT-OARSI Responder
Time frame: Baselie and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24468932Kloppenburg M. Hand osteoarthritis-nonpharmacological and pharmacological treatments. Nat Rev Rheumatol. 2014 Apr;10(4):242-51. doi: 10.1038/nrrheum.2013.214. Epub 2014 Jan 28.
- Background: PubMed 23474153Shin K, Kim JW, Moon KW, Yang JA, Lee EY, Song YW, Lee EB. The efficacy of diacerein in hand osteoarthritis: a double-blind, randomized, placebo-controlled study. Clin Ther. 2013 Apr;35(4):431-9. doi: 10.1016/j.clinthera.2013.02.009. Epub 2013 Mar 6.
- Background: PubMed 22474519Kim JK, Park SW, Kang JW, Kim YJ, Lee SY, Shin J, Lee S, Lee SM. Effect of GCSB-5, a Herbal Formulation, on Monosodium Iodoacetate-Induced Osteoarthritis in Rats. Evid Based Complement Alternat Med. 2012;2012:730907. doi: 10.1155/2012/730907. Epub 2012 Mar 4.
- Background: PubMed 15094138Pham T, van der Heijde D, Altman RD, Anderson JJ, Bellamy N, Hochberg M, Simon L, Strand V, Woodworth T, Dougados M. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage. 2004 May;12(5):389-99. doi: 10.1016/j.joca.2004.02.001.
- Background: PubMed 22563589Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
- Background: PubMed 23954277Park YG, Ha CW, Han CD, Bin SI, Kim HC, Jung YB, Lim HC. A prospective, randomized, double-blind, multicenter comparative study on the safety and efficacy of Celecoxib and GCSB-5, dried extracts of six herbs, for the treatment of osteoarthritis of knee joint. J Ethnopharmacol. 2013 Oct 7;149(3):816-24. doi: 10.1016/j.jep.2013.08.008. Epub 2013 Aug 14.
- Background: PubMed 23726390Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.
- Derived from this study: PubMed 27449412Park JK, Shin K, Kang EH, Ha YJ, Lee YJ, Lee KH, Lee EY, Song YW, Choi Y, Lee EB. Efficacy and Tolerability of GCSB-5 for Hand Osteoarthritis: A Randomized, Controlled Trial. Clin Ther. 2016 Aug;38(8):1858-1868.e2. doi: 10.1016/j.clinthera.2016.06.016. Epub 2016 Jul 21.
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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.
Eun Bong Lee, MD PhD principal investigator
Seoul National University College of Medicine
Jin Kyun Park, MD study director
Seoul National University Hospital
Yun Jong Lee, MD PhD study director
Seoul National Universty Bundang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Shinbaro in people with Hand Osteoarthritis, run by Seoul National University Hospital at 3 sites in South Korea.
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 10 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 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?
Yes. Results are posted in the registry (first posted 17 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUSCAN Pain Change at 4 Weeks From Baseline (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01910116, which also lists 8 linked publications.
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 Dec 2015.