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| Name | Class |
|---|---|
| Green Cross Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo 2 capsules, twice daily, for 12 weeks. |
|
| Shinbaro | Active Comparator | Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shinbaro | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Baseline, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eun Bong Lee, MD PhD | Seoul National University College of Medicine | Principal Investigator |
| Jin Kyun Park, MD | Seoul National University Hospital | Study Director |
| Yun Jong Lee, MD PhD | Seoul National Universty Bundang Hospital | Study Director |
| Kichul Shin, MD PhD | SMG-SNU Boramae Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital | Bundang | Gyeonggi-do | 463-870 | South Korea | ||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24468932 | Background | 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. | |
| 23474153 | Background | Shin 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shinbaro | Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks Shinbaro |
| FG001 | Placebo | Placebo 2 capsules, twice daily, for 12 weeks. Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
1 patients in the Shinbaro group (n=110) and 3 in the placebo group (n=110) did not receive the allocated intervention as they withdrew immediately after randomization. Also, information on 1 patient in the placebo group was not complete leading to drop out.
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| ID | Title | Description |
|---|---|---|
| BG000 | Shinbaro | Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks |
| BG001 | Placebo | Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 4 weeks |
|
Any event between randomization (week 0) and study end (week 16)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Shinbaro | GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks observation for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Fracture |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Eun Bong Lee | Seoul National University Hospital | 822-2072-3944 | leb7616@snu.ac.kr |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C571726 | shinbaro |
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|
|
| Placebo | Drug | The study medication and placebo were identical in appearance. |
|
| 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).
|
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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).
| 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..
| 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..
| 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..
| 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..
| 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..
| 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..
| 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..
| 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..
| Baseline and 16 weeks |
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | Baseline 4 weeks |
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | 4 weeks and 8 weeks |
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | 8 weeks and 12 weeks |
| Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | 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 | 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 | 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 | 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 | Baselie and 16 weeks |
| Seoul |
| Seoul |
| 110-744 |
| South Korea |
| SMG-SNU Boramae Medical Center | Seoul | Seoul | 156-707 | South Korea |
| 22474519 | Background | Kim 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. |
| 15094138 | Background | Pham 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. |
| 22563589 | Background | Hochberg 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. |
| 23954277 | Background | Park 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. |
| 23726390 | Background | Coxib 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. |
| 27449412 | Derived | Park 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. |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| uncertain allocation |
|
| incomplete data |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
| Duration of OA | Mean | Standard Deviation | months |
|
| Family history of OA | Number | participants |
|
| AUSCAN pain (0-100) | Scale ranges from 0 (no pain) to 100 (the worst possible pain). | Mean | Standard Deviation | units on a scale |
|
| AUSCAN stiffness score (0-100) | Scale ranges from 0 (no stiffness) to 100 (the worst possible stiffness). | Mean | Standard Deviation | units on a scale |
|
| AUSCAN function score (0-100) | Scale ranges from 0 (no functional limitation) to 100 (the worst possible functional limitation). | Mean | Standard Deviation | units on a scale |
|
| Tender joint count | Number of tender joints on examination | Mean | Standard Deviation | Joint |
|
| Swollen joint count | Number of swollen joints on examination (i.e. number of inflammation joints) | Mean | Standard Deviation | Joint |
|
| Patient global assessment (1-100) | Patient's general condition rated by patient. The Scale ranges from 0 (excellent condition) to 100 (the worst possible condition). | Mean | Standard Deviation | units on a scale |
|
| Physician global assessment (1-100) | Patient's general condition rated by physician The Scale ranges from 0 (excellent condition) to 100 (the worst possible condition). | Mean | Standard Deviation | units on a scale |
|
| Erythrocyte sedimentation rate (ESR) | higher ESR reflects higher degree of systemic inflammation | Mean | Standard Deviation | mm/hr |
|
| C-reactive protein (CRP) | Higher CRP reflects higher systemic inflammation | Mean | Standard Deviation | mg/dL |
|
| Acetaminophen | Number of participants who were taking acetaminophen for pain management at baseline. | Number | participants |
|
| Tramadol | Number of participants who were taking tramadol for pain management at baseline | Number | participants |
|
| NSAIDs | Number of participants who were taking NSAIDs for pain management at baseline | Number | participants |
|
| Glucosamine | Number of participants who were taking glucosamine for pain management at baseline | Number | participants |
|
| Diacerin | Number of participants who were taking Diacerin for pain management at baseline | Number | participants |
|
| Others | Number of participants who were taking other OA medications for pain management at baseline. Others .. medications for OA, not mentioned above. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 8 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 12 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 16 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 4 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | baseline and 8 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Basline and 12 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 16 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Basline and 4 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 16 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 4 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 16 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | baseline and 4 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 8 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 12 weeks |
|
|
|
|
| Secondary | 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).
| Posted | Median | Inter-Quartile Range | units on a scale | Baseline and 16 weeks |
|
|
|
|
| Secondary | Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 4 weeks from baseline = TJC at 4 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | joints | Baseline and 4 weeks |
|
|
|
|
| Secondary | Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 8 weeks from baseline = TJC at 8 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | Joints | Baseline and 8 weeks |
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| Secondary | Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 12 weeks from baseline = TJC at 12 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | joints | Baseline and 12 weeks |
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| Secondary | Tender Joint Count, Change From Baseline | Change in Tender joint count (TJC) at 16 weeks from baseline = TJC at 16 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | joints | Baseline and 16 weeks |
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| Secondary | Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 4 weeks from baseline = SJC at 4 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | Joints | Baseline and 4 weeks |
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| Secondary | Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 8 weeks from baseline = SJC at 8 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | Joints | Baseline and 8 weeks |
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| Secondary | Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 12 weeks from baseline = SJC at 12 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | Joints | Baseline and 12 weeks |
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| Secondary | Swollen Joint Count, Change From Baseline | Change in Swollen joint count (SJC) at 16 weeks from baseline = SJC at 16 weeks - TJC at baseline..
| Posted | Median | Inter-Quartile Range | Joints | Baseline and 16 weeks |
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| Secondary | Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | Posted | Number | participants | Baseline 4 weeks |
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| Secondary | Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | Posted | Number | participants | 4 weeks and 8 weeks |
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| Secondary | Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | Posted | Number | participants | 8 weeks and 12 weeks |
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| Secondary | Acetaminophen Rescue | yes = AAP rescue use, no = no AAP rescue use | Posted | Number | participants | 12 weeks and 16 weeks |
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| Secondary | 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 | Posted | Number | participants | Baseline and 4 weeks |
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| Secondary | Number of OMERACT-OARSI Responder | Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Posted | Number | participants | Baseline and 8 weeks |
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| Secondary | Number of OMERACT-OARSI Responder | Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Posted | Number | participants | Baseline and 12 weeks |
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| Secondary | Number of OMERACT-OARSI Responder | Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment | Posted | Number | participants | Baselie and 16 weeks |
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| 1 |
| 109 |
| 55 |
| 109 |
| EG001 | Placebo | Placebo 2 capsules, twice daily, for 12 weeks. observation for 4 weeks | 4 | 106 | 45 | 106 |
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| Surgery | General disorders | Non-systematic Assessment | Surgery |
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| Skin rash | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| liver function abnormality | Hepatobiliary disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Paresthesia | Nervous system disorders | Non-systematic Assessment |
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| Skin rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Liver function change | Hepatobiliary disorders | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Upper respiratory infection | Immune system disorders | Non-systematic Assessment |
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| Zoster | Immune system disorders | Non-systematic Assessment |
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| Visual floater | Eye disorders | Non-systematic Assessment |
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| Depressive mood | Psychiatric disorders | Non-systematic Assessment |
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| insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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Not provided
Not provided