Efficacy of Shinabro in Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

Official title:

Treatment Efficacy of 'Shinbaro Capsule' in the Treatment of Hand Osteoarthritis: Randomized, Double-blinded, Placebo-controlled, Multicenter Investigator Initiated Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01910116
• Other study ID #: GC6102F
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 22, 2013
• Last updated: November 16, 2015
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: August 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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, double-blind randomized trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

Drug:
• Shinbaro
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
• Placebo
The study medication and placebo were identical in appearance.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Bundang	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 4 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline, 8 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline, 12 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 16 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 4 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	baseline and 8 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Basline and 12 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline, 16 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Basline and 4 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 8 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 12 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 16 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 4 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 8 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 12 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 16 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	baseline and 4 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 8 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 12 weeks	No
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).; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 16 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 4 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 8 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 12 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 16 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 4 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 8 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 12 weeks	No
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..; Negative value means improvement from baseline; Positive value means deterioration from baseline	Baseline and 16 weeks	No
Secondary	Acetaminophen Rescue	yes = AAP rescue use, no = no AAP rescue use	Baseline 4 weeks	No
Secondary	Acetaminophen Rescue	yes = AAP rescue use, no = no AAP rescue use	4 weeks and 8 weeks	No
Secondary	Acetaminophen Rescue	yes = AAP rescue use, no = no AAP rescue use	8 weeks and 12 weeks	No
Secondary	Acetaminophen Rescue	yes = AAP rescue use, no = no AAP rescue use	12 weeks and 16 weeks	No
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	Baseline and 4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No