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Efficacy of Shinabro in Hand Osteoarthritis

NCT ID: NCT01910116

Last Updated: 2015-12-17

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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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

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Hand Osteoarthritis

Keywords

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osteoarthritis hand Shinbaro GCSB-5

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo 2 capsules, twice daily, for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The study medication and placebo were identical in appearance.

Shinbaro

Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks

Group Type ACTIVE_COMPARATOR

Shinbaro

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Placebo

The study medication and placebo were identical in appearance.

Intervention Type DRUG

Other Intervention Names

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GCSB-5

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green Cross Corporation

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun Bong Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eun Bong Lee, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine

Jin Kyun Park, MD

Role: STUDY_DIRECTOR

Seoul National University Hospital

Yun Jong Lee, MD PhD

Role: STUDY_DIRECTOR

Seoul National Universty Bundang Hospital

Kichul Shin, MD PhD

Role: STUDY_DIRECTOR

SMG-SNU Boramae Medical Center

Locations

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Seoul National Univ. Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status

SMG-SNU Boramae Medical Center

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 24468932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23474153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22474519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15094138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22563589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23954277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23726390 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27449412 (View on PubMed)

Other Identifiers

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GC6102F

Identifier Type: -

Identifier Source: org_study_id