Efficacy of Shinabro in Hand Osteoarthritis

NCT01910116 | Completed Phase 2 Results DMC

• 1 other identifier: GC6102F
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hand Osteoarthritis

Keywords

osteoarthritis; hand; Shinbaro; GCSB-5

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (35)

• AUSCAN Pain Score at 8 Weeks From Baseline

  Baseline, 8 weeks

• AUSCAN Pain Score at 12 Weeks From Baseline

  Baseline, 12 weeks

• AUSCAN Pain Score at 16 Weeks From Baseline

  Baseline and 16 weeks

• AUSCAN Stiffness at 4 Weeks Change From Baseline

  Baseline and 4 weeks

• AUSCAN Stiffness at 8 Weeks Change From Baseline

  baseline and 8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo 2 capsules, twice daily, for 12 weeks.

Drug: Placebo

Shinbaro

ACTIVE COMPARATOR

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

Drug: Shinbaro

Interventions

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

Also known as: GCSB-5

Shinbaro

Placebo DRUG

The study medication and placebo were identical in appearance.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Green Cross Corporation: collaborator

Study Sites (3)

Seoul National Univ. Bundang Hospital

Bundang, Gyeonggi-do, 463-870, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, Seoul, 156-707, South Korea

Location

Related Publications (8)

• 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.

  PMID: 24468932 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.

  PMID: 23474153 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.

  PMID: 22474519 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.

  PMID: 15094138 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.

  PMID: 22563589 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.

  PMID: 23954277 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.

  PMID: 23726390 BACKGROUND

• 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.

  PMID: 27449412 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

shinbaro

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Prof. Eun Bong Lee
• Organization: Seoul National University Hospital

leb7616@snu.ac.kr

822-2072-3944

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 29, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 17, 2015
• Results First Posted: December 17, 2015

Record last verified: 2015-08

Locations

KR (3)