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Completed

NCT Number: NCT01910116

Efficacy of Shinabro in Hand Osteoarthritis

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.

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Key information

Conditions

Hand Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National Univ. Bundang Hospital, Bundang, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: GCSB-5

Placebo

Drug

The study medication and placebo were identical in appearance.

Primary outcomes

  1. 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

Secondary outcomes

  1. AUSCAN Pain Score at 8 Weeks From Baseline

    Time frame: Baseline, 8 weeks

    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

  2. AUSCAN Pain Score at 12 Weeks From Baseline

    Time frame: Baseline, 12 weeks

    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

  3. AUSCAN Pain Score at 16 Weeks From Baseline

    Time frame: Baseline and 16 weeks

    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

  4. AUSCAN Stiffness at 4 Weeks Change From Baseline

    Time frame: Baseline and 4 weeks

    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

  5. AUSCAN Stiffness at 8 Weeks Change From Baseline

    Time frame: baseline and 8 weeks

    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

  6. AUSCAN Stiffness at 12 Weeks Change From Baseline

    Time frame: Basline and 12 weeks

    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

  7. AUSCAN Stiffness at 16 Weeks Change From Baseline

    Time frame: Baseline, 16 weeks

    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

  8. AUSCAN Function Change at 4 Weeks From Baseline

    Time frame: Basline and 4 weeks

    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

  9. AUSCAN Function Change at 8 Weeks From Baseline

    Time frame: Baseline and 8 weeks

    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

  10. AUSCAN Function Change at 12 Weeks From Baseline

    Time frame: Baseline and 12 weeks

    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

  11. AUSCAN Function Change at 16 Weeks From Baseline

    Time frame: Baseline and 16 weeks

    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

  12. Patient Global Assessment, Change From Baseline

    Time frame: Baseline and 4 weeks

    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

  13. Patient Global Assessment, Change From Baseline

    Time frame: Baseline and 8 weeks

    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

  14. Patient Global Assessment, Change From Baseline

    Time frame: Baseline and 12 weeks

    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

  15. Patient Global Assessment, Change From Baseline

    Time frame: Baseline and 16 weeks

    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

  16. Physician Global Assessment, Change From Baseline

    Time frame: baseline and 4 weeks

    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

  17. Physician Global Assessment, Change From Baseline

    Time frame: Baseline and 8 weeks

    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

  18. Physician Global Assessment, Change From Baseline

    Time frame: Baseline and 12 weeks

    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

  19. Physician Global Assessment, Change From Baseline

    Time frame: Baseline and 16 weeks

    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

  20. Tender Joint Count, Change From Baseline

    Time frame: Baseline and 4 weeks

    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

  21. Tender Joint Count, Change From Baseline

    Time frame: Baseline and 8 weeks

    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

  22. Tender Joint Count, Change From Baseline

    Time frame: Baseline and 12 weeks

    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

  23. Tender Joint Count, Change From Baseline

    Time frame: Baseline and 16 weeks

    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

  24. Swollen Joint Count, Change From Baseline

    Time frame: Baseline and 4 weeks

    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

  25. Swollen Joint Count, Change From Baseline

    Time frame: Baseline and 8 weeks

    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

  26. Swollen Joint Count, Change From Baseline

    Time frame: Baseline and 12 weeks

    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

  27. Swollen Joint Count, Change From Baseline

    Time frame: Baseline and 16 weeks

    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

  28. Acetaminophen Rescue

    Time frame: Baseline 4 weeks

    yes = AAP rescue use, no = no AAP rescue use

  29. Acetaminophen Rescue

    Time frame: 4 weeks and 8 weeks

    yes = AAP rescue use, no = no AAP rescue use

  30. Acetaminophen Rescue

    Time frame: 8 weeks and 12 weeks

    yes = AAP rescue use, no = no AAP rescue use

  31. Acetaminophen Rescue

    Time frame: 12 weeks and 16 weeks

    yes = AAP rescue use, no = no AAP rescue use

  32. Number of OMERACT-OARSI Responder

    Time frame: Baseline and 4 weeks

    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

  33. Number of OMERACT-OARSI Responder

    Time frame: Baseline and 8 weeks

    Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

  34. Number of OMERACT-OARSI Responder

    Time frame: Baseline and 12 weeks

    Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

  35. Number of OMERACT-OARSI Responder

    Time frame: Baselie and 16 weeks

    Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Green Cross Corporation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2013
Registry last updated
Dec 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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