Efficacy of Shinabro in Hand Osteoarthritis

Phase 2

Completed

• Conditions: Hand Osteoarthritis
• Interventions: Drug: Placebo; Drug: Shinbaro

• Registration Number: NCT01910116
• Lead Sponsor: Seoul National University Hospital

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-29
• Study Start: 2013-09
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2015-02-28
• Status Verified: 2015-08
• Results First Submitted QC: 2015-11-16
• Last Update Submitted: 2015-11-16
• Results First Posted: 2015-12-17
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 2 capsules, twice daily, for 12 weeks.
Shinbaro	Shinbaro	Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks

Primary Outcome Measures

Name	Time	Method
AUSCAN Pain Change at 4 Weeks From Baseline	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 Outcome Measures

Name	Time	Method
AUSCAN Pain Score at 8 Weeks From Baseline	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
AUSCAN Function Change at 12 Weeks From Baseline	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
Acetaminophen Rescue	12 weeks and 16 weeks	yes = AAP rescue use, no = no AAP rescue use
AUSCAN Function Change at 16 Weeks From Baseline	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
Number of OMERACT-OARSI Responder	Baselie and 16 weeks	Number of patients who met OMERACT-OARSI criteria = significant clinical improvement in osteoarthritis symptom after treatment
AUSCAN Pain Score at 12 Weeks From Baseline	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
AUSCAN Stiffness at 4 Weeks Change From Baseline	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
AUSCAN Stiffness at 8 Weeks Change From Baseline	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
AUSCAN Stiffness at 12 Weeks Change From Baseline	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
AUSCAN Function Change at 4 Weeks From Baseline	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
AUSCAN Pain Score at 16 Weeks From Baseline	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
AUSCAN Stiffness at 16 Weeks Change From Baseline	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
AUSCAN Function Change at 8 Weeks From Baseline	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
Patient Global Assessment, Change From Baseline	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
Physician Global Assessment, Change From Baseline	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
Tender Joint Count, Change From Baseline	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
Swollen Joint Count, Change From Baseline	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

Trial Locations

Locations (3)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National Univ. Bundang Hospital; 🇰🇷 Bundang, Gyeonggi-do, Korea, Republic of