Efficacy and Safety of Shinbaro Capsule

A 12 Weeks, Randomized, Double-blind, Multi-centers, Phase III Study to Evaluate the Efficacy and Safety of Shinbaro Capsule Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01535417

Enrollment

198

Registered

2012-02-17

Start date

2009-05-31

Completion date

2009-12-31

Last updated

2012-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis

Brief summary

The purpose of this study is to evaluate the efficacy and safety of 'Shinbaro Capsule', a new herbal anti-arthritic agent, in patients with osteoarthritis of the knee.

Interventions

DRUGShinbaro Capsule

Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)

DRUGCelebrex

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

Healthy volunteers

Inclusion criteria

* age between 35 and 80 * diagnosed with Knee OA based on criteria of ACR and showed ont through I \ III of Kellgren Stage on radiography * wuffered constantly with Knee OA for more than 6 months prior to begining the study * scored more than 30 on total WOMAC scale

Exclusion criteria

* had other comorbid orthopedic disease * had OA of index knee from significant trauma or surgery

Design outcomes

Primary

Measure	Time frame	Description
WOMAC change	Baseline, 12 weeks	WOMAC change

Secondary

Measure	Time frame	Description
100mm Pain VAS on walking	Baseline, 12 weeks	change, percent change
PGART	12 weeks	—
Adverse Events	12 weeks	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026