A Controlled Study of an Herbal Topical Patch in Treating Osteoarthritis (OA) of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-04-30

Brief Summary

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An evaluation of the safety and efficacy of an herbal patch in treating osteoarthritis pain of the right or left knee.

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Detailed Description

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This is a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of herbal patch in subjects with OA knee pain. The overall objective of this study is to evaluate the efficacy and safety of the patch in relieving OA knee pain.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Patch

Herbal Patch

Group Type EXPERIMENTAL

Herbal Patch

Intervention Type OTHER

1 herbal patch applied for approximately 8 hours per day for 14 days

Control Patch

Placebo Patch

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type OTHER

Control patch with no herbal ingredients

Interventions

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Herbal Patch

1 herbal patch applied for approximately 8 hours per day for 14 days

Intervention Type OTHER

Placebo Patch

Control patch with no herbal ingredients

Intervention Type OTHER

Other Intervention Names

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Traditional Chinese Medicine Topical Analgesic Patch Not a marketed product

Eligibility Criteria

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Inclusion Criteria

* Male or female between 40 and 70 years of age
* Medically cleared to participate by a site affiliated physician following a physical
* History of, or current diagnosis of, OA of the knee
* Evidence of idiopathic OA of at least one knee
* Subject Assessment of OA pain in target knee 40 - 75 mm (on the 100 mm VAS inclusive) in the index knee, on the WOMAC Pain composite subscale at Visit 1
* Subject Assessment of OA pain in non-index knee (if applicable) is ≤ 20mm
* Subject Global Assessment of OA Condition (5 pt categorical scale, 1 = very good to 5 = very poor) of grade 3-5 (i.e. fair, poor or very poor)
* Evidence of idiopathic OA of at least one knee as defined by the American College of Rheumatology Classification (ACR) of OA of the Knee

Exclusion Criteria

* Grade 1 or Grade 4 severity of the index knee based on the Kellgren and Lawrence radiographic criteria
* Pain greater than 20 mm on the VAS in the non-index knee (either at rest or with movement)
* Prior injection or arthroscopy of study knee within 3 months
* Crystalline-induced synovitis (e.g. gout, pseudo gout, nonsteroid arthritis, hydroxyapatite deposit), acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, fibromyalgia, systemic lupus, erythematosus collagen vascular disease or other types of inflammatory arthritis in the index knee
* Pain in either knee is of neurological origin
* An injury or surgery to the same body region within the prior 6 months or a lifetime history of 3 or more injuries/surgeries to the injured body region
* Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
* Other criteria that - in the opinion of the investigator - may jeopardize the safety of the subject or the study results.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No