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

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Control Patch	Placebo Patch	Placebo Patch
Experimental Patch	Herbal Patch	Herbal Patch

Primary Outcome Measures

Name	Time	Method
Pain Score	Day 7	The WOMAC (Western Ontario and McMaster Universities Index of Osteoarthritis) Pain Subscale Score

Secondary Outcome Measures

Name	Time	Method
Subject Assessment	Day 14	Subject Global Assessment of Response to Treatment: WOMAC Physical Function Subscale and Subject Global Assessment of OA Condition
Investigator Assessment	Day 14	Investigator Global TCM Assessment of OA Condition: WOMAC Stiffness Subscale, Total WOMAC Index

Locations (12): Luoyang Orthopedic & Traumatologic Hospital of Henan Province
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Luoyang, Hubei, China
Wu Xi Chinese Medical Hospital
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Wuxi, Jiangsu, China
Jiang Su Province Hospital of TCM Hospital
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Nanjing, Jiangsu, China
Union Hospital affiliated to Tong Ji Medical College
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Wu Han, Hubei, China
Xiangya Hospital Central-South University
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Changsha City, Hunan, China
Shanghai Rui Jin Hospital
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Shanghai, Shanghai, China
Su Zhou Chinese Medicine Hospital
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Suzhou, Jiangsu, China
Shan Xi Provincial People's Hospital
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Xi'an, Shanxi, China
Affiliated Hospital of Shan Xi TCM College
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Xianyang, Shaanxi, China
1st Affiliated Hospital of Tian Jin TCM College
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TianJin, Tianjin, China
Shanghai Chinese Medical Hospital
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Shanghai, Shanghai, China
Affiliated Hospital of Chengdu University of TCM
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Chengdu, Sichuan, China