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Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee — TCM-OAK  

Osteoarthritis of the Knee Clinical Trial

Official title:
Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

Clinical Trial Summary

The purpose of this study is to determine if the traditional Chinese herbal compound (Huo-Luo-Xiao-Ling Dan, or HLXL) is effective in treating OA of the knee in addition to participants current OA of the knee treatment(s) and also to determine the best dosage of HLXL that is safe and well tolerated.

Clinical Trial Description

The specific aims of this project are:

1. To determine whether HLXL improves pain and/or function in patients with OA of the knee who continue to have symptoms despite receiving standard analgesic and/or anti-inflammatory treatment,

2. To identify an optimal dosage of HLXL, among two dosages, as determined by pain relief and/or functional improvement, in a dose-escalation, placebo-controlled double-blind randomized phase II clinical trial, in conjunction with indicia of safety and tolerability in patients with OA of the knee who are receiving standard analgesic and/or anti-inflammatory treatment,

3. To explore mechanisms of action of HLXL, correlating changes in biological markers of suppression of systemic inflammation with changes in clinical response ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00755326
Study type Interventional
Source University of Maryland, Baltimore
Contact
Status Completed
Phase Phase 2
Start date April 2007
Completion date July 2010
View Details
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