Official Title: “Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2010

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 three 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

Intervention(s) in this Clinical Trial

• Drug: HLXL
  • Three daily dosages will be investigated. The lowest dosage condition will be 6 capsules (2,400 mg) daily, followed by an escalation to the 10 capsule condition (4,000 mg), and then to the 14 capsule (5,600 mg) condition. Participants will be treated for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: HLXL
  • Active herb
• Placebo Comparator: Placebo
  • Placebo HLXL

Primary Measures

• Primary: To determine whether HLXL is efficacious in treating osteoarthritis of the knee, and to identify the optimal dosage of HLXL that is safe and well tolerated as adjunct treatment to standard care for osteoarthritis (OA) of the knee
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Secondary Measures

• Secondary: Evaluate adherence, use of other pain and/or anti-inflammatory drugs, change in biomarkers of inflammation
  • Time Frame: 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Age 40 years or above
• Diagnosis of OA of the knee of at least 6 months duration fulfilling American College of Rheumatology criteria
• Pain in at least one knee of at least moderate severity (Likert scale [none, mild, moderate, severe, extreme] or VAS pain score of at least 40 [0-100]) on most (at least 15) days of the previous 1 month
• Taking analgesic or nonsteroidal anti-inflammatory agents for control of pain
• Documented radiographic changes of osteoarthritis of the knee (Kellgren-Lawrence grade greater than or equal to 2 at the time of screening)
• Stable on arthritis medications for previous 1 month
• Willingness and ability, with help of a caregiver if necessary, to comply with treatment and follow-up procedures
• Use of effective contraception if woman of childbearing potential
• Signed consent statement

Exclusion Criteria:

• Intra-articular (IA) corticosteroid injection of either knee within a 3 month interval immediately prior to baseline screening
• IA hyaluronates in either knee within the past 6 months
• Tidal lavage or arthroscopy of either knee within the past 12 months
• Medical condition, in the judgment of the examiner and/or study investigators, that may preclude safe participation in protocol or prevents completion of the study, such as: uncontrolled angina and/or congestive heart failure, severe chronic obstructive pulmonary disease, active treatment for cancer, major psychiatric disease, other severe systemic disease, or significant abnormalities on screening physical examination and laboratory tests that reveal clinically important abnormalities of hematological, cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or other systems
• Use of any constituent herb in HLXL within the past 3 months
• Current use of Chinese herbs for arthritis
• Use of oral prednisone in the past 30 days
• Current use of anti-coagulants (coumadin, heparin, aspirin >325 mg per day).
• Use of any investigational drug within the past 30 days
• Inflammatory arthritis (e.g., rheumatoid or psoriatic arthritis)
• Currently participating in another intervention research study
• Unwilling to be randomized
• Plan to move residence away from the immediate area within the next 2 months
• Drug or alcohol abuse sufficient to hinder compliance with treatment or follow-up procedures
• Pregnant or lactating
• Exclusive use of a wheel chair
• Surgery in either knee in past one year

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Maryland

Overall Clinical Trial Officials and Contacts

Brian M. Berman, MD Principal Investigator University of Maryland  

Overall Contact: mary k bahr-robertson, BA 410-448-6607 mbahr@compmed.umm.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00755326

Study ID Number: H-27497

ClinicalTrials.gov Identifier: NCT00755326

Health Authority: United States: Food and Drug Administration