Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: HLXL
Intervention description: Two daily dosages will be investigated. Huo-Luo-Xiao-Ling (HLXL) dose (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/ day) for the subsequent 6 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: OA

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.
    

Eligibility criteria:

        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