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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Berman, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT00755326
First received: September 17, 2008
Last updated: February 19, 2013
Last verified: February 2013

September 17, 2008
February 19, 2013
April 2007
April 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00755326 on ClinicalTrials.gov Archive Site
Secondary: Evaluate adherence, use of other pain and/or anti-inflammatory drugs, change in biomarkers of inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of the Knee
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
Other Name: Huo-Luo-Xiao-Ling (HLXL) Dan
  • Active Comparator: HLXL
    Active herb
    Intervention: Drug: HLXL
  • Placebo Comparator: Placebo
    Placebo HLXL
    Intervention: Drug: HLXL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00755326
HP-00040954, 1 P01 AT002605-01A1
Yes
Brian Berman, MD, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Brian M. Berman, MD University of Maryland, Baltimore County
University of Maryland
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP