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
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: HLXL
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 120
Study Start Date: April 2007
Study Completion Date: July 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HLXL
Active herb
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
Placebo Comparator: Placebo
Placebo HLXL
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

Detailed 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 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
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755326

Locations
United States, Maryland
University of Maryland Center for Integrative Medicine Kernan Hospital
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Brian M. Berman, MD University of Maryland, Baltimore County
  More Information

No publications provided

Responsible Party: Brian Berman, MD, Director, Center for Integrative Medicine, University of Maryland
ClinicalTrials.gov Identifier: NCT00755326     History of Changes
Other Study ID Numbers: HP-00040954, 1 P01 AT002605-01A1
Study First Received: September 17, 2008
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
OA

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014