Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee - Full Text View

Sponsored by:	University of Maryland
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00755326

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 II

MedlinePlus related topics: Marijuana Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

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 ]

Estimated Enrollment:	180
Study Start Date:	April 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
HLXL: Active Comparator 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
Placebo: Placebo Comparator 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

Detailed Description:

The specific aims of this project are:

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,
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,
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

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

Contacts

Contact: mary k bahr-robertson, BA	410-448-6607	mbahr@compmed.umm.edu
Contact: deborah taber, BS	410-448-6809	dtaber@compmed.umm.edu

Locations

United States, Maryland
University of Maryland Center for Integrative Medicine Kernan Hospital	Recruiting
Baltimore, Maryland, United States, 21207
Principal Investigator: brian m berman, MD

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Brian M. Berman, MD

University of Maryland

More Information

Responsible Party:	University of Maryland ( Brian M. Berman )
Study ID Numbers:	H-27497, 1 P01 AT002605-01A1
Study First Received:	September 17, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00755326
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Maryland:

OA

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Rheumatic Diseases
Marijuana Abuse

ClinicalTrials.gov processed this record on January 13, 2009