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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00755326
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Brian Berman, University of Maryland, Baltimore

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: HLXL Phase 2

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 two 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Study Start Date : April 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Huo-Luo-Xiao-Ling
Active herb Huo-Luo-Xiao-Ling (HLXL) The subjects in the HLXL group received the medium dose of HLXL (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.
Drug: HLXL
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.
Other Name: Huo-Luo-Xiao-Ling (HLXL) Dan

Placebo Comparator: Placebo
Placebo Huo-Luo-Xiao-Ling (HLXL): Subjects in the placebo group received an equal number of placebo capsule.
Drug: HLXL
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.
Other Name: Huo-Luo-Xiao-Ling (HLXL) Dan




Primary Outcome Measures :
  1. ‡Pain Normalized Score [ Time Frame: 8 weeks ]
    ‡Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis.


Secondary Outcome Measures :
  1. Function Normalized Score [ Time Frame: 8-Weeks ]
    Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis. Overall normalized score is on a scale of 0-30, and is the sum of the pain, stiffness and function normalized scores (each on a scale of 0-10).

  2. Patient Global Assessment [ Time Frame: 8 weeks ]
    §Patient Global Assessment is on a scale of 1-5, with 5 indicating excellent and 1 indicating poor (in response to the question "Considering all the ways that your osteoarthritis of the knee affects you, how are you feeling today?")



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755326


Locations
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United States, Maryland
University of Maryland Center for Integrative Medicine Kernan Hospital
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
University of Maryland, Baltimore
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Brian M. Berman, MD University of Maryland, Baltimore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Berman, Director, Center for Integrative Medicine, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT00755326    
Other Study ID Numbers: HP-00040954
U19AT003266-01 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2008    Key Record Dates
Results First Posted: January 18, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Brian Berman, University of Maryland, Baltimore:
OA
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases