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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HLXL
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring OA

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland Center for Integrative Medicine Kernan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Huo-Luo-Xiao-Ling

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

‡Pain Normalized Score
‡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

Function Normalized Score
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).
Patient Global Assessment
§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?")

Full Information

First Posted
September 17, 2008
Last Updated
January 6, 2020
Sponsor
University of Maryland, Baltimore
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00755326
Brief Title
Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Acronym
TCM-OAK
Official Title
Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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 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, To explore mechanisms of action of HLXL, correlating changes in biological markers of suppression of systemic inflammation with changes in clinical response

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
OA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Huo-Luo-Xiao-Ling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Huo-Luo-Xiao-Ling (HLXL): Subjects in the placebo group received an equal number of placebo capsule.
Intervention Type
Drug
Intervention Name(s)
HLXL
Other Intervention Name(s)
Huo-Luo-Xiao-Ling (HLXL) Dan
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.
Primary Outcome Measure Information:
Title
‡Pain Normalized Score
Description
‡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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Function Normalized Score
Description
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).
Time Frame
8-Weeks
Title
Patient Global Assessment
Description
§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?")
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M. Berman, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Center for Integrative Medicine Kernan Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26099553
Citation
Lao L, Hochberg M, Lee DYW, Gilpin AMK, Fong HHS, Langenberg P, Chen K, Li EK, Tam LS, Berman B. Huo-Luo-Xiao-Ling (HLXL)-Dan, a Traditional Chinese Medicine, for patients with osteoarthritis of the knee: a multi-site, randomized, double-blind, placebo-controlled phase II clinical trial. Osteoarthritis Cartilage. 2015 Dec;23(12):2102-2108. doi: 10.1016/j.joca.2015.06.007. Epub 2015 Jun 20.
Results Reference
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Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

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