Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee
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.


Options:
A: 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
B: Inclusion Criteria:

* Diagnosis of knee osteoarthritis according to the clinical and radiological criteria of the American College of Rheumatology (ACR), with minimum symptom severity/characteristics

Exclusion Criteria:

* Standard exclusions apply
C: Inclusion Criteria:

* Symptoms of osteoarthritis of the hip or knee for a minimum of six months
* History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen or another analgesic agent on a regular basis (\>= three days/week) for at least three months before the screening visit
* History of positive benefit with acetaminophen use for osteoarthritis pain
* History (ie, at any time in the past since diagnosis) of osteoarthritis pain of the hip or knee when not taking osteoarthritis analgesic medication
* Subjects must report a history of a pain level of moderate, moderately severe, or severe, a WOMAC pain score \>= 65 at baseline, and a 20% or greater increase in their pain score relative to their score at screening

Exclusion Criteria:

* History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
* Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria
* Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
* Secondary osteoarthritis of the study joint including, but not limited to, septic arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis
* History of acute inflammatory arthritis or pseudogout of the study joint.
D: Key Inclusion criteria:

• Osteoarthritis of the hand

Key Exclusion Criteria:

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs

Answer: A