Please select the eligibility criteria that correspond to the clinical trial below.
Title: Clinical Evaluation of Condrosulf 800 mg in the Treatment of Symptomatic OA of the Hand: a 6-month, Double-blind, Placebo Controlled Study
Brief Summary: The goal of the present study is to investigate the effectiveness of Condrosulf® 800 mg tablets vs. placebo once a day for 6 months in the symptomatic treatment of finger joint osteoarthritis.

Primary endpoints of the study are the evaluation of global spontaneous pain (Huskisson's Visual Analogue Scale: VAS) and the score of Dreiser's algo-functional index (FIHOA) during the treatment with the tested product, Condrosulf®, versus placebo.


Options:
A: Inclusion Criteria:

- General entrance criteria included being a female with physician diagnosed OA between the ages of 18-70 years with a body mass index (BMI) \> 27 kg/m2 and no recent participation in a diet or exercise program.

Exclusion Criteria:

- Subjects were not allowed to participate in this study if they: 1.) were pregnant, became pregnant, or had a desire for pregnancy; 2.) had any metabolic disorder including known electrolyte abnormalities, heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; 3.) had a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease; were taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications; 4.) had taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (e.g., DHEA), or weight loss supplements (e.g., thermogenics) within three months prior to the start of the study; 5.) were ingesting any anti-inflammatory products two weeks before the start of the study or additional products during the study; 6.) reported any unusual adverse events associated with this study in which the supervising physician recommended removal from the study; 7.) had significant injury or surgery to the lower extremity or spine within the last six months; 8.) did not indicate a minimal amount of perceived pain and physical function limitation on inventories used in the study; 9.) had severe arthritis that required surgery and greatly limited functionality (inability to perform lunge); or, 10.) had arthritis that required the current use of physiotherapy modalities.
B: 40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.
C: Inclusion Criteria:

* Patients of either sex
* Aged 40 and over
* Outpatients
* Patients fulfilling the American Congress of Rheumatology (ACR) criteria for the reporting of hand OA
* Patients showing X-ray features of hand OA on at least two joints (2 IP and/or 1 IP and 1 TMC) of the dominant hand on standard plain radiographs (\< 6 month).
* Suffering from regular spontaneous pain on the dominant hand (VAS \> or = 40 mm at inclusion time).
* Showing a FIHOA score \> or = 6.
* Having had at least two painful flares in a finger joint during the previous 12 month.
* Patients who have signed the written informed consent for their participation in the study
* Patients able to understand and follow the protocol.
* Patients with a satisfying health and nutritional status.
* Female subjects of childbearing potential using, within three months prior to the inclusion in the study, a reliable form of contraception during the course of the study (oral contraceptive pill, intrauterine device or condoms) or female of non childbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation).
* Female subjects of childbearing potential with a negative urinary pregnancy test before the inclusion in the study.

Exclusion Criteria:

* Inflammatory joint disease of other origin
* Septic arthritis
* Chronic inflammatory joint disease
* Previous articular fracture of the concerned articulations
* Use of analgesic therapy for other indications
* Receiving oral corticosteroids
* Mono-articular posttraumatic OA of the finger
* Planning surgery of the hands in the following 6 months
* Patients suffering or having suffered from secondary osteoarthritis after one of the following diseases:

  * Infectious arthritis - Acromegaly
  * Ochronosis - Hemachromatosis
  * Gout - Wilson's disease
  * Chondrocalcinosis - Paget's disease
  * Osteochondrosis - Mutation of collagen
  * Genetic problems (for ex. hypermobility) - Previous joint fracture
  * Arthropathies of different aetiologies - Algodystrophy (M. Sudeck)
* Congenital abnormalities
* Recurrent pseudogout
* Major dysplasias
* Intra-articular injection in a hand joint from less than 3 months
* Basic treatment of arthritis with symptom-modifying agents (chondroitin sulfate, glucosamine sulfate, diacerhein, hyaluronic acid) in the last 3 months
* Articular lavage in the last 3 months
* Treatment with corticoids, by any administration route during the last month
* Patient suffering from frequent asthma crises
* Physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) on the hands foreseeable in the next year
* Serious organic diseases: heart failure, renal or hepatic insufficiency, blood dyscrasia, serious infection
* Participation in other clinical trials in the two months preceding the study
* Known or ascertained hypersensitivity to the active ingredient of the tested drug.
* Patients refusing to sign the written informed consent form
* Patients who do not co-operate, not respecting the protocol requirements
* Pregnant or lactating women
D: Inclusion Criteria:

* Primary knee OA according to ACR criteria;
* OA of radiological stages 1 to 3 according to Kellgren-Lawrence;
* VAS of pain ≥30;
* PASI ≥ 5.

Exclusion Criteria:

* Known allergy to chondroitin sulphate;
* Other bone and articular diseases such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis, Wilson's disease;
* Patients with skin conditions that could interfere in the clinical trial evaluation

Answer: C