Effect of a standardized hops extract on joint health
- Conditions
- Improvement of joint health in individuals with osteoarthritis of the kneeNot ApplicableGonarthrosis [arthrosis of knee]
- Registration Number
- ISRCTN10531169
- Lead Sponsor
- Pharmachem Laboratories, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1. Prospective subject is a male or female who is 40 to 75 years of age
2. Prospective subject has unilateral or bilateral OA of the knee (according to the ACR Criteria, Class I, II or III) without overt clinical signs of inflammation (i.e. joint swelling, effusion, erythema, palpable increased warmth)
3. Prospective subject has had pain in the target knee for at least six months prior to the study start
4. Prospective subject is able to walk unassisted (the use of a walking stick, crutch, and/or knee brace is permitted, at the discretion of the investigator)
5. Prospective subject has a score of greater or equal of 30, and less or equal of 80 at visit 1 on the first item of the WOMAC pain subscale (pain walking on a flat surface)
6. Prospective subject must be willing and able to carry out the provisions of the study, complete self-assessments and diaries, and read, sign and date an informed consent
1. Female prospective subject is pregnant, lactating (or lactating less than 6 weeks prior to the start of the study), less than three months postpartum, or wishes to become pregnant during the study. Female subject, capable of conceiving a child, is not willing to use, if necessary, an acceptable form of contraception, according to the principal investigator, for the duration of the study
2. Prospective subject has been diagnosed as having any inflammatory arthritis, or has any acute joint trauma at the knee with OA.
3. Prospective subject has signs of active target joint inflammation including redness, warmth, and/or a large, bulging effusion of the target knee joint with the loss of normal contour of the joint at the baseline examination (visit 1).
4. Prospective subject has secondary OA of the study target joint including septic arthritis, inflammatory joint disease, or other concurrent arthritic disease, rheumatoid arthritis, gout, Paget's disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, WIlson's disease, primary osteochrondromatosis, fibromyalgia, spinal disorders, and/or musculoskeletal disease.
5. Prospective subject has morning stiffness of greater than 30 minutes duration.
6. Prospective subject has had knee replacement surgery of the target joint.
7. Prospective subject has an active malignancy of any type or history of malignancy (e.g. breast cancer). (Subjects who have a history of basal cell carcinoma that has been treated are acceptable. Subjects with a history of other malignancies that have been surgically removed, and who have no evidence of recurrence for at least 5 years before study enrollment are also acceptable).
8. Prospective subject has clinically significant abnormal screening laboratory test values, at the discretion of the principal investigator.
9. Prospective subject has a history of cardiac event (e.g. myocardial infarction).
10. Prospective subject has coronary artery disease or suffers other clinical manifestations of atherosclerotic disease (e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease such as ischemic stroke).
11. Prospective subject has undergone coronary artery bypass graft (CABG) surgery.
12. Prospective subject has current asthma.
13. Prospective subject has an allergy to ibuprofen, aspirin, acetaminophen, or any NSAID medications.
14. Prospective subject has a chronic pain syndrome in the judgment of the principal investigator and has shown minimal response to any analgesic or anti0inflammatory medication.
15. Prospective subject is receiving therapy for chronic pain conditions for indications other than OA.
16. Prospective subject has class IV unilateral or bilateral OA of the knee, according to the ACR Criteria.
17. Prospective subject has had surgery (including arthroscopy) and/or significant injury of the target knee, within six months prior to study enrollment, or has an anticipated need for any surgical or other invasive procedure (e.g., arthroscopy, lavage, or general surgery) that will be performed during the course of the study, or within the 2 weeks after the completion of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perceived pain measured using WOMAC 5-item Symptom Assessment at hours 1, 2 and 4 post-dosing on day 1, daily on days 2 through 14 (for question 1, walking on a flat surface); daily on days 2 through 14 for questions 2-5 (going up and down stairs, at night while in bed, sitting or lying, standing upright).
- Secondary Outcome Measures
Name Time Method <br> 1. Time to perform a 20-meter walk on a flat surface measured at baseline (day 1) and day 15<br> 2. Consumption of rescue medication measured using self-recorded dairies daily for 14 days<br> 3. Adverse events measured using self-recorded dairies daily for 14 days<br> 4. Safety markers (Na, K, Ca, Cl, CO2, anion gap, glucose, blood urea nitrogen (BUN), creatinine, T Protein, albumin, T bilirubin, AST, ALT and ALK phosphatase) measured using fasting blood and urine samples at baseline (day 1) and day 15<br>