A study to evaluate the potential effectiveness of a dietary supplement for osteoarthritis

Completed

• Conditions: Healthy subjects with joint pain/discomfort, osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN15418623
• Lead Sponsor: nigen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-19
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Males and females, aged 35 to 75 years
2. BMI < 35 kg/m2
3. Knee pain for at least 15 of the 30 days prior to the start of the study
4. Symptoms of knee pain for at least 6 months
5. Grade I, II or III using Kellgren-Lawrence classification according to the screening X-ray
6. Able to walk
7. VAS-D score of = 6 at the randomization visit. Subjects will have stopped taking his/her usual medication at the screening visit (which will be 7 to 28 days prior to the randomization visit) and will not have taken rescue medication for the 2 days prior to the randomization visit
8. For subjects with Type 2 Diabetes, has HgbA1c of = 7.5%
9. Surgically sterile, post-menopausal or agrees to use an acceptable method of birth control
10. Agrees to not use any new vitamin and/or mineral supplement until after study completion
11. Agrees to not take any dietary or herbal supplements until after study completion. Seven-day washout period prior to visit 2 allowed
12. Agrees to not take any dietary or herbal supplements purported to decrease inflammation, body pain and/or improve joint health including glucosamine and MSM. Thirty-day washout period prior to visit 2 allowed
13. Willing and able to comply with the protocol including: attending 6 visits and discontinuing his/her usual OA medication and only taking acetaminophen in addition to the study product throughout the study period
14. Able to understand and sign the informed consent to participate in the study

Exclusion Criteria

1. Active heart disease or presence of a pacemaker
2. Cerebrovascular disease
3. Uncontrolled high blood pressure (if deemed clinically significant by the investigator)
4. Renal or hepatic impairment/disease
5. Type I diabetes
6. Bipolar disorder
7. Parkinson’s disease
8. Neuromuscular disease
9. Unstable thyroid disease
10. Immune disorder (such as HIV/AIDS)
11. Multiple sclerosis or any other autoimmune disorder
12. Any inflammatory arthritic condition
13. Acute septic arthritis
14. Fibromyalgia or other chronic pain syndromes (OA in locations other than knee allowed)
15. Gout, pseudogout and hyperuricemia
16. Paget’s disease
17. Active peptic ulcer disease and/or history of upper gastrointestinal bleeding
18. Any medical condition deemed exclusionary by the Principal Investigator (PI)
19. A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening
20. A history of psychiatric illness requiring hospitalization in the past 6 months
21. Ssignificant injury to the target joint within the past 12 months
22. History of joint replacement surgery at the index knee
23. History of arthroscopic surgery on the affected knee in the past 12 months or plans to have surgery in the next 6 months
24. Sulfa allergy or an allergy to sulphonamide
25. Allergy to shellfish and/or shrimp
26. Known allergy or sensitivity to any of the ingredients in the test product
27. Subjects with low blood pressure can only be included with PI approval due to potential worsening with Acacia catechu (Senegalia catechu).
28. Treated with oral corticosteroids within 4 weeks prior to screening
29. Intra-articular corticosteroids in the target joint within 3 months prior to screening
30. Hyaluronic acid injected in the target joint within 6 months prior to screening
31. Currently taking anticoagulants or antiplatelets
32. Unstable dose of medication (defined as fewer than 90 days at the same dose)
33. Currently taking any medication deemed exclusionary by PI
34. Evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being > 2 times the upper limit of normal or serum creatinine value > 1.5 times the upper limit of normal or other clinically significant abnormal clinical laboratory value per PI discretion
35. History of drug or alcohol abuse in the past 12 months
36. Plans to have surgery over the next 12 weeks
37. Pregnant, lactating, or planning to become pregnant during the study period
38. Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data
39. Participating or has participated in another research study within 30 days prior to visit 2

Study & Design

• Study Type: Interventional
• Study Design: Not specified