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Clinical trial to evaluate the effect of a glucosamine containing functional food on joint health in healthy Chinese people with mild-to-moderate osteoarthritis of the knee

Clinical trial to evaluate the effect of a glucosamine containing functional food on joint health in healthy Chinese people with mild-to-moderate osteoarthritis of the knee

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001283
Enrollment
Unknown
Registered
2011-03-31
Start date
2010-12-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Interventions

Group B:Placebo, 4 tabs/day, 2 tabs per time and 2 times pre day, None active ingredient
Group A:Nutrilite Joint Health Product, 4 tabs/day, 2 tabs per time and 2 times pre day, Containing Glucosamien sulfate/turmeric/rhizoma drynariae.

Sponsors

Chinese Center for Desease Control and Prevention
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Men and women 18-75 years of age, with preferable 45-75 years of age; 2. Individual sould be judged to be in good general health on the basis of medical history and physical exam; 3. Clinical diagnosis of mild-to moderate osteoarthritis of the knee. 4. Individual must be willing to make no significant changes to their regular diet and exercise regime throughout the duration of the study; 5. Individual understands the procedures and agrees to participate in the study; 6. Individual is able and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Participation in another clinical trial within 30 days of enrollment into the study; 2. Known hypersensitivity to study product or any ingredient in study product; 3. Presence of cardiovascular disease and hypertension with inconsistent medication regimen, unstable conditions, and without proper physician's supervision identified from the findings of the interview; 4. Presence of cancer, diabetes mellitus, rheumatic arthritis, severe secondary osteoarthritis (i.e. posttraumatic), severe osteoarthritis (primary), malformation in bone (i.e. scoliosis) or any other chronic health condition identified from the findings of the interview; 5. Maintaining to use the dietary supplements which are benefit to joint; 6. A change in using of dietary supplements within one week of Day 1. Supplements include any vitamins, minerals, and herbal products, including herbal drinks; 7. A change in drug medication history within 4 weeks prior to screening, or unwilling to maintain current drug therapy throughout the course of the study; 8. A change in hormone therapy, including oral contraceptives, within 4 weeks prior to screening (week -4), or unwilling to maintain current hormone therapy/oral contraceptive use throughout the course of the study; 9. Pregnant or lactating women, or women of child-bearing potential unwilling to use a medically approved form of birth control; 10. History or current abuse of drugs or alcohol, or intake > 2 alcoholic beverages per day; 11. Any condition that the Principal Investigator believes may put the subject at undue risk.

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire;

Secondary

MeasureTime frame
Visual analog scale (VAS) questionnaire;

Countries

China

Contacts

Public ContactKeji Li
li.keji@163.com+86 10 82802889

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026