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A randomized controlled intervention trial of the effect of aminoglycan chondroitin on osteoarthritis of the knee in menopausal women

A randomized controlled intervention trial of the effect of aminoglycan chondroitin on osteoarthritis of the knee in menopausal women

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090167
Enrollment
Unknown
Registered
2024-09-25
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Knee osteoatritis

Interventions

Intervention group:Chondroitin aminosugar and exercise
Intervention group:Placebo and exercise

Sponsors

Medical College, Wuhan University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 50 to 75 years; (2) Menopausal women (cessation of menstruation >12 months); (3) Unilateral knee joint lesion; (4) Patients with grade II to III active KOA according to the Kellgren-Lawrence imaging grading criteria for osteoarthritis; (5) Self-reported overall pain score of 40-80 mm on a 100 mm visual analog scale (VAS); (6) No intellectual, language and cognitive disabilities, and able to understand, cooperate and communicate with the intervention content; (7) Informed consent and voluntary participation in this study.

Exclusion criteria

Exclusion criteria: (1) Hypersensitivity to the subjects used in this trial (Glucosamine Hydrochloride, Chondroitin Sulfate, Calcium with placebo ingredients); (2) Combination of other types of arthritis, gout, joint injuries, vascular neuropathy in the affected limb; (3) Knee fractures, tumors; (4) Previous history of intra-articular injection therapy or surgical treatment and planned knee surgery in the next 6 months; (5) Patients who have used drugs affecting bone metabolism (excluding calcium and vitamin D supplements) within the last month or who have taken glucosamine, chondroitin sulfate related drugs or health products within the last month; (6) Those who have participated in other intervention programs within the last three months. (7) Serious liver and kidney disease, endocrine disease, autoimmune disease, serious cardiovascular disease, respiratory system and other diseases. (8) Relative contraindications to exercise: recent myocardial infarction, unstable angina, severe peripheral vascular disease and unstable angina.

Design outcomes

Primary

MeasureTime frame
Knee pain score;

Secondary

MeasureTime frame
Joint range of motion;Degree of stiffness, joint function;Patient self-evaluation;Timed up and go test;9-step stair-climb test;Balance;Lower limb functional level in patients with knee osteoarthritis;Quality of Life;Biomarkers of osteoarthritis;Inflammatory facto;Intestinal flora;Knee X-ray;MRI images of the knee joint;Bone density;

Countries

China

Contacts

Public ContactShuang Rong

Medical College, Wuhan University of Science and Technology

rongshuangwust@yeah.net+86 185 7172 7264

Outcome results

None listed

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