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A human feeding trial of glucosamine chondroitin tablets, Ca-Zn vitamin D vitamin K tablets and their combined use to improve symptoms in people with knee osteoarthritis and osteopenia

A human feeding trial of glucosamine chondroitin tablets, Ca-Zn vitamin D vitamin K tablets and their combined use to improve symptoms in people with knee osteoarthritis and osteopenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120436
Enrollment
Unknown
Registered
2026-03-13
Start date
2026-03-13
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

knee osteoarthritis and osteopenia

Interventions

Feeding Group 2:Glucosamine chondroitin tablets and Ca-Zn vitamin D vitamin K Simulant
Feeding Group 3:Glucosamine chondroitin Simulant and Ca-Zn vitamin D vitamin K tablets
Feeding Group 1:Glucosamine chondroitin tablets and Ca-Zn vitamin D vitamin K tablets

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Individuals aged 40 to 80, regardless of gender; 2. Meeting the diagnostic criteria of knee osteoarthritis in Western medicine, with Kellgren-Lawrence classification at grade I-II, and the bone density test result at the lumbar spine being -2.5 SD < T < -1.0 SD; 3. Knee joint pain during walking with a F-VAS score of 3 <= F-VAS score <= 6; 4. Participants voluntarily signed the informed consent form to participate in the trial.

Exclusion criteria

Exclusion criteria: 1. Patients with osteoporosis, history of brittle fractures, and history of fractures in the lumbar spine or knee joints; 2. Patients with diseases affecting bone metabolism, including hypogonadism, diabetes, various endocrine system diseases such as hyperthyroidism, rheumatic immune diseases, gastrointestinal diseases, hematological diseases, neuromuscular diseases, heart failure (NYHA classification of grade III-IV), etc.; 3. Patients with implanted devices in the lumbar spine or hip, and osteomalacia; 4. Patients requiring medications that affect bone metabolism, including glucocorticoids, proton pump inhibitors, antiepileptic drugs, aromatase inhibitors, gonadotropin-releasing hormone analogues, antiviral drugs, thiazolidinedione drugs, and excessive thyroid hormones, etc.; 5. Patients with recurrent knee joint swelling and effusion, progressive pain, significant joint dysfunction, and joint deformity, and poor response to non-surgical treatment; 6. Patients with hypercalcemia, hypercalciuria, and calcium-containing kidney stones; 7. Patients who need to take digitalis glycosides, tetracyclines and quinolone antibacterial drugs, aluminum-containing antacids or aluminum-containing antacids during the study period; 8. Patients known to be allergic to the components of the trial food products; 9. Patients whose AST or ALT or ALP levels were greater than 2 times the upper limit of normal (ULN) during the screening period, or whose serum creatinine was greater than 1.5 times the ULN; 10. Pregnant and lactating women, and patients who refuse to take contraceptive measures throughout the study; 11. Those who have participated in other clinical trials in the past 3 months or are currently participating in other clinical trials; 12. Those suspected to have a confirmed history of drug abuse; 13. Patients considered not suitable for inclusion in this study by the researchers.

Design outcomes

Primary

MeasureTime frame
the F-VAS score;

Secondary

MeasureTime frame
WOMAC daily adctivity score;Usage of emergency medications;Incidence of falls;WOMAC pain score;WOMAC stiffness score;bone density;Clinical symptom score;physical examination;Serum Chemistry;WOMAC total score;bone metabolism indicators;vital signs;Hematology;the F-VAS score;SF-36 scale;

Countries

China

Contacts

Public ContactWeiyi Yang

Guangdong Provincial Hospital of Chinese Medicine

czyangwy@163.com+86 20 81887233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026