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A Clinical Trial of SUDOKU® Corn Germ Collagen Powder to Help Relieve Arthritis Pain Safety and Efficacy

A Clinical Trial of SUDOKU® Corn Germ Collagen Powder to Help Relieve Arthritis Pain Safety and Efficacy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095231
Enrollment
Unknown
Registered
2025-01-03
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Osteoarthritis

Interventions

Test group:SUDOKU Corn Germ Collagen Powder, 2 times a day (once in the morning and once in the evening), add an appropriate amount of warm water, stir well and drink, take it for 90 consecutive days

Sponsors

The People's Hospital of Chizhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age above 50 years old, gender is not limited; (2) Meet the diagnostic criteria for osteoarthritis of the knee in the Osteoarthritis Diagnostic and Treatment Guidelines (2018 edition); (3) Study side knee 100 mm visual analog scale (VAS) pain scores (movement status: walking) at baseline at screening were all 40 mm <= VAS < 80 mm, and the study side was defined as the side with the higher knee pain score at screening; (4) According to the WHO recommended diagnostic criteria for osteoporosis, bone mineral density (BMD) was detected by dual-energy X-ray absorptiometry (DXA), -2.5 < T-score < -1.0; (5) Non-habitual physical activity may be avoided from the start of the screening period and throughout the trial treatment period.

Exclusion criteria

Exclusion criteria: (1) Suffering from heart, liver, lung, kidney and other important organ diseases, blood diseases, tumor diseases, etc.; (2) Subjects with major mental illness, difficulty in controlling their behavior, and inability to cooperate; (3) Suffering from other types of bone and joint diseases and various diseases that may affect bone metabolism; (4) Those who have had open joint injury to the knee joint or have undergone other knee joint surgeries such as arthroscopy, arthroscopic dissection, and knee arthroplasty in the past 1 year; (5) Received intra-articular drug injection therapy (such as glucocorticoids, sodium hyaluronate, medical chitose, growth factors, platelet-rich plasma, etc.) in the past 3 months; (6) Use of Chinese and Western drugs for the treatment of osteoarthritis in the past 1 week, such as slow-acting drugs to relieve OA symptoms (diacerein, glucosamine, chondroitin sulfate, etc.), antineuralgia drugs (gabapentin, pregabalin, etc.), Chinese patent medicines (including artificial tiger bone powder, gold iron lock and other active ingredients) and other oral drugs and external preparations; (7) Those who have a history of taking calcium, vitamin D, anti-OP drugs and other drugs that affect bone metabolism in the past 2 weeks; (8) Patients with clinical diagnosis of gout or high uric acid; (9) Pregnant and lactating women and those who have a birth plan within 3 months; (10) Those who are judged by the investigator to be unsuitable to participate in this trial or are prone to loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Delayed Gadolinium-Enhanced MRI of Cartilage (dGEMRIC)?;

Secondary

MeasureTime frame
100 mm Visual Analogue Scale (VAS);Knee Osteoarthritis WOMAC Score;Health Assessment Questionnaire Index;Somatic function;Bone Metabolism Markers;

Countries

China

Contacts

Public ContactXie Guijie

The People's Hospital of Chizhou

xieguijie@163.com+86 153 3966 8111

Outcome results

None listed

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