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A randomized, double-blind, parallel controlled clinical trial to evaluate the efficacy and safety of Duyiwei capsules in the treatment of knee osteoarthritis patients

A randomized, double-blind, parallel controlled clinical trial to evaluate the efficacy and safety of Duyiwei capsules in the treatment of knee osteoarthritis patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083198
Enrollment
Unknown
Registered
2024-04-18
Start date
2024-04-19
Completion date
Unknown
Last updated
2024-04-22

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

Conditions

knee osteoarthritis

Interventions

Experimental group:Celecoxib capsules+Duyiwei capsules
Control group:Celecoxib capsules+Duyiwei capsule simulator

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meets the Western medical diagnostic criteria for knee osteoarthritis in the "Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition)": (1) Recurrent knee joint pain within the past month; (2) X-ray film (standing or weight-bearing position) shows narrowing of joint space, subchondral bone sclerosis and/or cystic changes, and formation of osteophytes at the joint edge; (3) Age = 50 years old; (4) Morning stiffness time = 30 minutes; (5) There is bone fricative during activity (sensation); Note: Meeting the diagnostic criteria (1)+[any two of (2), (3), (4), and (5)] can diagnose knee osteoarthritis; 2. When included, the patient's Visual Analog Scale (VAS) score ranged from 3.0 to 7.4 points (including 3.0 and 7.4 points); 3. Age range from 40 to 75 years old (including 40 and 75 years old), regardless of gender; 4. The subject's body mass index (BMI) is between 18.5-34kg/m2; 5. Patients in grades I, II, and III who meet the Kellgren&Lawrence grading criteria for X-ray imaging examination (original image materials from tertiary hospitals within 2 months are acceptable); 6. Able to understand and comply with clinical protocol requirements, voluntarily participate in clinical trials, and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Individuals with allergic constitution, known to be allergic to the ingredients of the drug in this study; 2. Those who meet the Kellgren&Lawrence grading criteria for X-ray imaging examination and are classified as Grade IV; 3. Patients with immune disorders or other diseases that interfere with the efficacy indicators of this study: patients with other inflammatory diseases of the knee joint, such as rheumatoid arthritis, psoriatic arthritis, gout, tumors, villous nodular synovitis, joint trauma, purulent arthritis, and tuberculosis arthritis; Osteoarthritis caused by osteomyelitis, bone tumors, and bone tuberculosis; Patients with purulent, non-specific and other infectious knee osteoarthritis; 4. Individuals with unstable vital signs or severe organic diseases or mental disorders of the cardiovascular, lung, liver, kidney, brain, and hematopoietic systems; 5. Have received acupuncture and moxibustion, oral non steroidal anti-inflammatory drugs, hormone injection or sodium hyaluronate, topical plaster and other treatments in the last week; 6. Pregnant or lactating patients; 7. The researcher believes that any other situation that endangers the safety of the subjects, affects the researcher's evaluation, or results in poor adherence to the protocol.

Design outcomes

Primary

MeasureTime frame
Visual analogue pain score;Safety index;

Secondary

MeasureTime frame
WOMAC Scale Rating;Inflammatory marker C-reactive protein;

Countries

China

Contacts

Public ContactCao Yongping

Peking University First Hospital

freehorse66@163.com+86 139 1162 4418

Outcome results

None listed

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