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Study on the optimized regimen of Wenyang Yisui method combined with platelet-rich plasma in the treatment of early and mid-stage knee osteoarthriti

Study on the optimized regimen of Wenyang Yisui method combined with platelet-rich plasma in the treatment of early and mid-stage knee osteoarthritis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060911
Enrollment
Unknown
Registered
2022-06-14
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

Knee osteoarthritis

Interventions

Group 1:Wenyang Yisui Prescription
Group 2:Intra-articular injection of PRP
Group 3:Wenyang Yisui Prescription combined with intra-articular injection of PRP

Sponsors

Wangjing Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Western medicine diagnostic criteria: According to the 2018 edition of the Chinese Medical Association "Osteoarthritis Diagnosis and Treatment Guidelines" diagnostic criteria for knee osteoarthritis. (1) Repeated knee pain in the past month; (2) X-ray films (standing or weight-bearing) show narrowing of the joint space, subchondral bone sclerosis (or cystic degeneration), and the formation of osteophytes at the joint edge; (3) Age is greater than or equal to 50 years old; (4) Morning stiffness is less than or equal to 30 minutes; (5) Bone fricative (or friction) during activity; The diagnosis can be made if the diagnostic criteria 1+ (any 2 out of 2, 3, 4, and 5). 2. Kellgren-Lawrance X-ray grading (5 grades): Level 0: normal; Grade I: Suspected joint space narrowing and possible labial hyperplasia; Grade II: Certain osteophytes and possible joint space narrowing; Grade III: Moderate multiple osteophytes, sure joint space narrowing, sclerosis and possible bone end deformation; Grade IV: Large osteophytes, marked joint space narrowing, severe sclerosis and certain bone end deformities. 3. TCM diagnostic criteria: refer to "Guidelines for Clinical Research on New Chinese Medicines" edited by Zheng Xiaoyu. Main symptoms: dull pain in the knee or soreness and weakness of the waist and knee, cold body and cold limbs; Secondary symptoms: unfavorable activity, far-fetched operation, morning stiffness and chills, red tongue, thin or thin white fur, slippery or stringy pulse. 4. Inclusion criteria: (1) Meet the above diagnostic criteria of western medicine or traditional Chinese medicine; (2) Meet the requirements of the researched diagnosis and treatment technical indications; (3) Age is 50-65 years old; (4) Kellgren-Lawrance X-ray classification 0, I, and II; (5) Sign the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patients who do not meet the above diagnostic criteria and inclusion criteria. 2. Patients who has received other related treatments, which may affect the observation of the effect indicators of this study. 3. Patients with life-threatening primary diseases such as cardiovascular and cerebrovascular, liver and kidney, and mental illness. 4. Diseases excluded from the study: (1)Rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, etc.; (2)Infectious arthritis: joint tuberculosis, septic arthritis, etc.; (3)Reactive arthritis: allergic arthritis, thrombocytopenic purpura arthritis, etc.; (4)Metabolic joint diseases: Kashin-Beck disease, gout, etc.; (5)Intra-articular tumor; (6)Other specific joint diseases.

Design outcomes

Primary

MeasureTime frame
WOMAC Osteoarthritis Index score;Lequesne Index score;TCM clinical symptom score;IL-1ß;TGF-ß;MMP-1;MMP-3;

Countries

China

Contacts

Public ContactZhang Hongmei

Wangjing Hospital of China Academy of Chinese Medical Sciences

didongxue1532@163.com13910626823

Outcome results

None listed

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