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External governance within the preparation and staging the clinical curative effect of treatment of knee osteoarthritis and related research

external governance within the preparation and staging the clinical curative effect of treatment of knee osteoarthritis and related research

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16008992
Enrollment
Unknown
Registered
2016-08-08
Start date
2016-05-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

knee osteoarthritis,OA

Interventions

Conventional western medicine treatment group:Sodium hyaluronate injection
Traditional Chinese medicine treatment group: Overcoating and Medical Treatment
Chinese and western medicine treatment group:Overcoating and Medical Treatment

Sponsors

Gansu hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. in accordance with the western medicine diagnostic criteria and the standard of diagnosis of disease and curative effect of traditional Chinese medicine "wind cold dampness bi, rheumatic fever bi, blood stasis resistance syndrome, liver and kidney deficiency type closed in patients with knee osteoarthritis; 2. Aged 18-75 years, male and female; 3. the research of knee osteoarthritis X-ray evidence for level 1, 2, 3 (Kellgren and Lawrence radiological grading). 45 degree shaft break a class 1, 2, 3; Color ultrasonic class for 1, 2, 3; 4. body mass index (BMI) 35 kg/m2 or less; 5. side of the knee on the ground walk, VAS score between 21-90 - mm; 6. patients with treatment requirements and can finish as planned, and be able to cooperate and follow-up clinical observer; 7. subjects in fully understand the nature of this study, the nature of the disease, a drug of features, relevant treatment and to participate in this study may need to bear the risk, can understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. knee other painful inflammatory disease: rheumatism and rheumatoid arthritis, psoriatic arthritis, gout, hemophilia sex arthritis, infectious arthritis, etc.; 2. outside of the knee osteoarthritis knee painful injuries, such as joints of tumor villi nodular synovitis, joint trauma (meniscus tear, ligament injury, bone contusion and cartilage fracture), etc.; 3. inflation), or skin temperature increased significantly or bone mineral density 10 degree, genu valgum > 20 degree deformity and joint gap; 8. cancer patients in recent five years), alzheimer's disease; 9. of the knee osteoarthritis Kellgren and Lawrence radiological grading evidence of 0, 4. 45 degree shaft break a class 4; High frequency color ultrasound class 0 to 4; 10. within 1 month before the test using glucocorticoid hormone drugs or participated in clinical trials of other drugs, participate in the clinical trials have analgesic drugs to be stopped at least a week before can be selected; 11. within 3 months before the experiment research knee joint cavity treatment, including joint, joint cavity flushing, arthroscopic surgery; 12. this test related pharmaceutical ingredients known allergies; 13. other researchers judgment is not suitable for selected participants.

Design outcomes

Primary

MeasureTime frame
general data;WOMAC pain score;WOMAC rigid score;FDIP of WOMAC;life quality score of SF-12;

Secondary

MeasureTime frame
Color ultrasonic evaluation;

Countries

China

Contacts

Public ContactShenhua Li

Gansu hospital of TCM

lishenghua0619@126.com+86 13993122066

Outcome results

None listed

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