Characteristics of LKDS and PBSS of KOA Based on the Enhancement of Inflammatory Response by TGF-β/Smad Pathway Inhibited

Dongzhimen Hospital, Beijing

Status: Enrolling

Conditions: Traditional Chinese Medicine; Knee Osteoarthritis; Syndrome

Treatments: Other: cross-sectional study without intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05218122

2021DZMEC-139-03

Details and patient eligibility

About

1. Through research and analysis, the levels of upstream and downstream factors related to TGF-β/Smad signaling pathway and inflammatory response factor related factors in serum, blood cells, articular fluid, urine, tongue covering and discarded tissues after surgery of patients with LKD syndrome and PBS syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
2. Through research and analysis, the index levels of multiple omics detection in serum, blood cells, joint fluid, urine, tongue coating and discarded tissues of patients with LKD syndrome and PBS syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
3. The severity of syndrome was quantified by syndrome score scale and the correlation between the above results and the syndrome score of patients with knee osteoarthritis with LKD syndrome and PBS syndrome was studied in combination with imaging characteristics.
4. To establish a "disease and syndrome cell model" and test relevant indicators to support the above research.
5. Through the analysis of the above research results, the possible mechanism is analyzed to provide an objective basis for the biological basis of the syndrome and relevant evidence for the clinical diagnosis and treatment of knee osteoarthritis with traditional Chinese medicine.

Full description

1. Through research and analysis, the levels of upstream and downstream factors related to TGF-β/Smad signaling pathway and inflammatory response factor related factors in serum, blood cells, articular fluid, urine, tongue covering and discarded tissues after surgery of patients with liver and kidney deficiency syndrome and phlegm and blood stasis syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
2. Through research and analysis, the index levels of multiple omics detection in serum, blood cells, joint fluid, urine, tongue coating and discarded tissues of patients with liver and kidney deficiency syndrome and phlegm and blood stasis syndrome of knee osteoarthritis were obtained, and the syndrome characteristics were further obtained.
3. The severity of syndrome was quantified by syndrome score scale and the correlation between the above results and the syndrome score of patients with knee osteoarthritis with liver and kidney deficiency syndrome and phlegm and blood stasis syndrome was studied in combination with imaging characteristics.
4. To establish a "disease and syndrome cell model" and test relevant indicators to support the above research.
5. Through the analysis of the above research results, the possible mechanism is analyzed to provide an objective basis for the biological basis of the syndrome and relevant evidence for the clinical diagnosis and treatment of knee osteoarthritis with traditional Chinese medicine.

Enrollment: 340 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Inclusion criteria of liver and kidney deficiency syndrome and phlegm and blood stasis syndrome in knee osteoarthritis

   • Age 20-80 years old, in line with the diagnostic criteria of Western medicine;
   • In accordance with the diagnostic criteria of TCM syndromes, it belongs to liver and kidney deficiency syndrome and phlegm and blood stasis syndrome;
   • Patients who are willing to participate in the survey and have good compliance;
   • Voluntary signing of informed consent;

2. Inclusion criteria of normal control group

   • Age 20-80 years old.
   • Patients who are willing to participate in the survey and have good compliance.
   • It does not meet the diagnostic criteria of knee osteoarthritis.
   • Voluntarily sign informed consent.

Exclusion criteria

• Complications affecting joints, such as psoriasis, syphilitic neuropathy, brown yellow disease, metabolic bone disease, etc;
• There were rheumatoid arthritis and ankylosing spondylitis;
• Late disabled and incapacitated;
• Pregnant or lactating women;
• Mentally ill.
• As long as one of the above 5 articles is met, it shall be excluded.

Trial design

340 participants in 3 patient groups

LKD syndrome

Description:

liver and kidney deficiency syndrome

Treatment:

Other: cross-sectional study without intervention

PBS syndrome

Description:

phlegm and blood stasis syndrome

Treatment:

Other: cross-sectional study without intervention

NC group

Description:

Normal Control group

Treatment:

Other: cross-sectional study without intervention