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

NCT ID: NCT05218122

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-24
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis; Syndrome; Traditional Chinese Medicine

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

LKD syndrome

liver and kidney deficiency syndrome

cross-sectional study without intervention

Intervention Type: OTHER

cross-sectional study without intervention

PBS syndrome

phlegm and blood stasis syndrome

cross-sectional study without intervention

Intervention Type: OTHER

cross-sectional study without intervention

NC group

Normal Control group

cross-sectional study without intervention

Intervention Type: OTHER

cross-sectional study without intervention

Interventions

cross-sectional study without intervention

cross-sectional study without intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Chao Ye

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dongzhimen Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Rui Zheng

Role: primary

yechao@bucm.edu.cn

+8601084012709

Other Identifiers

2021DZMEC-139-03

Identifier Type: -

Identifier Source: org_study_id