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

Last updated: January 28, 2022
Sponsor: Dongzhimen Hospital, Beijing
Overall Status: Active - Recruiting

Phase

N/A

Condition

Knee Injuries

Osteoarthritis

Treatment

N/A

Clinical Study ID

NCT05218122
2021DZMEC-139-03
  • Ages 20-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Inclusion criteria of liver and kidney deficiency syndrome and phlegm and blood stasissyndrome 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 liverand 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;
  1. 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

Exclusion Criteria:

  • Complications affecting joints, such as psoriasis, syphilitic neuropathy, brown yellowdisease, 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.

Study Design

Total Participants: 340
Study Start date:
December 24, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Dongzhimen Hospital

    Beijing, Beijing 100700
    China

    Active - Recruiting

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