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

To Explore the Characteristics of LKD Syndrome and PBS Syndrome of Knee Osteoarthritis Which Based on the Enhancement of Inflammatory Response Caused by the Inhibition of TGF-β/Smad Signal Pathway

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05218122
Enrollment
340
Registered
2022-02-01
Start date
2021-12-24
Completion date
2024-12-31
Last updated
2022-02-01

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

Conditions

Knee Osteoarthritis, Syndrome, Traditional Chinese Medicine

Keywords

TGF-β/Smad signaling pathway, disease and syndrome cell model, knee osteoarthritis, syndrome, traditional Chinese medicine

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.

Interventions

cross-sectional study without intervention

Sponsors

Dongzhimen Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
the differences of metabonomics3 yearsThe differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in LKD group, PBS group and NC group.
the differences of metabonomics in the cell models of disease-TCM syndrome3 yearsThe differences of metabonomics in the cell models of disease-TCM syndrome will be detected by metabonomics.
the differences of proteomics in the cell models of disease-TCM syndrome3 yearsThe differences of proteomics in the cell models of disease-TCM syndrome will be detected by proteomics.
the differences of proteomics3 yearsThe differences of proteomics in blood, urine and tongue coating will be detected by proteomics in LKD group, PBS group and NC group.
the differences of transcriptomics3 yearsThe differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in LKD group, PBS group and NC group.
the differences of transcriptomics in the cell models of disease-TCM syndrome3 yearsThe differences of transcriptomics in the cell models of disease-TCM syndrome will be detected by transcriptomics.
the related indexes of TGF- β/ Smad signaling pathway and inflammatory response3 yearsHistological and pathological examination is used to detect the related indexes of TGF- β/ Smad signaling pathway and inflammatory response.
The clinical TCM scores of LKD3 yearsThe minimum value is 0 and maximum value is 38, and higher scores mean a worse outcome.
The clinical TCM scores of PBS3 yearsThe minimum value is 0 and maximum value is 41, and higher scores mean a worse outcome.
The grading scores of Kellgren Lawrence (K-L)3 yearsThe minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome.
The grading scores of Yulish3 yearsThe minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome.
Clinical data3 yearsCollect clinical data and formulate a unified questionnaire, including the name, age, gender, outpatient / inpatient number, past history, current medical history, imaging images and other relevant data of patients with knee osteoarthritis.
Concentration of BLC (CXCL13)3 yearsConcentration of BLC (CXCL13) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of BLC (CXCL13) in the cell models of disease-TCM syndrome3 yearsConcentration of BLC (CXCL13) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Eotaxin-1 (CCL11)3 yearsConcentration of Eotaxin-1 (CCL11) will be detected by ELISA will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Eotaxin-1 (CCL11) in the cell models of disease-TCM syndrome3 yearsConcentration of Eotaxin-1 (CCL11) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Eotaxin-2 (MPIF-2/CCL24)3 yearsConcentration of Eotaxin-2 (MPIF-2/CCL24) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Eotaxin-2 (MPIF-2/CCL24) in the cell models of disease-TCM syndrome3 yearsConcentration of Eotaxin-2 (MPIF-2/CCL24) will be detected by ELISA in the cell models of disease-TCM.
Concentration of GCSF3 yearsConcentration of GCSF will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of GCSF in the cell models of disease-TCM syndrome3 yearsConcentration of GCSF will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of GM-CSF3 yearsConcentration of GM-CSF will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of GM-CSF in the cell models of disease-TCM syndrome3 yearsConcentration of GM-CSF will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of I-309 (TCA-3/CCL1)3 yearsConcentration of I-309 (TCA-3/CCL1) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of I-309 (TCA-3/CCL1) in the cell models of disease-TCM syndrome3 yearsConcentration of I-309 (TCA-3/CCL1) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of ICAM-1(CD54)3 yearsConcentration of ICAM-1(CD54) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of ICAM-1(CD54) in the cell models of disease-TCM syndrome3 yearsConcentration of ICAM-1(CD54) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IFN-gamma3 yearsConcentration of IFN-gamma will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IFN-gamma in the cell models of disease-TCM syndrome3 yearsConcentration of IFN-gamma will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-1 alpha (IL-1 F1)3 yearsConcentration of IL-1 alpha (IL-1 F1) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 alpha (IL-1 F1) in the cell models of disease-TCM syndrome3 yearsConcentration of IL-1 alpha (IL-1 F1) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-1 beta (IL-1 F2)3 yearsConcentration of IL-1 beta (IL-1 F2) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 beta (IL-1 F2) in the cell models of disease-TCM syndrome3 yearsConcentration of IL-1 beta (IL-1 F2) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-1 ra (IL-1 F3)3 yearsConcentration of IL-1 ra (IL-1 F3) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-1 ra (IL-1 F3) in the cell models of disease-TCM syndrome3 yearsConcentration of IL-1 ra (IL-1 F3) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-23 yearsConcentration of IL-2 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-2 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-2 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-43 yearsConcentration of IL-4 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-4 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-4 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-53 yearsConcentration of IL-5 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-5 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-5 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-63 yearsConcentration of IL-6 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-6 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-6 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-6R3 yearsConcentration of IL-6R will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-6R in the cell models of disease-TCM syndrome3 yearsConcentration of IL-6R will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-73 yearsConcentration of IL-7 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-7 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-7 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-8(CXCL8)3 yearsConcentration of IL-8(CXCL8) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-8(CXCL8) in the cell models of disease-TCM syndrome3 yearsConcentration of IL-8(CXCL8) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-103 yearsConcentration of IL-10 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-10 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-10 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-113 yearsConcentration of IL-11 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-11 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-11 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-12 p403 yearsConcentration of IL-12 p40 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-12 p40 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-12 p40 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-12 p703 yearsConcentration of IL-12 p70 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-12 p70 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-12 p70 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-133 yearsConcentration of IL-13 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-13 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-13 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-153 yearsConcentration of IL-15 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of IL-15 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-15 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-163 yearsConcentration of IL-16 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Routine Blood Examination (Concentration of WBC, LYMPH%, MONO, NEUT%, LYMPH, MONO%, NEUT, BASO%, BASO, MCH, MCHC,ROW-CV, MPV, PLT, PDW, EO%, P-LCR, RBC, Hb, HCT)3 yearsLKD group, PBS group and NC group's Routine Blood Examination will be detect by automated hematology analyzer.
Concentration of IL-16 in the cell models of disease-TCM syndrome3 yearsConcentration of IL-16 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of IL-17A3 yearsConcentration of IL-17A will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of Blood Biochemistry (Concentration of TC, TG, HDL-C, LDL-C, Urea, Cr, UA, GLu, ALT, AST, TP, ALB, ALP, GGT, TBIL, DBIL, Mg, K, Na, Cl, Ca, P, Fe, CO2)3 yearsLKD group, PBS group and NC group's Blood Biochemistry will be detect by automatic biochemical analyzer.
Concentration of IL-17A in the cell models of disease-TCM syndrome3 yearsConcentration of IL-17A will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MCP-1 (CCL2)3 yearsConcentration of MCP-1 (CCL2) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MCP-1 (CCL2) in the cell models of disease-TCM syndrome3 yearsConcentration of MCP-1 (CCL2) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of M-CSF3 yearsConcentration of M-CSF will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of M-CSF in the cell models of disease-TCM syndrome3 yearsConcentration of M-CSF will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIG (CXCL9)3 yearsConcentration of MIG (CXCL9) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIG (CXCL9) in the cell models of disease-TCM syndrome3 yearsConcentration of MIG (CXCL9) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIP-13 yearsConcentration of MIP-1 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 in the cell models of disease-TCM syndrome3 yearsConcentration of MIP-1 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of alpha (CCL3) in the cell models of disease-TCM syndrome3 yearsConcentration of alpha (CCL3) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of alpha (CCL3)3 yearsConcentration of alpha (CCL3) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 beta (CCL4)3 yearsConcentration of MIP-1 beta (CCL4) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 beta (CCL4) in the cell models of disease-TCM syndrome3 yearsConcentration of MIP-1 beta (CCL4) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of MIP-1 delta (CCL15)3 yearsConcentration of MIP-1 delta (CCL15) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of MIP-1 delta (CCL15) in the cell models of disease-TCM syndrome3 yearsConcentration of MIP-1 delta (CCL15) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of PDGF-BB3 yearsConcentration of PDGF-BB will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of PDGF-BB in the cell models of disease-TCM syndrome3 yearsConcentration of PDGF-BB will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Routine Urine Examination (Concentration of LEU, NIT, PRO, GLU-U, KET, URO, BIL, PH-U, SG, BLU)3 yearsLKD group, PBS group and NC group's Routine Urine Examination will be detect by Urine analyzer.
Concentration of RANTES (CCL5)3 yearsConcentration of RANTES (CCL5) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of RANTES (CCL5) in the cell models of disease-TCM syndrome3 yearsConcentration of RANTES (CCL5) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TIMP-13 yearsConcentration of TIMP-1 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TIMP-1 in the cell models of disease-TCM syndrome3 yearsConcentration of TIMP-1 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TIMP-23 yearsConcentration of TIMP-2 will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TIMP-2 in the cell models of disease-TCM syndrome3 yearsConcentration of TIMP-2 will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF alpha3 yearsConcentration of TNF alpha will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF alpha in the cell models of disease-TCM syndrome3 yearsConcentration of TNF alpha will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF beta (TNFSF1B)3 yearsConcentration of TNF beta (TNFSF1B) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF beta (TNFSF1B) in the cell models of disease-TCM syndrome3 yearsConcentration of TNF beta (TNFSF1B) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF RI (TNFRSF1A)3 yearsConcentration of TNF RI (TNFRSF1A) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF RI (TNFRSF1A) in the cell models of disease-TCM syndrome3 yearsConcentration of TNF RI (TNFRSF1A) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of TNF RII(TNFRSF1B)3 yearsConcentration of TNF RII(TNFRSF1B) will be detected by ELISA in LKD group, PBS group and NC group.
Concentration of TNF RII(TNFRSF1B) in the cell models of disease-TCM syndrome3 yearsConcentration of TNF RII(TNFRSF1B) will be detected by ELISA in the cell models of disease-TCM syndrome.
Concentration of Signaling pathway indicator3 yearsConcentration of Signaling pathway indicator will be detected by ELISA, metabonomics, proteomics, transcriptomics in LKD group, PBS group and NC group.
Concentration of Signaling pathway indicator in the cell models of disease-TCM syndrome3 yearsConcentration of Signaling pathway indicator will be detected by ELISA, metabonomics, proteomics, transcriptomics in the cell models of disease-TCM syndrome.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026