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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05218122
Other study ID # 2021DZMEC-139-03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 24, 2021
Est. completion date December 31, 2024

Study information

Verified date January 2022
Source Dongzhimen Hospital, Beijing
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Other:
cross-sectional study without intervention
cross-sectional study without intervention

Locations

Country Name City State
China Dongzhimen Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the differences of metabonomics The differences of metabonomics in blood, urine and tongue coating will be detected by metabonomics in LKD group, PBS group and NC group. 3 years
Primary the differences of metabonomics in the cell models of disease-TCM syndrome The differences of metabonomics in the cell models of disease-TCM syndrome will be detected by metabonomics. 3 years
Primary the differences of proteomics in the cell models of disease-TCM syndrome The differences of proteomics in the cell models of disease-TCM syndrome will be detected by proteomics. 3 years
Primary the differences of proteomics The differences of proteomics in blood, urine and tongue coating will be detected by proteomics in LKD group, PBS group and NC group. 3 years
Primary the differences of transcriptomics The differences of transcriptomics in blood, urine and tongue coating will be detected by transcriptomics in LKD group, PBS group and NC group. 3 years
Primary the differences of transcriptomics in the cell models of disease-TCM syndrome The differences of transcriptomics in the cell models of disease-TCM syndrome will be detected by transcriptomics. 3 years
Primary the related indexes of TGF- ß/ Smad signaling pathway and inflammatory response Histological and pathological examination is used to detect the related indexes of TGF- ß/ Smad signaling pathway and inflammatory response. 3 years
Primary The clinical TCM scores of LKD The minimum value is 0 and maximum value is 38, and higher scores mean a worse outcome. 3 years
Primary The clinical TCM scores of PBS The minimum value is 0 and maximum value is 41, and higher scores mean a worse outcome. 3 years
Primary The grading scores of Kellgren Lawrence (K-L) The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome. 3 years
Primary The grading scores of Yulish The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome. 3 years
Primary Clinical data Collect 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. 3 years
Primary Concentration of BLC (CXCL13) Concentration of BLC (CXCL13) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of BLC (CXCL13) in the cell models of disease-TCM syndrome Concentration of BLC (CXCL13) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of Eotaxin-1 (CCL11) Concentration of Eotaxin-1 (CCL11) will be detected by ELISA will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of Eotaxin-1 (CCL11) in the cell models of disease-TCM syndrome Concentration of Eotaxin-1 (CCL11) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of Eotaxin-2 (MPIF-2/CCL24) Concentration of Eotaxin-2 (MPIF-2/CCL24) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of Eotaxin-2 (MPIF-2/CCL24) in the cell models of disease-TCM syndrome Concentration of Eotaxin-2 (MPIF-2/CCL24) will be detected by ELISA in the cell models of disease-TCM. 3 years
Primary Concentration of GCSF Concentration of GCSF will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of GCSF in the cell models of disease-TCM syndrome Concentration of GCSF will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of GM-CSF Concentration of GM-CSF will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of GM-CSF in the cell models of disease-TCM syndrome Concentration of GM-CSF will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of I-309 (TCA-3/CCL1) Concentration of I-309 (TCA-3/CCL1) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of I-309 (TCA-3/CCL1) in the cell models of disease-TCM syndrome Concentration of I-309 (TCA-3/CCL1) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of ICAM-1(CD54) Concentration of ICAM-1(CD54) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of ICAM-1(CD54) in the cell models of disease-TCM syndrome Concentration of ICAM-1(CD54) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IFN-gamma Concentration of IFN-gamma will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IFN-gamma in the cell models of disease-TCM syndrome Concentration of IFN-gamma will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-1 alpha (IL-1 F1) Concentration of IL-1 alpha (IL-1 F1) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-1 alpha (IL-1 F1) in the cell models of disease-TCM syndrome Concentration of IL-1 alpha (IL-1 F1) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-1 beta (IL-1 F2) Concentration of IL-1 beta (IL-1 F2) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-1 beta (IL-1 F2) in the cell models of disease-TCM syndrome Concentration of IL-1 beta (IL-1 F2) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-1 ra (IL-1 F3) Concentration of IL-1 ra (IL-1 F3) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-1 ra (IL-1 F3) in the cell models of disease-TCM syndrome Concentration of IL-1 ra (IL-1 F3) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-2 Concentration of IL-2 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-2 in the cell models of disease-TCM syndrome Concentration of IL-2 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-4 Concentration of IL-4 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-4 in the cell models of disease-TCM syndrome Concentration of IL-4 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-5 Concentration of IL-5 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-5 in the cell models of disease-TCM syndrome Concentration of IL-5 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-6 Concentration of IL-6 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-6 in the cell models of disease-TCM syndrome Concentration of IL-6 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-6R Concentration of IL-6R will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-6R in the cell models of disease-TCM syndrome Concentration of IL-6R will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-7 Concentration of IL-7 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-7 in the cell models of disease-TCM syndrome Concentration of IL-7 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-8(CXCL8) Concentration of IL-8(CXCL8) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-8(CXCL8) in the cell models of disease-TCM syndrome Concentration of IL-8(CXCL8) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-10 Concentration of IL-10 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-10 in the cell models of disease-TCM syndrome Concentration of IL-10 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-11 Concentration of IL-11 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-11 in the cell models of disease-TCM syndrome Concentration of IL-11 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-12 p40 Concentration of IL-12 p40 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-12 p40 in the cell models of disease-TCM syndrome Concentration of IL-12 p40 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-12 p70 Concentration of IL-12 p70 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-12 p70 in the cell models of disease-TCM syndrome Concentration of IL-12 p70 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-13 Concentration of IL-13 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-13 in the cell models of disease-TCM syndrome Concentration of IL-13 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-15 Concentration of IL-15 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-15 in the cell models of disease-TCM syndrome Concentration of IL-15 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-16 Concentration of IL-16 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-16 in the cell models of disease-TCM syndrome Concentration of IL-16 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of IL-17A Concentration of IL-17A will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of IL-17A in the cell models of disease-TCM syndrome Concentration of IL-17A will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of MCP-1 (CCL2) Concentration of MCP-1 (CCL2) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of MCP-1 (CCL2) in the cell models of disease-TCM syndrome Concentration of MCP-1 (CCL2) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of M-CSF Concentration of M-CSF will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of M-CSF in the cell models of disease-TCM syndrome Concentration of M-CSF will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of MIG (CXCL9) Concentration of MIG (CXCL9) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of MIG (CXCL9) in the cell models of disease-TCM syndrome Concentration of MIG (CXCL9) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of MIP-1 Concentration of MIP-1 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of MIP-1 in the cell models of disease-TCM syndrome Concentration of MIP-1 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of alpha (CCL3) in the cell models of disease-TCM syndrome Concentration of alpha (CCL3) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of alpha (CCL3) Concentration of alpha (CCL3) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of MIP-1 beta (CCL4) Concentration of MIP-1 beta (CCL4) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of MIP-1 beta (CCL4) in the cell models of disease-TCM syndrome Concentration of MIP-1 beta (CCL4) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of MIP-1 delta (CCL15) Concentration of MIP-1 delta (CCL15) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of MIP-1 delta (CCL15) in the cell models of disease-TCM syndrome Concentration of MIP-1 delta (CCL15) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of PDGF-BB Concentration of PDGF-BB will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of PDGF-BB in the cell models of disease-TCM syndrome Concentration of PDGF-BB will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of RANTES (CCL5) Concentration of RANTES (CCL5) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of RANTES (CCL5) in the cell models of disease-TCM syndrome Concentration of RANTES (CCL5) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of TIMP-1 Concentration of TIMP-1 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of TIMP-1 in the cell models of disease-TCM syndrome Concentration of TIMP-1 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of TIMP-2 Concentration of TIMP-2 will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of TIMP-2 in the cell models of disease-TCM syndrome Concentration of TIMP-2 will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of TNF alpha Concentration of TNF alpha will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of TNF alpha in the cell models of disease-TCM syndrome Concentration of TNF alpha will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of TNF beta (TNFSF1B) Concentration of TNF beta (TNFSF1B) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of TNF beta (TNFSF1B) in the cell models of disease-TCM syndrome Concentration of TNF beta (TNFSF1B) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of TNF RI (TNFRSF1A) Concentration of TNF RI (TNFRSF1A) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of TNF RI (TNFRSF1A) in the cell models of disease-TCM syndrome Concentration of TNF RI (TNFRSF1A) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of TNF RII(TNFRSF1B) Concentration of TNF RII(TNFRSF1B) will be detected by ELISA in LKD group, PBS group and NC group. 3 years
Primary Concentration of TNF RII(TNFRSF1B) in the cell models of disease-TCM syndrome Concentration of TNF RII(TNFRSF1B) will be detected by ELISA in the cell models of disease-TCM syndrome. 3 years
Primary Concentration of Signaling pathway indicator Concentration of Signaling pathway indicator will be detected by ELISA, metabonomics, proteomics, transcriptomics in LKD group, PBS group and NC group. 3 years
Primary Concentration of Signaling pathway indicator in the cell models of disease-TCM syndrome Concentration of Signaling pathway indicator will be detected by ELISA, metabonomics, proteomics, transcriptomics in the cell models of disease-TCM syndrome. 3 years
Primary 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) LKD group, PBS group and NC group's Routine Blood Examination will be detect by automated hematology analyzer. 3 years
Primary 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) LKD group, PBS group and NC group's Blood Biochemistry will be detect by automatic biochemical analyzer. 3 years
Primary Concentration of Routine Urine Examination (Concentration of LEU, NIT, PRO, GLU-U, KET, URO, BIL, PH-U, SG, BLU) LKD group, PBS group and NC group's Routine Urine Examination will be detect by Urine analyzer. 3 years
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