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AzTrials

Knee OsteoarthritisNCT05218122

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

An observational study of Knee Osteoarthritis and Syndrome, run by Dongzhimen Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
What is being tested?
cross-sectional study without intervention
How many people
340 participants
Where
1 siteChina
Study dates
24 Dec 2021to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Among the outpatients and inpatients in Dongzhimen Hospital of Beijing University of traditional Chinese medicine from December 2021 to August 2024, 150 cases of liver and kidney deficiency syndrome and 300 cases of phlegm and blood stasis syndrome were taken respectively. All patients met the diagnosis of knee osteoarthritis and met the inclusion criteria. Another 40 cases of normal control group were taken.

Who may be able to join

  • 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;
  • Inclusion criteria of normal control group
Show all 10Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Dongzhimen Hospital

    Beijing, Beijing Municipality, 100700

    Rui Zheng, +8601084012709, yechao@bucm.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

  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.
Read the 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.
Being tested
cross-sectional study without intervention
Keywords
TGF-β/Smad signaling pathway, disease and syndrome cell model, knee osteoarthritis, syndrome, traditional Chinese medicine
Medical subject headings
Osteoarthritis, Knee, Syndrome, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cross-sectional study without interventionOther

    cross-sectional study without intervention

Study groups in NCT05218122
Study groupRoleWhat they receive
LKD syndromeliver and kidney deficiency syndrome
Receives: Other: cross-sectional study without intervention
PBS syndromephlegm and blood stasis syndrome
Receives: Other: cross-sectional study without intervention
NC groupNormal Control group
Receives: Other: cross-sectional study without intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 years

  3. 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.

    Measured: 3 years

  4. 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.

    Measured: 3 years

  5. 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.

    Measured: 3 years

  6. 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.

    Measured: 3 years

  7. the related indexes of TGF- β/ Smad signaling pathway and inflammatory response

    Histological and pathological examination is used to detect the related indexes of TGF- β/ Smad signaling pathway and inflammatory response.

    Measured: 3 years

  8. The clinical TCM scores of LKD

    The minimum value is 0 and maximum value is 38, and higher scores mean a worse outcome.

    Measured: 3 years

  9. The clinical TCM scores of PBS

    The minimum value is 0 and maximum value is 41, and higher scores mean a worse outcome.

    Measured: 3 years

  10. 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.

    Measured: 3 years

  11. The grading scores of Yulish

    The minimum value is 0 and maximum value is 4, and higher scores mean a worse outcome.

    Measured: 3 years

  12. 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.

    Measured: 3 years

  13. Concentration of BLC (CXCL13)

    Concentration of BLC (CXCL13) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  14. 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.

    Measured: 3 years

  15. 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.

    Measured: 3 years

  16. 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.

    Measured: 3 years

  17. 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.

    Measured: 3 years

  18. 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.

    Measured: 3 years

  19. Concentration of GCSF

    Concentration of GCSF will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  20. 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.

    Measured: 3 years

  21. Concentration of GM-CSF

    Concentration of GM-CSF will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  22. 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.

    Measured: 3 years

  23. 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.

    Measured: 3 years

  24. 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.

    Measured: 3 years

  25. Concentration of ICAM-1(CD54)

    Concentration of ICAM-1(CD54) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  26. 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.

    Measured: 3 years

  27. Concentration of IFN-gamma

    Concentration of IFN-gamma will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  28. 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.

    Measured: 3 years

  29. 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.

    Measured: 3 years

  30. 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.

    Measured: 3 years

  31. 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.

    Measured: 3 years

  32. 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.

    Measured: 3 years

  33. 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.

    Measured: 3 years

  34. 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.

    Measured: 3 years

  35. Concentration of IL-2

    Concentration of IL-2 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  36. 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.

    Measured: 3 years

  37. Concentration of IL-4

    Concentration of IL-4 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  38. 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.

    Measured: 3 years

  39. Concentration of IL-5

    Concentration of IL-5 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  40. 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.

    Measured: 3 years

  41. Concentration of IL-6

    Concentration of IL-6 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  42. 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.

    Measured: 3 years

  43. Concentration of IL-6R

    Concentration of IL-6R will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  44. 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.

    Measured: 3 years

  45. Concentration of IL-7

    Concentration of IL-7 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  46. 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.

    Measured: 3 years

  47. Concentration of IL-8(CXCL8)

    Concentration of IL-8(CXCL8) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  48. 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.

    Measured: 3 years

  49. Concentration of IL-10

    Concentration of IL-10 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  50. 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.

    Measured: 3 years

  51. Concentration of IL-11

    Concentration of IL-11 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  52. 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.

    Measured: 3 years

  53. Concentration of IL-12 p40

    Concentration of IL-12 p40 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  54. 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.

    Measured: 3 years

  55. Concentration of IL-12 p70

    Concentration of IL-12 p70 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  56. 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.

    Measured: 3 years

  57. Concentration of IL-13

    Concentration of IL-13 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  58. 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.

    Measured: 3 years

  59. Concentration of IL-15

    Concentration of IL-15 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  60. 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.

    Measured: 3 years

  61. Concentration of IL-16

    Concentration of IL-16 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  62. 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.

    Measured: 3 years

  63. Concentration of IL-17A

    Concentration of IL-17A will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  64. 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.

    Measured: 3 years

  65. Concentration of MCP-1 (CCL2)

    Concentration of MCP-1 (CCL2) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  66. 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.

    Measured: 3 years

  67. Concentration of M-CSF

    Concentration of M-CSF will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  68. 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.

    Measured: 3 years

  69. Concentration of MIG (CXCL9)

    Concentration of MIG (CXCL9) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  70. 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.

    Measured: 3 years

  71. Concentration of MIP-1

    Concentration of MIP-1 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  72. 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.

    Measured: 3 years

  73. 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.

    Measured: 3 years

  74. Concentration of alpha (CCL3)

    Concentration of alpha (CCL3) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  75. 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.

    Measured: 3 years

  76. 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.

    Measured: 3 years

  77. 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.

    Measured: 3 years

  78. 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.

    Measured: 3 years

  79. Concentration of PDGF-BB

    Concentration of PDGF-BB will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  80. 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.

    Measured: 3 years

  81. Concentration of RANTES (CCL5)

    Concentration of RANTES (CCL5) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  82. 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.

    Measured: 3 years

  83. Concentration of TIMP-1

    Concentration of TIMP-1 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  84. 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.

    Measured: 3 years

  85. Concentration of TIMP-2

    Concentration of TIMP-2 will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  86. 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.

    Measured: 3 years

  87. Concentration of TNF alpha

    Concentration of TNF alpha will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  88. 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.

    Measured: 3 years

  89. Concentration of TNF beta (TNFSF1B)

    Concentration of TNF beta (TNFSF1B) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  90. 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.

    Measured: 3 years

  91. Concentration of TNF RI (TNFRSF1A)

    Concentration of TNF RI (TNFRSF1A) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  92. 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.

    Measured: 3 years

  93. Concentration of TNF RII(TNFRSF1B)

    Concentration of TNF RII(TNFRSF1B) will be detected by ELISA in LKD group, PBS group and NC group.

    Measured: 3 years

  94. 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.

    Measured: 3 years

  95. 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.

    Measured: 3 years

  96. 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.

    Measured: 3 years

  97. 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.

    Measured: 3 years

  98. 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.

    Measured: 3 years

  99. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start24 Dec 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218122
Sponsor's protocol ID
2021DZMEC-139-03
Status last verified
Jan 2022
First submitted
27 Dec 2021
Last updated
1 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis and Syndrome, run by Dongzhimen Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the differences of metabonomics (time frame: 3 years). The study lists 99 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.

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