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Trial record 31 of 3342 for:    China Medicine University Hospital

The Efficacy of TGF for Treating Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT03562429
Recruitment Status : Not yet recruiting
First Posted : June 19, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Hen-Hong Chang, China Medical University Hospital

Brief Summary:

This study is to evaluate the efficacy of herbal formula TGF treating knee joint osteoarthritis(KOA) and its biochemical mechanism. The study design is a parallel randomized, placebo-controlled, double-blind clinical trial includes 180 patients with KOA. The patients are random allocated into study group(taking TGF) and control group(taking 1/20 TGF). After the 12 weeks treatment course, another 4 weeks is to follow-up the condition without medication. Assessments will be performed before and after treatment and the end of follow-up period.

The inclusion criteria are (1) age between 50~75 years old, (2) diagnosis of osteoarthritis: The Clinical/Radiographic classification criteria of American College of Rheumatology, American College of Rheumatology, (3) chronic knee pain over 3 months. The exclusion criteria are (1) the past history with systemic joint disease, such as autoimmune disease, (2) the patient with history of knee surgery or waiting for the total knee replacement, (3) any disease that affect the function of lower extremities, such as trauma, tumor or compensation of abnormal posture, (4) the condition that cannot participate this study, (5) the subjects non-compliance with the protocol.

The Assessments including primarily the WOMAC (VAS version, 3.1), VAS and the used dosage of Celebrex before and after treatment. The secondary assessments are (1) X ray, (2) Constitution in Chinese Medicine Questionnaire, (3) Short From-36, (4) erythrocyte sedimentation rate and C reactive protein, (5) Biomarkers: C-telopeptide of type II collagen, cartilage oligomeric matrix protein, Osteocalcin, Leptin, Interleukin-1, Interleukin-6, matrix metalloproteinase-3, matrix metalloproteinase-13, ADAMTS-4, transglutaminase-2, and (6) metabolomics.


Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: TGF Drug: TGFP Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 180 subjects are divided into treatment group and control group (placebo).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of TGF for Treating Osteoarthritis of the Knee: A Randomized Double-blind Controlled Trial
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: TGF group (study group)
Use TGF to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.
Drug: TGF
TGF is a powder formulation of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..
Other Name: Hu-Qian Wan

Placebo Comparator: TGFP group (placebo group)
Use TGFP to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.
Drug: TGFP
TGFP is 1/20 concentration of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..
Other Name: the placebo of Hu-Qian Wan




Primary Outcome Measures :
  1. Western Ontario & McMaster Universities Osteoarthritis Index [ Time Frame: Change from Baseline WOMAC VAS version 3.1 at 3 months ]
    This scale is the VAS version, 3.1 and divided into three sub-scales -- pain, stiffness and function. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing. Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item has 0-100 mm to evaluate the status and the higher values represent a worse outcome. These three sub-scales were summed to a total score (0-2400 mm).

  2. Visual Analogue Scale for pain [ Time Frame: Change from Baseline Visual Analogue Scale for pain at 3 months ]
    To evaluate the status of knee pain when check point. Using 0-100 mm scale is to evaluate knee pain by visual analogue scale. "0" is no pain and "100" is the worst pain that subjects had experienced before. The subject gives the value under the moment of check point.

  3. the used dosage of Celebrex [ Time Frame: Change from Baseline the used dosage of Celebrex at 3 months ]
    To evaluate the dosage of Celebrex when check point

  4. Western Ontario & McMaster Universities Osteoarthritis Index [ Time Frame: Change from Baseline WOMAC VAS version 3.1 at 4 months ]
    This scale is the VAS version, 3.1 and divided into three sub-scales -- pain, stiffness and function. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing. Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item has 0-100 mm to evaluate the status and the higher values represent a worse outcome. These three sub-scales were summed to a total score (0-2400 mm).

  5. Visual Analogue Scale for pain [ Time Frame: Change from Baseline Visual Analogue Scale for pain at 4 months ]
    To evaluate the status of knee pain when check point. Using 0-100 mm scale is to evaluate knee pain by visual analogue scale. "0" is no pain and "100" is the worst pain that subjects had experienced before. The subject gives the value under the moment of check point.

  6. the used dosage of Celebrex [ Time Frame: Change from Baseline the used dosage of Celebrex at 4 months ]
    To evaluate the dosage of Celebrex when check point


Secondary Outcome Measures :
  1. X ray [ Time Frame: Change from Baseline X ray at 3 months ]
    knee joint that associated with this study

  2. X ray [ Time Frame: Change from Baseline X ray at 4 months ]
    knee joint that associated with this study

  3. Constitution in Chinese Medicine Questionnaire, CCMQ [ Time Frame: Change from Baseline CCMQ at 3 months ]
    For evaluating the constitution. This scale (Constitution in Chinese Medicine Questionnaire) includes nine constitutions and each constitution has 6-8 items that used 1-5 points to evaluate the degree. "1" means "better" and "5" means "worse". The transformed points is equal to [(original points - the number of items)/(the number of itmes*4) ]*100.

  4. Constitution in Chinese Medicine Questionnaire, CCMQ [ Time Frame: Change from Baseline CCMQ at 4 months ]
    For evaluating the constitution. This scale (Constitution in Chinese Medicine Questionnaire) includes nine constitutions and each constitution has 6-8 items that used 1-5 points to evaluate the degree. "1" means "better" and "5" means "worse". The transformed points is equal to [(original points - the number of items)/(the number of itmes*4) ]*100.

  5. WHOQOL-BREF [ Time Frame: Change from Baseline WHOQOL at 3 months ]
    For evaluating the quality of life. This scale is "World Health Organization Quality of Life - BREF". It contains 4 domains (Physical health, Psychological, Social relationships and Environment) and 26 items ("1" means "worse" and "5" means "better"). This scale used the following steps to calculate the transformed points: 1.Check all 26 items from assessment have a range of 1-5, 2.Reverse 3 negatively phrased items, 3.Compute domain scores, 4. Delete cases with >20% missing data, 5.Check domain scores.

  6. WHOQOL [ Time Frame: Change from Baseline WHOQOL at 4 months ]
    For evaluating the quality of life. This scale is "World Health Organization Quality of Life - BREF". It contains 4 domains (Physical health, Psychological, Social relationships and Environment) and 26 items ("1" means "worse" and "5" means "better"). This scale used the following steps to calculate the transformed points: 1.Check all 26 items from assessment have a range of 1-5, 2.Reverse 3 negatively phrased items, 3.Compute domain scores, 4. Delete cases with >20% missing data, 5.Check domain scores.

  7. ESR [ Time Frame: Change from Baseline ESR at 3 months ]
    For evaluating the status of inflammation. Erythrocyte Sedimentation Rate (ESR) actually measures the rate of fall (sedimentation) of erythrocytes (red blood cells) in a sample of blood that has been placed into a tube. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The higher value means more inflammation.

  8. ESR [ Time Frame: Change from Baseline ESR at 4 months ]
    For evaluating the status of inflammation. Erythrocyte Sedimentation Rate (ESR) actually measures the rate of fall (sedimentation) of erythrocytes (red blood cells) in a sample of blood that has been placed into a tube. Results are reported as the millimeters of clear fluid (plasma) that are present at the top portion of the tube after one hour. The higher value means more inflammation.

  9. CTX-II [ Time Frame: Change from Baseline CTX-II at 3 months ]
    This study uses ELISA kit to measure the concentraion (pg/ml) of C-Telopeptide of Type II Collagen (CTX-II) .

  10. CTX-II [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (pg/ml) of C-Telopeptide of Type II Collagen (CTX-II) .

  11. COMP [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of Cartilage Oligomeric Matrix Protein (COMP) .

  12. COMP [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of Cartilage Oligomeric Matrix Protein (COMP) .

  13. Osteocalcin [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of Osteocalcin .

  14. Osteocalcin [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of Osteocalcin .

  15. Leptin [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (pg/ml) of Leptin.

  16. Leptin [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (pg/ml) of Leptin.

  17. IL-1 [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-1 (IL-1).

  18. IL-1 [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-1 (IL-1).

  19. IL-6 [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-6 (IL-6).

  20. IL-6 [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of interleukin-6 (IL-6).

  21. MMP-3 [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of matrix metalloproteinase-3 (MMP-3).

  22. MMP-3 [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of matrix metalloproteinase-3 (MMP-3).

  23. MMP-13 [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (pg/ml) of matrix metalloproteinase-13 (MMP-13).

  24. MMP-13 [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (pg/ml) of matrix metalloproteinase-13 (MMP-13).

  25. ADAMTS-4 [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4).

  26. ADAMTS-4 [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of a disintegrin and metalloproteinase with thrombospondin motifs-4 (ADAMTS-4).

  27. TG-2 [ Time Frame: Change from Baseline biomarkers at 3 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of Transglutaminase 2 (TG-2).

  28. TG-2 [ Time Frame: Change from Baseline biomarkers at 4 months ]
    This study uses ELISA kit to measure the concentraion (ng/ml) of Transglutaminase 2 (TG-2).

  29. Metabolomics [ Time Frame: Change from Baseline metabolomics at 3 months ]
    The metabolite of the drugs. This measurement used LC-MS to get the molecular weight of Chinese herbal metabolites form blood, urine and synovial fluid. This method can help to identify the active substance from the formula (TGF). Here, we cannot to know the exactly active substance that we will get.

  30. Metabolomics [ Time Frame: Change from Baseline metabolomics at 4 months ]
    The metabolite of the drugs. This measurement used LC-MS to get the molecular weight of Chinese herbal metabolites form blood, urine and synovial fluid. This method can help to identify the active substance from the formula (TGF). Here, we cannot to know the exactly active substance that we will get.

  31. Mitochondria research--mtDNA copy number [ Time Frame: Change from Baseline mtDNA copy number at 3 months ]
    mtDNA copy number

  32. Mitochondria research--mtDNA copy number [ Time Frame: Change from Baseline mtDNA copy number at 4 months ]
    mtDNA copy number

  33. Mitochondria research--the expression of messenger ribonucleic acid in Peroxisome proliferator-activated receptor-γ coactivator-1α [ Time Frame: Change from Baseline the expression of mRNA in PGC-1α at 3 months ]
    the expression of mRNA in PGC-1α by quantitative polymerase chain reaction

  34. Mitochondria research--the expression of messenger ribonucleic acid in Peroxisome proliferator-activated receptor-γ coactivator-1α [ Time Frame: Change from Baseline the expression of mRNA in PGC-1α at 4 months ]
    the expression of mRNA in PGC-1α by quantitative polymerase chain reaction

  35. Mitochondria research--the expression of messenger ribonucleic acid in Nuclear respiratory factor 1 [ Time Frame: Change from Baseline the expression of mRNA in NRF1 at 3 months ]
    the expression of mRNA in NRF1 by quantitative polymerase chain reaction

  36. Mitochondria research--the expression of messenger ribonucleic acid in Nuclear respiratory factor 1 [ Time Frame: Change from Baseline the expression of mRNA in NRF1 at 4 months ]
    the expression of mRNA in NRF1 by quantitative polymerase chain reaction

  37. Mitochondria research--the expression of messenger ribonucleic acid in mtTFA [ Time Frame: Change from Baseline the expression of mRNA in mtTFA at 3 months ]
    the expression of mRNA in mtTFA by quantitative polymerase chain reaction

  38. Mitochondria research--the expression of messenger ribonucleic acid in mtTFA [ Time Frame: Change from Baseline the expression of mRNA in mtTFA at 4 months ]
    the expression of mRNA in mtTFA by quantitative polymerase chain reaction

  39. Mitochondria research--the expression of protein in Peroxisome proliferator-activated receptor-γ coactivator-1α [ Time Frame: Change from Baseline the expression of protein in PGC-1α at 3 months ]
    the expression of protein in PGC-1α by Western blotting

  40. Mitochondria research--the expression of protein in Peroxisome proliferator-activated receptor-γ coactivator-1α [ Time Frame: Change from Baseline the expression of protein in PGC-1α at 4 months ]
    the expression of protein in PGC-1α by Western blotting

  41. Mitochondria research--the expression of protein in Nuclear respiratory factor 1 [ Time Frame: Change from Baseline the expression of protein in NRF1 at 3 months ]
    the expression of protein in NRF1 by Western blotting

  42. Mitochondria research--the expression of protein in Nuclear respiratory factor 1 [ Time Frame: Change from Baseline the expression of protein in NRF1 at 4 months ]
    the expression of protein in NRF1 by Western blotting

  43. Mitochondria research--the expression of protein in mtTFA [ Time Frame: Change from Baseline the expression of protein in mtTFA at 3 months ]
    the expression of protein in mtTFA by Western blotting

  44. Mitochondria research--the expression of protein in mtTFA [ Time Frame: Change from Baseline the expression of protein in mtTFA at 4 months ]
    the expression of protein in mtTFA by Western blotting

  45. Mitochondria research--anti-oxidant capacity [ Time Frame: Change from Baseline anti-oxidant capacity at 3 months ]
    anti-oxidant capacity by OxiSelectTM Trolox Equivalent Antioxidant Capacity (TEAC) Assay Kit (ABTS)

  46. Mitochondria research--anti-oxidant capacity [ Time Frame: Change from Baseline anti-oxidant capacity at 4 months ]
    anti-oxidant capacity by OxiSelectTM Trolox Equivalent Antioxidant Capacity (TEAC) Assay Kit (ABTS)

  47. hsCRP [ Time Frame: Change from Baseline CRP at 3 months ]
    For evaluating the status of inflammation. High-sensitivity C-reactive Protein is a protein that increases in the blood with inflammation and infection as well as following a heart attack, surgery, or trauma. Thus, it is one of several proteins that are often referred to as acute phase reactants. The high-sensitivity CRP test measures low levels of CRP in the blood to identify low levels of inflammation that are associated with risk of developing cardiovascular disease (CVD).

  48. hsCRP [ Time Frame: Change from Baseline CRP at 4 months ]
    For evaluating the status of inflammation. High-sensitivity C-reactive Protein is a protein that increases in the blood with inflammation and infection as well as following a heart attack, surgery, or trauma. Thus, it is one of several proteins that are often referred to as acute phase reactants. The high-sensitivity CRP test measures low levels of CRP in the blood to identify low levels of inflammation that are associated with risk of developing cardiovascular disease (CVD).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age between 50~75 years old
  2. diagnosis of osteoarthritis: The Clinical/Radiographic classification criteria of American College of Rheumatology, ACR
  3. chronic knee pain over 3 months.

Exclusion Criteria:

  1. the past history with systemic joint disease, such as autoimmune disease
  2. the patient with history of knee surgery or waiting for the total knee replacement
  3. any disease that affect the function of lower extremities, such as trauma, tumor or compensation of abnormal posture
  4. the condition that cannot participate this study
  5. the subjects non-compliance with the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562429


Contacts
Layout table for location contacts
Contact: Hen-Hong Chang 886-4-22053366 ext 3001 tcmchh55@gmail.com

Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: Hen-Hong Chang Dean of Chinese medicine, China Medical University

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Responsible Party: Hen-Hong Chang, Professor, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03562429     History of Changes
Other Study ID Numbers: CMUH107-REC2-044
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases