Inflammation, Knee Pain Chronic
Conditions
Keywords
Non-denatured type II collagen, Glucosamine, Curcumin, Knee Pain
Brief summary
This research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.
Detailed description
Arthritis is an inflammation of one or more joints, characterized by pain, stiffness (especially in the early morning or after exercise), swelling, deformation, and/or reduced mobility. There are many different forms of arthritis. Osteoarthritis, also known as degenerative arthritis, is caused by abnormal damage to the cartilage at the ends of bones. In some patients, it is caused by injury or congenital abnormalities in the proteins that make up cartilage. Generally, it seems that aging, an unbalanced diet, and an inappropriate lifestyle are the causes of this disease. Once the cartilage tissue changes from smooth to rough or breaks into small pieces, the cartilage is gradually destroyed, and the normally smooth surface becomes irregular. Osteoarthritis usually occurs in joints that bear weight, such as the spine, knees, hips, and back. It is usually preceded by pain and symptoms of stiffness (often stiffness first, then pain), but swelling is not always present. In a small number of cases, osteoarthritis can cause disability. As the condition progresses, the bones can become more fragmented, increasing the likelihood of fractures. When osteoarthritis is more severe, bones can overgrow into osteophytes, known as bone spurs. These bone spurs can be detected with X-rays, usually near degenerative cartilage in the neck or waist. However, these changes typically do not alter the appearance of the affected area. There are more than 28 types of peptides that make up collagen, with the more common types I, II, and III collagen accounting for about 90% of the total. Type II collagen forms joints. When collagen from pork bones and other sources is cooked at high temperatures, the collagen structure is destroyed, becoming denatured collagen. Additional supplements can only be used as general collagen and, therefore, cannot reduce the damage and inflammation of joint cartilage. Many studies have confirmed that the use of 'non-denatured type II collagen' (UC-II) can provide flexible maintenance for key parts. To achieve higher efficiency and longer-lasting effects, it is combined with glucosamine, chondroitin, and curcumin. In addition to providing resistance to compression in articular cartilage, it can also improve inflammation and significantly reduce pain in patients with primary osteoarthritis. Therefore, this research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.
Interventions
DIETARY_SUPPLEMENTUCII, glucosamine and curcumin
compound capsules twice daily.
DIETARY_SUPPLEMENTPlacebo
Placebo capsules twice daily.
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Knee plain
Exclusion criteria
* Severe diseases of the heart, liver, kidneys, endocrine system, and other organs * Long-term use of medication * Infection, hypertension, diabetes, cerebrovascular disease, heart disease, liver disease, kidney disease, gastrointestinal disease * Allergy to this product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Points Change of Pain Evaluation Scale | baseline, week 6, week 12 | Self-assess pain using a visual analog scale (VAS), which is a straight line 10 cm in length, with 0 cm on the left representing no pain and 10 cm on the right representing extreme pain. Explain to the subjects that the pain intensity increases from left to right. Ask the subjects to mark the point on the line that corresponds to their pain level, and then record the distance in centimeters from the 0 cm mark. Record the points that the subjects wrote. |
| Time Change of Up-and-go Test | baseline, week 6, week 12 | Timed up-and-go test (TUG) was a professional physical therapist marked a distance of 3 meters on the ground and placed an armless chair at one end. The subject sat on the chair with a straight back, and the time was measured from when the subject stood up and walked to the 3-meter mark at their usual speed, turned around, walked back, and sat down again. Shorter time spent indicates better knee function. Record the time that the subjects spent. |
| Degrees Change of Range of Motion (ROM) | baseline, week 6, week 12 | A professional physical therapist tested the active flexion and extension of the knee joint (range of motion, ROM) as the subjects attempted to achieve maximum active flexion and extension. Record the angle that the physical therapist measured. AROM: active range of motion; PROM: passive range of motion |
| Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | baseline, week 6, week 12 | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a widely used questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, and the total score was 96 points (Minimum: 0 points; Maximum: 96 points). The question content was divided into three parts: Pain (20 points), Stiffness (8 points), and Physical function (68 points). The higher score meant worse knee joint function. Record the points that the subjects got. |
| The Concentration of Serum Inflammatory Factors | baseline, week 6, week 12 | The concentration of interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and tumor necrosis factor alpha (TNF-α) in serum. |
Countries
Taiwan
Participant flow
Recruitment details
Participants were recruited from social media between August 2024 and September 2024.
Pre-assignment details
Of 32 enrolled participants, all of them met inclusion of criteria, but 2 of them were not included in the analysis because lost of follow-up.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control group use 42 mg UCII.
Placebo: Placebo capsules twice daily. | 15 |
| Test Group (UCII, Glucosamine, and Curcumin) Test group use 42 mg UCII, 460 mg glucosamine and 380 mg curcumin
UCII, glucosamine and curcumin: compound capsules twice daily. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Test Group (UCII, Glucosamine, and Curcumin) | Total | Control Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 29 Participants | 14 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 16.45 | 34.3 years STANDARD_DEVIATION 16.27 | 33.8 years STANDARD_DEVIATION 16.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 30 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 15 Participants | 30 Participants | 15 Participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 9 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Degrees Change of Range of Motion (ROM)
A professional physical therapist tested the active flexion and extension of the knee joint (range of motion, ROM) as the subjects attempted to achieve maximum active flexion and extension. Record the angle that the physical therapist measured. AROM: active range of motion; PROM: passive range of motion
Time frame: baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Degrees Change of Range of Motion (ROM) | AROM, Left Week 6 | 141.20 unit of measure: Degrees | Standard Deviation 7.88 |
| Control Group | Degrees Change of Range of Motion (ROM) | PROM, Left Baseline | 143.20 unit of measure: Degrees | Standard Deviation 7.08 |
| Control Group | Degrees Change of Range of Motion (ROM) | AROM, Right Baseline | 141.20 unit of measure: Degrees | Standard Deviation 6.7 |
| Control Group | Degrees Change of Range of Motion (ROM) | PROM, Left Week 6 | 143.07 unit of measure: Degrees | Standard Deviation 7.52 |
| Control Group | Degrees Change of Range of Motion (ROM) | AROM, Left Baseline | 141.73 unit of measure: Degrees | Standard Deviation 6.84 |
| Control Group | Degrees Change of Range of Motion (ROM) | PROM, Left Week 12 | 141.40 unit of measure: Degrees | Standard Deviation 7.67 |
| Control Group | Degrees Change of Range of Motion (ROM) | PROM, Right Baseline | 142.40 unit of measure: Degrees | Standard Deviation 6.6 |
| Control Group | Degrees Change of Range of Motion (ROM) | AROM, Right Week 6 | 140.80 unit of measure: Degrees | Standard Deviation 8.54 |
| Control Group | Degrees Change of Range of Motion (ROM) | PROM, Right Week 6 | 142.67 unit of measure: Degrees | Standard Deviation 7.95 |
| Control Group | Degrees Change of Range of Motion (ROM) | AROM, Left Week 12 | 137.93 unit of measure: Degrees | Standard Deviation 7.66 |
| Control Group | Degrees Change of Range of Motion (ROM) | PROM, Right Week 12 | 141.60 unit of measure: Degrees | Standard Deviation 7.14 |
| Control Group | Degrees Change of Range of Motion (ROM) | AROM, Right Week 12 | 138.00 unit of measure: Degrees | Standard Deviation 7.78 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | PROM, Right Week 12 | 140.13 unit of measure: Degrees | Standard Deviation 8.26 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | AROM, Left Baseline | 137.67 unit of measure: Degrees | Standard Deviation 8.35 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | AROM, Left Week 6 | 140.80 unit of measure: Degrees | Standard Deviation 8.54 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | AROM, Left Week 12 | 136.80 unit of measure: Degrees | Standard Deviation 11.03 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | AROM, Right Baseline | 138.00 unit of measure: Degrees | Standard Deviation 6.85 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | AROM, Right Week 6 | 140.67 unit of measure: Degrees | Standard Deviation 8.57 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | AROM, Right Week 12 | 138.67 unit of measure: Degrees | Standard Deviation 8.16 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | PROM, Left Baseline | 139.33 unit of measure: Degrees | Standard Deviation 8.2 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | PROM, Left Week 6 | 142.67 unit of measure: Degrees | Standard Deviation 8.27 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | PROM, Right Baseline | 139.73 unit of measure: Degrees | Standard Deviation 6.63 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | PROM, Right Week 6 | 142.67 unit of measure: Degrees | Standard Deviation 8.3 |
| Test Group (UCII, Glucosamine, and Curcumin) | Degrees Change of Range of Motion (ROM) | PROM, Left Week 12 | 138.80 unit of measure: Degrees | Standard Deviation 11.1 |
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of AROM, Left baseline, week 6, and week 12.p-value: 0.502ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of AROM, Right baseline, week 6, and week 12.p-value: 0.724ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of PROM, Left baseline, week 6, and week 12.p-value: 0.414ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of PROM, Right baseline, week 6, and week 12.p-value: 0.563ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of AROM, Left.p-value: 0.11ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of AROM, Right.p-value: 0.245ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of PROM, Left.p-value: 0.113ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of PROM, Right.p-value: 0.395ANOVA
Primary
Points Change of Pain Evaluation Scale
Self-assess pain using a visual analog scale (VAS), which is a straight line 10 cm in length, with 0 cm on the left representing no pain and 10 cm on the right representing extreme pain. Explain to the subjects that the pain intensity increases from left to right. Ask the subjects to mark the point on the line that corresponds to their pain level, and then record the distance in centimeters from the 0 cm mark. Record the points that the subjects wrote.
Time frame: baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Points Change of Pain Evaluation Scale | Normal walk, Left Baseline | 1.49 score on a scale | Standard Deviation 1.19 |
| Control Group | Points Change of Pain Evaluation Scale | Normal walk, Left Week 6 | 1.15 score on a scale | Standard Deviation 1.13 |
| Control Group | Points Change of Pain Evaluation Scale | Normal walk, Left Week 12 | 0.85 score on a scale | Standard Deviation 1.05 |
| Control Group | Points Change of Pain Evaluation Scale | Normal walk, Right Baseline | 1.49 score on a scale | Standard Deviation 1.19 |
| Control Group | Points Change of Pain Evaluation Scale | Normal walk, Right Week 6 | 1.29 score on a scale | Standard Deviation 1.47 |
| Control Group | Points Change of Pain Evaluation Scale | Normal walk, Right Week 12 | 0.84 score on a scale | Standard Deviation 1 |
| Control Group | Points Change of Pain Evaluation Scale | Stand up/squat down, Left Baseline | 2.83 score on a scale | Standard Deviation 1.68 |
| Control Group | Points Change of Pain Evaluation Scale | Stand up/squat down, Left Week 6 | 1.81 score on a scale | Standard Deviation 1.39 |
| Control Group | Points Change of Pain Evaluation Scale | Stand up/squat down, Left Week 12 | 1.29 score on a scale | Standard Deviation 1.29 |
| Control Group | Points Change of Pain Evaluation Scale | Stand up/squat down, Right Baseline | 2.83 score on a scale | Standard Deviation 1.68 |
| Control Group | Points Change of Pain Evaluation Scale | Stand up/squat down, Right Week 6 | 2.04 score on a scale | Standard Deviation 1.72 |
| Control Group | Points Change of Pain Evaluation Scale | Stand up/squat down, Right Week 12 | 1.51 score on a scale | Standard Deviation 1.35 |
| Control Group | Points Change of Pain Evaluation Scale | Bend to biggest angle, Left Baseline | 2.53 score on a scale | Standard Deviation 2.22 |
| Control Group | Points Change of Pain Evaluation Scale | Bend to biggest angle, Left Week 6 | 1.54 score on a scale | Standard Deviation 1.5 |
| Control Group | Points Change of Pain Evaluation Scale | Bend to biggest angle, Left Week 12 | 0.98 score on a scale | Standard Deviation 1.12 |
| Control Group | Points Change of Pain Evaluation Scale | Bend to biggest angle, Right Baseline | 2.53 score on a scale | Standard Deviation 2.22 |
| Control Group | Points Change of Pain Evaluation Scale | Bend to biggest angle, Right Week 6 | 1.54 score on a scale | Standard Deviation 1.5 |
| Control Group | Points Change of Pain Evaluation Scale | Bend to biggest angle, Right Week 12 | 0.98 score on a scale | Standard Deviation 1.12 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Bend to biggest angle, Left Week 6 | 1.23 score on a scale | Standard Deviation 1.47 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Normal walk, Left Baseline | 1.15 score on a scale | Standard Deviation 0.94 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Stand up/squat down, Right Baseline | 2.53 score on a scale | Standard Deviation 1.61 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Normal walk, Left Week 6 | 1.14 score on a scale | Standard Deviation 1.08 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Bend to biggest angle, Right Week 12 | 0.52 score on a scale | Standard Deviation 0.53 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Normal walk, Left Week 12 | 0.50 score on a scale | Standard Deviation 0.75 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Stand up/squat down, Right Week 6 | 1.78 score on a scale | Standard Deviation 1.42 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Normal walk, Right Baseline | 1.15 score on a scale | Standard Deviation 0.94 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Bend to biggest angle, Left Week 12 | 0.52 score on a scale | Standard Deviation 0.53 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Normal walk, Right Week 6 | 1.31 score on a scale | Standard Deviation 1.1 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Stand up/squat down, Right Week 12 | 1.20 score on a scale | Standard Deviation 1.09 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Normal walk, Right Week 12 | 0.63 score on a scale | Standard Deviation 0.74 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Bend to biggest angle, Right Week 6 | 1.23 score on a scale | Standard Deviation 1.47 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Stand up/squat down, Left Baseline | 2.53 score on a scale | Standard Deviation 1.61 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Bend to biggest angle, Left Baseline | 1.50 score on a scale | Standard Deviation 1.18 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Stand up/squat down, Left Week 6 | 1.67 score on a scale | Standard Deviation 1.22 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Bend to biggest angle, Right Baseline | 1.50 score on a scale | Standard Deviation 1.18 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Pain Evaluation Scale | Stand up/squat down, Left Week 12 | 0.97 score on a scale | Standard Deviation 0.85 |
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Normal walk, Left baseline, week 6, and week 12.p-value: 0.478ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Normal walk, Right baseline, week 6, and week 12.p-value: 0.612ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Stand up/squat down, Left baseline, week 6, and week 12.p-value: 0.534ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Stand up/squat down, Right baseline, week 6, and week 12.p-value: 0.538ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Bend to biggest angle, Left baseline, week 6, and week 12.p-value: 0.195ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Bend to biggest angle, Right baseline, week 6, and week 12.p-value: 0.232ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Normal walk, Left.p-value: 0.369ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Normal walk, Right.p-value: 0.593ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stand up/squat down, Left.p-value: 0.918ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stand up/squat down, Right.p-value: 0.99ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Bend to biggest angle, Left.p-value: 0.263ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Bend to biggest angle, Right.p-value: 0.235ANOVA
Primary
Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a widely used questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, and the total score was 96 points (Minimum: 0 points; Maximum: 96 points). The question content was divided into three parts: Pain (20 points), Stiffness (8 points), and Physical function (68 points). The higher score meant worse knee joint function. Record the points that the subjects got.
Time frame: baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pain Week 6 | 4.47 score on a scale | Standard Deviation 2.53 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Stiffness Week 12 | 1.27 score on a scale | Standard Deviation 1.22 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Stiffness Baseline | 1.93 score on a scale | Standard Deviation 1.39 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Physical function Baseline | 10.00 score on a scale | Standard Deviation 8.64 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pain Week 12 | 4.07 score on a scale | Standard Deviation 2.99 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Physical function Week 6 | 6.47 score on a scale | Standard Deviation 6.62 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Stiffness Week 6 | 1.13 score on a scale | Standard Deviation 0.92 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Physical function Week 12 | 6.73 score on a scale | Standard Deviation 8.56 |
| Control Group | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pain Baeline | 5.73 score on a scale | Standard Deviation 2.99 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Physical function Week 12 | 4.87 score on a scale | Standard Deviation 4.98 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pain Baeline | 5.27 score on a scale | Standard Deviation 2.52 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pain Week 6 | 4.73 score on a scale | Standard Deviation 2.94 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Pain Week 12 | 3.67 score on a scale | Standard Deviation 2.72 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Stiffness Baseline | 1.60 score on a scale | Standard Deviation 0.99 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Stiffness Week 6 | 1.53 score on a scale | Standard Deviation 0.92 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Stiffness Week 12 | 1.33 score on a scale | Standard Deviation 0.9 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Physical function Baseline | 9.00 score on a scale | Standard Deviation 6.28 |
| Test Group (UCII, Glucosamine, and Curcumin) | Points Change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Physical function Week 6 | 6.53 score on a scale | Standard Deviation 4.76 |
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Pain on baseline, week 6, and week 12.p-value: 0.823ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Stiffness on baseline, week 6, and week 12.p-value: 0.895ANOVA
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of Physical function on baseline, week 6, and week 12.p-value: 0.682ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Pain.p-value: 0.303ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stiffness.p-value: 0.148ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Physical function.p-value: 0.283ANOVA
Primary
The Concentration of Serum Inflammatory Factors
The concentration of interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and tumor necrosis factor alpha (TNF-α) in serum.
Time frame: baseline, week 6, week 12
Population: Data were not reported because the value was lower than limit of detection.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control Group | The Concentration of Serum Inflammatory Factors | IL-6 Week 6 | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | IL-1β Week 12 | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | IL-1β Baseline | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | TNF-α Baseline | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | IL-6 Week 12 | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | TNF-α Week 6 | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | IL-1β Week 6 | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | TNF-α Week 12 | NA unit of measure: concentration (pg/mL) |
| Control Group | The Concentration of Serum Inflammatory Factors | IL-6 Baseline | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | TNF-α Week 12 | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | IL-6 Baseline | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | IL-6 Week 6 | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | IL-6 Week 12 | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | IL-1β Baseline | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | IL-1β Week 6 | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | IL-1β Week 12 | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | TNF-α Baseline | NA unit of measure: concentration (pg/mL) |
| Test Group (UCII, Glucosamine, and Curcumin) | The Concentration of Serum Inflammatory Factors | TNF-α Week 6 | NA unit of measure: concentration (pg/mL) |
Primary
Time Change of Up-and-go Test
Timed up-and-go test (TUG) was a professional physical therapist marked a distance of 3 meters on the ground and placed an armless chair at one end. The subject sat on the chair with a straight back, and the time was measured from when the subject stood up and walked to the 3-meter mark at their usual speed, turned around, walked back, and sat down again. Shorter time spent indicates better knee function. Record the time that the subjects spent.
Time frame: baseline, week 6, week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Time Change of Up-and-go Test | Baseline | 9.96 unit of measure: seconds | Standard Deviation 1.47 |
| Control Group | Time Change of Up-and-go Test | Week 6 | 8.75 unit of measure: seconds | Standard Deviation 0.68 |
| Control Group | Time Change of Up-and-go Test | Week 12 | 8.64 unit of measure: seconds | Standard Deviation 0.73 |
| Test Group (UCII, Glucosamine, and Curcumin) | Time Change of Up-and-go Test | Baseline | 9.3 unit of measure: seconds | Standard Deviation 0.98 |
| Test Group (UCII, Glucosamine, and Curcumin) | Time Change of Up-and-go Test | Week 6 | 8.83 unit of measure: seconds | Standard Deviation 0.71 |
| Test Group (UCII, Glucosamine, and Curcumin) | Time Change of Up-and-go Test | Week 12 | 8.55 unit of measure: seconds | Standard Deviation 0.76 |
Comparison: This analysis examined the overall (main) effect of treatment-comparing Control and Test groups across the three time points (baseline, week 6, and week 12) Comparison groups: Control and Test group of up-and-go test on baseline, week 6, and week 12.p-value: 0.399ANOVA
Comparison: It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of timed up-and-go test.p-value: 0.106ANOVA