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This research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Control group use 42 mg UCII. |
|
| Test group (UCII, glucosamine, and curcumin) | Experimental | Test group use 42 mg UCII, 460 mg glucosamine and 380 mg curcumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCII, glucosamine and curcumin | Dietary Supplement | compound capsules twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, week 6, week 12 |
| 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. | baseline, week 6, week 12 |
| 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 | baseline, week 6, week 12 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei medical university | Taipei | Taiwan |
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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 were recruited from social media between August 2024 and September 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control group use 42 mg UCII. Placebo: Placebo capsules twice daily. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control group use 42 mg UCII. Placebo: Placebo capsules twice daily. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, week 6, week 12 |
|
No applicable
Death, serious adverse events, and others (non-serious adverse events) were not assessed for the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Control group use 42 mg UCII. Placebo: Placebo capsules twice daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| YiWen Chien, PhD | Taipei medical university | 02-2736-1661 | 6556 | ychien@tmu.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2025 | Jan 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005944 | Glucosamine |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D006595 | Hexosamines |
| D000606 | Amino Sugars |
| D002241 | Carbohydrates |
| D036381 | Diarylheptanoids |
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| Placebo | Dietary Supplement | Placebo capsules twice daily. |
|
| baseline, week 6, week 12 |
| 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. | baseline, week 6, week 12 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Test group use 42 mg UCII, 460 mg glucosamine and 380 mg curcumin
UCII, glucosamine and curcumin: compound capsules twice daily.
|
|
|
| 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. | Posted | Mean | Standard Deviation | unit of measure: seconds | baseline, week 6, week 12 |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | unit of measure: Degrees | baseline, week 6, week 12 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, week 6, week 12 |
|
|
|
|
| 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. | Data were not reported because the value was lower than limit of detection. | Posted | Mean | Standard Deviation | unit of measure: concentration (pg/mL) | baseline, week 6, week 12 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006536 |
| Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| Week 12 |
|
| 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. | ANOVA | 0.106 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| AROM, Left Week 12 |
|
| AROM, Right Baseline |
|
| AROM, Right Week 6 |
|
| AROM, Right Week 12 |
|
| PROM, Left Baseline |
|
| PROM, Left Week 6 |
|
| PROM, Left Week 12 |
|
| PROM, Right Baseline |
|
| PROM, Right Week 6 |
|
| PROM, Right Week 12 |
|
|
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. |
| ANOVA |
| 0.724 |
It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05. |
| Superiority |
| 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. | ANOVA | 0.414 | It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05. | Superiority |
| 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. | ANOVA | 0.563 | It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of AROM, Left. | ANOVA | 0.110 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of AROM, Right. | ANOVA | 0.245 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of PROM, Left. | ANOVA | 0.113 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of PROM, Right. | ANOVA | 0.395 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| Pain Week 12 |
|
| Stiffness Baseline |
|
| Stiffness Week 6 |
|
| Stiffness Week 12 |
|
| Physical function Baseline |
|
| Physical function Week 6 |
|
| Physical function Week 12 |
|
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. |
| ANOVA |
| 0.895 |
It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05. |
| Superiority |
| 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. | ANOVA | 0.682 | It calculated the p value of two treatment (Control group and Test group). The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Pain. | ANOVA | 0.303 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Stiffness. | ANOVA | 0.148 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| It calculated the interaction between 2 groups (Control group and Test group) X 3 time points (Baseline, week 6, week 12) of Physical function. | ANOVA | 0.283 | It calculated the p value of the interaction between 2 groups X 3 time points. The threshold of statistical significance was p = 0.05. | Superiority |
| IL-6 Week 12 |
|
| IL-1β Baseline |
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| IL-1β Week 6 |
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| IL-1β Week 12 |
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| TNF-α Baseline |
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| TNF-α Week 6 |
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| TNF-α Week 12 |
|