Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-04-13 @ 6:25 PM
Study NCT ID:
NCT06581094
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2024-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of UC-II, Glucosamine and Curcumin Supplementation on Knee Pain and Inflammation.
Sponsor:
Organization:
Raw JSON
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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.\n\nRecord the points that the subjects wrote.'}, {'measure': 'Time change of up-and-go test', 'timeFrame': 'baseline, week 6, week 12', 'description': '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.\n\nRecord the time that the subjects spent.'}, {'measure': 'Angle change of range of motion (ROM)', 'timeFrame': 'baseline, week 6, week 12', 'description': '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.\n\nRecord the angle that the physical therapist measured.'}, {'measure': 'Points change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)', 'timeFrame': 'baseline, week 6, week 12', 'description': 'A widely used questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.\n\nRecord the points that the subjects got.'}, {'measure': 'The concentration of serum inflammatory factors', 'timeFrame': 'baseline, week 6, week 12', 'description': 'The concentration of interleukin-6 (IL-6), interleukin-1 beta (IL-1β), and tumor necrosis factor alpha (TNF-α) in serum.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-denatured type II collagen', 'Glucosamine', 'Curcumin', 'Knee Pain'], 'conditions': ['Inflammation', 'Knee Pain Chronic']}, 'descriptionModule': {'briefSummary': 'This research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.', 'detailedDescription': "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.\n\nOnce 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.\n\nThere 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Knee plain\n\nExclusion Criteria:\n\n* Severe diseases of the heart, liver, kidneys, endocrine system, and other organs\n* Long-term use of medication\n* Infection, hypertension, diabetes, cerebrovascular disease, heart disease, liver disease, kidney disease, gastrointestinal disease\n* Allergy to this product'}, 'identificationModule': {'nctId': 'NCT06581094', 'briefTitle': 'Effects of UC-II, Glucosamine and Curcumin Supplementation on Knee Pain and Inflammation.', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'Effects of UC-II, Glucosamine and Curcumin Supplementation on Knee Pain and Inflammation: A Randomized, Single-blind, Placebo-controlled Parallel-group Trial', 'orgStudyIdInfo': {'id': 'N202406039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group use 42 mg UCII.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Test group (UCII, glucosamine, and curcumin)', 'description': 'Test group use 42 mg UCII, 460 mg glucosamine and 380 mg curcumin', 'interventionNames': ['Dietary Supplement: UCII, glucosamine and curcumin']}], 'interventions': [{'name': 'UCII, glucosamine and curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'compound capsules twice daily.', 'armGroupLabels': ['Test group (UCII, glucosamine, and curcumin)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo capsules twice daily.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'YiWen Chien, PhD', 'role': 'CONTACT', 'email': 'ychien@tmu.edu.tw', 'phone': '02-2736-1661', 'phoneExt': '6556'}], 'facility': 'Taipei medical university', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-05', 'type': 'RELEASE'}, {'date': '2025-03-25', 'type': 'RESET'}, {'date': '2025-05-04', 'type': 'RELEASE'}, {'date': '2025-05-20', 'type': 'RESET'}, {'date': '2025-11-13', 'type': 'RELEASE'}, {'date': '2025-11-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Taipei Medical University'}}}}