NCT06581094

Brief Summary

This research evaluated the effects of UCII, glucosamine and curcumin supplementation on knee pain and inflammation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 7, 2026

Completed
Last Updated

January 7, 2026

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

August 29, 2024

Results QC Date

March 5, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

Non-denatured type II collagenGlucosamineCurcuminKnee Pain

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

Study Arms (2)

Control group

PLACEBO COMPARATOR

Control group use 42 mg UCII.

Dietary Supplement: Placebo

Test group (UCII, glucosamine, and curcumin)

EXPERIMENTAL

Test group use 42 mg UCII, 460 mg glucosamine and 380 mg curcumin

Dietary Supplement: UCII, glucosamine and curcumin

Interventions

compound capsules twice daily.

Test group (UCII, glucosamine, and curcumin)
PlaceboDIETARY_SUPPLEMENT

Placebo capsules twice daily.

Control group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee plain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei medical university

Taipei, Taiwan

Location

MeSH Terms

Conditions

Inflammation

Interventions

GlucosamineCurcumin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosaminesAmino SugarsCarbohydratesDiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Results Point of Contact

Title
YiWen Chien, PhD
Organization
Taipei medical university

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 3, 2024

Study Start

August 20, 2024

Primary Completion

November 14, 2024

Study Completion

December 3, 2024

Last Updated

January 7, 2026

Results First Posted

January 7, 2026

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations