Effects of UC-II, Glucosamine and Curcumin Supplementation on Knee Pain and Inflammation: A Randomized, Single-blind, Placebo-controlled Parallel-group Trial
Phase: NA
Conditions: Inflammation, Knee Pain Chronic
Sponsor: Taipei Medical University

 
 
 
Official title:  
Effects of UC-II, Glucosamine and Curcumin 
Supplementation on Knee Pain and 
Inflammation: A Randomized, Single-blind, 
Placebo-controlled Parallel-group Trial 
 
 
 
 
NCT number: 06581094 
 
 
 
 
 
Document date: 2025/3/4 

Study protocol 
I. 
Study design 
Study type: Interventional 
Primary purpose: Treatment 
Interventional study model: Parallel assignment 
Number of Arms: 2 
Allocation: Randomized 
Enrollment: 32 
 
II. Arms and interventions 
Arms 
Assigned interventions 
⚫ 
Placebo Comparator: Control group 
⚫ 
Control group use 42 mg UCII. 
⚫ 
Dietary Supplement: Placebo 
⚫ 
Placebo capsules twice daily. 
⚫ 
Experimental: Test group (UCII, 
glucosamine, and curcumin) 
⚫ 
Test group use 42 mg UCII, 460 mg 
glucosamine and 380 mg curcumin 
⚫ 
Dietary Supplement: UCII, 
glucosamine and curcumin 
⚫ 
Compound capsules twice daily. 
 
III. Outcome measures 
1. 
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. 
2. 
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. 
3. 
Angle 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. 
4. 
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, 
including pain, stiffness, and physical functioning of the joints. The higher 
score meant worse knee joint function. Record the points that the subjects 
got. 
5. 
The Concentration of Serum Inflammatory Factors 
Using commercial kits to test the concentration of interleukin-6 (IL-6), 
interleukin-1 beta (IL-1β), and tumor necrosis factor alpha (TNF-α) in 
serum. 
 
Statistical analysis plan 
Values were displayed as mean ± SD. Statistical Product and Service Solutions 
software (v.18) was used for data analysis. The paired t test was used to compare the 
basic data during the same period. Repeated measured ANOVA was used to compare 
the statistical differences between the other groups (UCII structural group and 
turmeric compound product) * (weeks 0, 6, and 12).