A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy and Safety of a Novel Low-Dose Turmeric Extract Formulation in Healthy Adults with Chronic Knee Pain

Figures & data

Figure 1 Subject flow diagram.

Table 1 Baseline Demographic Characteristics

	WDTE60N (n = 53)	Placebo (n = 53)
Age (year)	36.6 ± 10	37.7 ± 9.3
Gender
Men	24	30
Women	29	23
Body mass index (kg/m^2)	23.7 ± 2.8	23.6 ± 2.4

Figure 2 Proportion of subjects with reduction in VAS at day 90.

Table 2 Efficacy Endpoints

	WDTE60N (n = 49)		Placebo (n = 47)		p-value
	Mean ± SD	Median (IQR)	Mean ± SD	Median (IQR)
Visual analogue scale after 80-m fast-paced walk test
Baseline	5.4 ± 0.9	5 (5, 6)	5.4 ± 0.8	5 (5, 6)
Day 45	4.4 ± 0.8	4 (4, 5)	4.9 ± 0.6	5 (5, 5)
Day 90	3.8 ± 0.8	4 (3, 4)	4.8 ± 0.6	5 (4.3, 5)
Change from B to D45	−1.5 ± 0.4	−1 (−1, −1)	−0.4 ± 0.6	0 (−1, 0)	< 0.0001*
Change from B to D90	−1.5 ± 0.7	−2 (−2, −1)	−0.6 ± 0.8	0 (−1, 0)	< 0.0001*
80 m- fast-paced walk test (s)
Baseline	70.3 ± 23.9	60.1 (59.1, 60.5)	69.2 ± 23.4	60.08 (57.7, 60.3)
Day 45	65.2 ± 18.8	60.0 (58.9, 60.1)	62.9 ± 15.2	60.04 (57.8, 60.2)
Day 90	59.3 ± 9.5	59.8 (57.3, 60.1)	62.4 ± 15.4	60.0 (57.4, 60.1)
Change from B to D45	−5.0 ± 16.5	−0.09 (−0.3, −0.04)	−6.3 ± 18.6	0.0 (−0.07, 0.07)	0.0002*
Change from B to D90	−11.0 ± 26.1	−0.2 (−2, −0.06)	−6.8 ± 23.3	0 (−0.2, 0.2)	0.0011*
9-step stair climb test (s)
Baseline	49.2 ± 40.9	60.2 (10.8, 60.5)	44.8 ± 39.2	60.2 (10.6, 60.5)
Day 45	40.2 ± 29.7	60.0 (10.6, 60.2)	39.9 ± 32.1	60.1 (10.8, 60.2)
Day 90	36.9 ± 24.3	52.0 (10.5, 60.1)	37.0 ± 27.6	52 (10.8, 60.1)
Change from B to D45	−8.9 ± 21.0	−0.1 (−0.4, −0.07)	−4.9 ± 21.0	0.04 (−0.07, 0.09)	< 0.0001*
Change from B to D90	−12.3 ± 24.2	0.2 (−0.8, −0.1)	−7.8 ± 24.2	0.04 (−0.2, 0.1)	< 0.0001*
Primary knee flexion (degree)
Baseline	134.2 ± 0.9	134 (134, 135)	134.4 ± 0.9	134 (134, 135)
Day 45	134.1 ± 0.6	134 (134, 134)	134.3 ± 0.8	134 (134, 135)
Day 90	134.0 ± 0.6	134 (134, 134)	134.3 ± 0.7	134 (134, 134)
Change from B to D45	−0.1 ± 0.7	0 (0, 0)	−0.0 ± 0.5	0 (0, 0)
Change from B to D90	−0.2 ± 0.6	0 (0, 0)	−0.1 ± 0.8	0 (0, 0)	0.3657

Note: *p-value less than 0.05 (p ≤ 0.05) is statistically significant.

Abbreviations: B to D, baseline to day; IQR, interquartile range.

Table 3 Biochemical and Inflammatory Markers

	WDTE60N (n = 49)		Placebo (n = 47)		p-value*
	Mean ± SD	Median (IQR)	Mean ± SD	Median (IQR)
C-reactive protein (mg/dL)
Baseline	5.3 ± 14.0	1.7 (0.9, 4.8)	3.0 ± 3.6	1.6 (0.8, 3.4)
Day 90	2.6 ± 2.6	1.6 (0.9, 3.4)	9.5 ± 26.8	1.9 (1, 4)
Change from B to D90	−2.7 ± 14.5	−0.2 (−1.5, 1.1)	6.5 ± 26.7	0.0 (−0.8, 1.4)	0.2868
p-value**	0.2327		0.2676
Interleukin 6 (pg/mL)
Baseline	21.1 ± 31.3	8.1 (0.07, 29.7)	20.5 ± 36.3	3.3 (0.07, 18.4)
Day 90	30.5 ± 52.6	4.1 (0.7, 26.7)	26.8 ± 40.2	8.3 (1, 31.7)
Change from B to D90	9.4 ± 62.7	0.5 (−19, 12.8)	6.3 ± 36.6	3.1 (−0.79, 22.6)	0.1699
p-value**	0.4641		0.0188
Tumor necrosis factor-α (pg/mL)
Baseline	30.4 ± 52.5	2.6 (0.2, 48.8)	31.6 ± 60.6	0.7 (0.1, 34.4)
Day 90	14.9 ± 45.1	0.7 (0.7, 0.7)	22.4 ± 32.6	0.7 (0.7, 30.7)
Change from B to D90	−15.5 ± 67.1	−0.2 (−24.9, 0.6)	−9.3 ± 67.3	0.5 (−20.6, 12.4)	0.0927
p-value**	0.0054		0.4522
Matrix metalloproteinase-3 (ng/mL)
Baseline	20.9 ± 15.4	19.7 (6.6, 35.0)	18.9 ± 16.6	12.5 (5.5, 34.2)
Day 90	14.1 ± 9.4	12.5 (6.6, 19.6)	15.9 ± 9.7	13 (7.7, 23.5)
Change from B to D90	−6.8 ± 14.9	−7 (−15.7, 2.5)	−3.0 ± 14	−0.4 (−9.4, 5.7)	0.1387
p-value**	0.0017		0.1335

Notes: *p-value from the Mann–Whitney U-test comparing the difference between placebo versus WDTE60N; **p-value from Wilcoxon signed-rank test comparing levels at baseline to day 90.

Abbreviations: B to D, baseline to day; IQR, interquartile range.

Table 4 Summary of Adverse Events

Adverse Events	WDTE60N (n = 53)	Placebo (n = 53)
Headache	1 (1.89%)	0
Nausea	1 (1.89%)	0
Diarrhea	0	1 (1.89%)