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Table 1 Baseline demographics and clinical characteristics of included patients

From: Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial

Variable

Placebo N = 17

AP N = 20

Age (years)

 Mean ± SD

58.1 ± 7.0

59.4 ± 5.7

 Median (range)

57 (50–73)

58.5 (51–70)

Female sex, n (%)

9 (53)

15 (75)

Primary progressive, n (%)

10 (59)

10 (50)

Clinical progression in the year prior to enrolment, n (%)

10 (59)

16 (80)

Disease duration

 Mean ± SD

14.2 ± 9.6

14.9 ± 11.5

 Median (range)

11 (4–34)

11.5 (5–45)

EDSS

 Median

6

6

 Range

2.5–7.0

3.5–7.0

9-Hole Peg Test (seconds)

 Median

23.15

20.86

 Range

13.95–32.7

14.3–30.1

Timed 25-ft walk test (seconds)

 Median

13.47

10.48

 Range

5.6–89

7.6–34.6

 Not able to complete, n (%)

1 (5.6)

4 (20)

Paced Auditory Serial Addition Test z-score

 Mean + SD

−1.96 ± 1.48

−1.63 ± 1.57

Multiple Sclerosis Functional Composite

 Mean ± SD

−0.17 ± 0.59

0.20 ± 0.35

 Median

−0.14

− 0.01

 Range

−2.23

−0.88

Symbol Digit Modalities Test z-score

 Mean ± SD

−0.88 ± 0.99

0.03 ± 0.66

Retinal nerve fibre layer thickness (μm)

 Mean ± SD

89.97 ± 15.49

90.28 ± 12.86

MRI activity (gadolinium-enhancing lesions), n (%)

0 (0)

0 (0)

Normalized brain volume (mm3 ± SD)

1,288,183 ± 86,721

1,311,701 ± 93,647

Normalized white matter volume (mm3 ± SD)

662,732 ± 51,640

665,999 ± 48,708

Normalized grey matter volume (mm3 ± SD)

625,451 ± 41,492

645,702 ± 49,755

Brain parenchymal fraction ± SD

0.95 ± 0.02

0.95 ± 0.02

  1. SD Standard deviation. Brain Parenchymal Fraction = Normalized Brain Volume/Total Intracranial Volume. No statistically significant differences were observed between the baseline characteristics, except for the Multiple Sclerosis Functional Composite Wilcoxon rank-sum test (p = 0.024). Fisher’s exact test: sex, p = 0.16; phenotype, p = 0.59; baseline progression, p = 0.25