Sustained Release Formulation of Primaquine for Prevention of Relapse of Plasmodium vivax Malaria: A Randomized, Double-Blind, Comparative, Multicentric Study
Table 1
Demographic and baseline disease characteristics of patients.
Parameters
P 15 mg ()
PSR 15 mg ()
PSR 30 mg ()
Total ()
value
Male
99 (82.5)
99 (83.9)
98 (81.7)
296 (82.7)
0.923
Age (years)
31 (23)
28 (21)
28 (18)
29 (20)
0.197
Weight (kg) Min–max
56.77 ± 9.07
56.41 ± 9.36
57.13 ± 8.84
56.77 ± 9.07
0.760
40–86
32–92
40–86
32–92
Body temperature (°C)
38.50 ± 0.84
38.5 ± 0.93
38.49 ± 0.76
38.5 ± 0.84
0.988
Respiration rate (breaths/min)
17.85 ± 3.74
17.98 ± 3.78
17.98 ± 3.79
17.95 ± 3.76
0.943
Parasite density (/µL) (Min–Max)
6564.9 ± 12614.9
6168.7 ± 15128.1
6145.9 ± 13508.3
6293.9 ± 13744.5
0.969
1000–100000
1000–141300
800–121100
800–141300
Patients with parasites
5000/µL
90 (75.0)
92 (78.0)
95 (79.2)
277 (77.4)
0.986
5000 and <15000/µL
16 (13.3)
15 (12.7)
14 (11.7)
45 (12.6)
15000 and <30000/µL
10 (8.3)
8 (6.8)
7 (5.8)
25 (6.9)
30000/µL
4 (3.3)
3 (2.5)
4 (3.3)
11 (3.1)
Signs and symptoms
Fever
120 (100.0)
118 (100.0)
119 (99.17)
357 (99.7)
0.664
Chills
118 (98.33)
117 (99.15)
118 (98.33)
353 (98.5)
0.999
Headache
116 (96.67)
113 (95.76)
110 (91.67)
338 (94.6)
0.207
Nausea
99 (82.5)
88 (74.58)
89 (74.17)
276 (77.0)
0.209
Malaise
89 (74.17)
81 (68.64)
89 (74.17)
258 (72.2)
0.576
Vomiting
59 (49.17)
57 (48.31)
58 (48.33)
174 (48.4)
0.981
Myalgia
57 (47.5)
59 (50.0)
57 (47.5)
173 (48.3)
0.929
Anorexia
59 (49.17)
52 (44.07)
57 (47.5)
167 (46.7)
0.729
Arthralgia
11 (9.2)
17 (14.4)
14 (11.8)
42 (11.7)
0.461
Abdominal cramps
9 (7.5)
9 (7.6)
8 (6.7)
26 (7.3)
0.999
Diarrhoea
6 (5.0)
6 (5.1)
5 (4.2)
17 (4.7)
0.953
P 15 mg: conventional primaquine 15 mg, PSR 15 mg: primaquine sustained release 15 mg, and PSR 30 mg: primaquine sustained release 30 mg. Two patients were excluded from the total number of patients enrolled to receive chloroquine therapy. b indicates value shown as (%), Chi-square test used for comparison. c indicates value shown as median (IQR), Kruskal-Wallis test used for the comparison. d indicates value shown as mean ± SD, one way ANOVA used for comparison.
