A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Duliang Soft Capsule in Patients with Chronic Daily Headache

Table 1

Baseline characteristics of patients receiving Duliang soft capsules (DSC) and placebo (intent-to-treat population).

Characteristics	DSC ()	Placebo ()	values
Age (years)	43.64 ± 11.38	44.56 ± 11.36	0.46
Height (cm)	162.12 ± 7.17	163.93 ± 7.11	0.05
Weight (kg)	60.61 ± 11.06	62.05 ± 15	0.28
Body temperature (°C)	36.57 ± 0.27	36.61 ± 0.27	0.18
Pulsation (bpm)	72.78 ± 7.47	74.17 ± 8.43	0.10
Systolic blood pressure (mmHg)	120.75 ± 10.32	120.46 ± 11.8	0.81
Diastolic blood pressure (mmHg)	76.43 ± 7.62	74.98 ± 9.05	0.10
Breathing (bpm)	18.44 ± 1.5	18.39 ± 1.4	0.74
BMI (kg/m^2)	23.03 ± 3.74	23 ± 5.07	0.95
VAS score, (%)
Mild (0–3)	75 (22.19%)	33 (29.73%)	0.69
Moderate (4–6)	146 (43.2%)	37 (33.33%)	0.08
Severe (7–10)	117 (34.62%)	41 (36.94%)	0.76
Site of headache, (%)
Unilateral	102 (30.18%)	40 (36.04%)	0.06
Bilateral	195 (57.69%)	59 (53.15%)	0.19
Others	41 (12.13%)	12 (10.81%)	0.45
Use of analgesic, (%)			0.34
Yes	333 (98.52%)	111 (100%)
No	5 (1.48%)	0 (0)
Headache duration per day, (%)			0.88
≥4 h	235 (69.53%)	78 (70.27%)
<4 h	103 (30.47%)	33 (29.73%)
Headache type at screening
Migraine	72 (21.30%)	23 (20.72%)	0.79
Tension-type headache	84 (24.85%)	29 (26.13%)	0.60
Both migraine and TTH	149 (44.08%)	48 (43.24%)	0.75
Others	33 (9.76%)	11 (9.91%)	0.93