Research Article
Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial
Table 1
Baseline characteristics between experimental group and control group.
| | Variable | TNG (n = 431) | PC (n = 144) | value |
| | Gender, n (%) | | | 1.0000 | | Male (%) | 94 (21.81%) | 31 (21.53%) | | | Female (%) | 337 (78.19%) | 113 (78.47%) | | | Age (years) | 55.44 ± 8.16 | 54.44 ± 8.20 | 0.2035 | | Height (cm) | 162.83 ± 6.56 | 162.43 ± 7.06 | 0.5323 | | Weight (kg) | 61.73 ± 8.13 | 60.89 ± 8.77 | 0.2906 | | Heart rate (beats/min) | 71.69 ± 7.99 | 71.26 ± 8.52 | 0.5787 | | Respiratory rate (beats/min) | 18.52 ± 1.55 | 18.68 ± 1.87 | 0.3677 | | Systolic BP (mmHg) | 123.23 ± 9.29 | 122.58 ± 10.23 | 0.4785 | | Diastolic BP (mmHg) | 77.63 ± 6.70 | 76.95 ± 7.47 | 0.3370 | | Duration of KOA (months) | 8.00 ± 21.00 | 6.00 ± 14.00 | 0.530 | | Location of the disease, n (%) | | | 0.0129 | | Left knee | 207 (48.03%) | 55 (38.19%) | | | Right knee | 223 (51.74%) | 86 (59.72%) | | | Both knees | 1 (0.23%) | 3 (2.08%) | | | Baseline WOMAC, mean ± SD | | | | | Pain score | 183.61 ± 64.86 | 177.36 ± 66.92 | 0.3215 | | Stiffness score | 47.87 ± 31.53 | 46.76 ± 32.48 | 0.7165 | | Function score | 579.88 ± 195.62 | 555.01 ± 202.97 | 0.1913 | | Total score | 811.35 ± 272.16 | 779.13 ± 281.19 | 0.2230 | | KL classification, n (%) | | | 0.738 | | Grade 0 | 18 (4.18%) | 13 (9.03%) | | | Grade 1 | 116 (26.91%) | 32 (22.22%) | | | Grade 2 | 246 (57.08%) | 82 (56.94%) | | | Grade 3 | 51 (11.83%) | 17 (11.81%) | | | History of treatment, n (%) | | | 1.0000 | | No | 430 (99.77%) | 144 (100.00%) | | | Yes | 1 (0.23%) | 0 (0.00%) | | | Other disease: no. of patients (%) | | | 0.7018 | | No | 403 (93.50%) | 133 (92.36%) | | | Yes | 28 (6.50%) | 11 (7.64%) | | | History of drug allergy: no. of patients (%) | | | 0.6977 | | No | 425 (98.61%) | 141 (97.92%) | | | Yes | 6 (1.39%) | 3 (2.08%) | |
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Plus-minus values are means ± SD unless otherwise noted. TNG = Tongning Gel; PC = placebo-controlled. WOMAC = the Western Ontario and McMaster Universities Arthritis Index. KL classification = Kellgren–Lawrence classification.
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