Table 1.
The characteristics of registered TCM trials on COVID-19 (as of July 31, 2020).
| Items | Details | Number of trials | Percent (%) |
|---|---|---|---|
| Study type | Randomized controlled trials | 94 | 58.4% |
| Non-randomized controlled clinical trials | 25 | 15.5% | |
| Single-arm trials | 18 | 11.2% | |
| Real world clinical studies | 10 | 6.2% | |
| Retrospective studies | 10 | 6.2% | |
| Cross-sectional studies | 4 | 2.5% | |
| Objective | Preventive trial | 12 | 7.5% |
| Therapeutic trial | 114 | 70.8% | |
| Rehabilitation trial | 23 | 14.3% | |
| Study on TCM syndrome epidemiology | 4 | 2.5% | |
| Multi-objective | 8 | 5.0% | |
| Sample size | ≤100 | 63 | 39.1% |
| 101–300 | 65 | 40.4% | |
| 301–500 | 16 | 9.9% | |
| 501–1000 | 11 | 6.8% | |
| >1000 | 6 | 3.7% | |
| Participants (in 114 therapeutic trials) | Suspected cases*1 | 10 | 8.8% |
| Mild or moderate patients | 55 | 48.2% | |
| Severe patients | 32 | 28.1% | |
| Critical patients | 3 | 2.6% | |
| Confirmed patients (no details on severity) | 39 | 34.2% | |
| TCM Interventions | Chinese patent medicine | 40 | 24.8% |
| Decoction or granules of fixed formulae | 50 | 31.1% | |
| Decoction or granules based on TCM syndrome differentiation | 17 | 10.6% | |
| Chinese herbal-derived injections | 13 | 8.1% | |
| TCM exercises (Qigong/Daoyin/Liuzijue/ Tai Chi/Baduancao) | 12 | 7.5% | |
| Moxibustion | 5 | 3.1% | |
| Acupuncture/acupoint stimulation | 4 | 2.5% | |
| TCM psychological intervention | 1 | 0.6% | |
| TCM interventions with no details | 36 | 22.4% | |
| Comparisons (in 157 interventional studies) | TCM plus WM vs WM | 75 | 47.8% |
| Single arm | 28 | 17.8% | |
| Multiple comparisons | 14 | 8.9% | |
| TCM vs WM*2 | 10 | 6.4% | |
| TCM vs no intervention (in preventive study) | 11 | 7.0% | |
| TCM plus WM vs Placebo plus WM | 9 | 5.7% | |
| TCM vs Placebo (in rehabilitation study) | 7 | 4.5% | |
| Others | 3 | 1.9% | |
| Outcome measure (in 114 therapeutic trials) | Relief on symptoms or signs | 76 | 65.8% |
| Nucleic acid PCR test | 59 | 50.9% | |
| Case fatality / survival rate | 21 | 16.7% | |
| Length of stay | 37 | 31.6% | |
| Moderate-severe conversion rate | 44 | 37.7% | |
| Improvement in chest CT manifestations | 51 | 43.9% | |
| Lung function / lung injury score / oxygenation index | 30 | 26.3% | |
| Adverse events | 17 | 14.9% | |
| Primary sponsor | TCM hospital | 75 | 46.6% |
| TCM college | 14 | 8.7% | |
| TCM research institution | 10 | 6.2% | |
| WM hospital | 51 | 31.7% | |
| WM college | 1 | 0.6% | |
| Military hospital | 2 | 1.2% | |
| Pharmaceutical company | 6 | 3.7% | |
| Public health institution | 2 | 1.2% | |
| Recruitment status | Have not started recruiting | 74 | 46.0% |
| Have started recruiting | 76 | 47.2% | |
| Completed | 8 | 5.0% | |
| Suspended/withdrawn | 3 | 1.9% |
Note: 1. Suspected case is defined as a patient with a history of epidemiology and clinical manifestations, yet to be confirmed by etiological or serological tests according to China's guideline of COVID-19 [3].
2. TCM: traditional Chinese medicine; WM: western medicine, defined as conventional treatment according to China's guideline of COVID-19, including symptomatic treatment, antiviral drugs, antibiotics, respiratory and circulatory support, etc [3].