Yue yang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.
Huangshi Hospital of Traditional Chinese Medicine, Huangshi, Hubei, 435000, China.
Trials. 2020 Aug 27;21(1):751. doi: 10.1186/s13063-020-04693-5.
In December 2019, pneumonia associated with the 2019 novel coronavirus (COVID-19) emerged in Wuhan, China. The number of cases has increased rapidly. Patients with severe disease have a poor prognosis, and there are no effective therapies for COVID-19. Only rapid advice guidelines for symptomatic supportive care have been used. A traditional Chinese medicine rehabilitation (TCMR) program consisting of acupressure therapy and Liu Zi Jue Qigong can be used as a complementary therapy for COVID-19. Hence, we designed a randomized trial to evaluate the efficacy and advantages of TCMR for treating patients with severe COVID-19.
METHODS/DESIGN: This is a parallel-design, two-arm, analyst assessor-blinded, randomized controlled trial. A total of 128 patients with COVID-19 aged from 20 to 80 years will be recruited and assigned randomly into a guideline therapy group and a guideline therapy plus TCMR group at a 1:1 ratio. Patients in both groups will receive guideline therapy. The patients in the intervention group will perform acupressure therapy and Liu Zi Jue Qigong exercises in addition to conventional treatments twice a day and will be persistent from admission to discharge. The primary outcome will be measured with the Modified Medical Research Council Dyspnea Scale, and the secondary outcomes will include the Activities of Daily Living Barthel Index Scale, Patient Health Questionnaire-9 Scale, and the Respiratory Symptoms Scale. The assessments of the clinical scales will be performed at three points (before treatment, the 7th day during hospitalization, and the discharge day). Adverse events will be noted and recorded for the safety evaluation.
This trial will provide high-quality evidence of the value of TCMR, which consists of acupressure therapy and Liu Zi Jue Qigong exercises, for treating patients with severe COVID-19.
Chinese Clinical Trial Registry ChiCTR2000029994 . Registered on 18 February 2020.
2019 年 12 月，新型冠状病毒（COVID-19）相关肺炎在中国武汉出现。病例数量迅速增加。重症患者预后不良，目前尚无 COVID-19 的有效治疗方法。仅使用了对症支持治疗的快速建议指南。一种由指压疗法和六字诀气功组成的中医康复（TCMR）方案可用作 COVID-19 的补充治疗。因此，我们设计了一项随机试验，以评估 TCMR 治疗重症 COVID-19 患者的疗效和优势。
方法/设计：这是一项平行设计、双臂、评估者盲法、随机对照试验。将招募 128 名年龄在 20 至 80 岁之间的 COVID-19 患者，并以 1:1 的比例随机分为指南治疗组和指南治疗加 TCMR 组。两组患者均接受指南治疗。干预组患者除常规治疗外，每天进行两次指压疗法和六字诀气功锻炼，从入院到出院持续进行。主要结局将通过改良医学研究委员会呼吸困难量表进行测量，次要结局将包括日常生活活动 Barthel 指数量表、患者健康问卷-9 量表和呼吸症状量表。临床量表的评估将在三个时间点进行（治疗前、住院第 7 天和出院日）。将记录并记录不良事件以进行安全性评估。
这项试验将为 TCMR（包括指压疗法和六字诀气功）治疗重症 COVID-19 患者的价值提供高质量的证据。
中国临床试验注册中心 ChiCTR2000029994。注册于 2020 年 2 月 18 日。
