The First Affiliated Hospital of Henan University of Chinese Medicine, 19 Renmin Road, Zhengzhou, 450099, China.
The Affiliated Hospital of Henan Academy of Chinese Medicine, Zhengzhou, 450004, China.
Trials. 2022 Aug 17;23(1):665. doi: 10.1186/s13063-022-06625-x.
Acquired immune deficiency syndrome is caused by humans and is high worldwide. Active antiretroviral therapy emerged in the late 1990s and is effective against AIDS. However, despite the extensive research on AIDS, there is still no vaccine or cure. The benefits of traditional Chinese medicine (TCM) for AIDS are increasingly recognised, especially by patients with asymptomatic HIV infection.
METHODS/DESIGN: The proposed trial will enrol 216 eligible patients who will be randomised into treatment and control groups. After 72 weeks of intervention, the efficacy and safety of TCM for patients with AIDS will be assessed. The variables that will be measured include clinical symptoms, TCM syndromes, viral load, immunological indicators, inflammatory factors, quality of life, patient-reported outcomes and safety assessment.
The study aim to compare the effectiveness and safety of TCM for asymptomatic AIDS and explore its potential underlying mechanism. Additionally, the findings will provide a reference for the use of TCM to delay the onset and control the progression of HIV/AIDS.
Chinese Clinical Trial Registry ChiCTR1800018365. Registered on 13 September 2018.
艾滋病是由人类获得性免疫缺陷病毒引起的，在全球范围内发病率较高。上世纪 90 年代末出现的高效抗反转录病毒疗法对艾滋病有效。然而，尽管对艾滋病进行了广泛的研究，仍然没有疫苗或治愈方法。中医药治疗艾滋病的疗效正逐渐得到认可，尤其是对无症状 HIV 感染者。
方法/设计：本试验将纳入 216 例符合条件的患者，随机分为治疗组和对照组。干预 72 周后，评估中医药治疗艾滋病患者的疗效和安全性。将测量的变量包括临床症状、中医证候、病毒载量、免疫指标、炎症因子、生活质量、患者报告的结果和安全性评估。
本研究旨在比较中医药治疗无症状艾滋病的有效性和安全性，并探讨其潜在的作用机制。此外，研究结果将为中医药延缓 HIV/AIDS 发病和控制其进展提供参考。
中国临床试验注册中心 ChiCTR1800018365。于 2018 年 9 月 13 日注册。
