UNASSIGNED: This trial is a randomized controlled trial. Patients who meet the criteria will be recruited and randomly divided into 2 groups. One group will receive acupuncture treatment and another group will not receive acupuncture treatment. Both groups will receive conventional treatment. In addition, 20 healthy individuals will be recruited who will not receive any treatment. The total course of treatment is 14 days. The primary outcome is multimodal MRI analysis. For safety assessment, adverse events will be observed and recorded.
UNASSIGNED: The study involving human subjects was reviewed and approved by the Ethics Committee of IRB of The First Teaching Hospital of Tianjin University of TCM (TYLL2023[K]031). This study complied with the Declaration of Helsinki. Written informed consent about this study was provided by the participants. The results of this study will be published in a peer-reviewed journal.
UNASSIGNED: Chinese Clinical Trial Registration Center (ChiCTR2300078315) https://www.chictr.org.cn/.
■本试验为随机对照试验。符合标准的患者将被招募并随机分为2组。一组将接受针灸治疗,另一组将不接受针灸治疗。两组均接受常规治疗。此外,将招募20名不接受任何治疗的健康个体。总疗程为14天。主要结果是多模态MRI分析。对于安全评估,将观察并记录不良事件。
■涉及人类受试者的研究得到了天津中医药大学第一教学医院IRB伦理委员会的审查和批准(TYLL2023[K]031)。这项研究符合赫尔辛基宣言。参与者提供了关于本研究的书面知情同意书。这项研究的结果将发表在同行评审的期刊上。
■中国临床试验注册中心(ChiCTR2300078315)https://www.chictr.org.cn/.