天王补心丹治疗轻度认知障碍患者认知功能改善的随机安慰剂对照初步临床试验方案

Cognitive improvement effects of Tian Wang Bu Xin Dan (Cheonwangbosimdan) in patients with mild cognitive impairment: protocol for a randomized placebo-controlled pilot clinical trial.

机构信息

Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, Republic of Korea; Clinical Research Center, Dongshin University Gwangju Korean Medicine Hospital, Gwangju, Republic of Korea.

Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, Republic of Korea.

出版信息

Ann Palliat Med. 2022 Oct;11(10):3320-3329. doi: 10.21037/apm-22-701. Epub 2022 Oct 11.

DOI:10.21037/apm-22-701

PMID:36267013

Abstract

BACKGROUND

It is important to develop effective treatments to prevent the progress of mild cognitive impairment to Alzheimer's disease. Cheonwangbosimdan has been widely prescribed for palpitation, anxiety, insomnia, and memory decline. We aimed to obtain clinical trial data concerning the safety and efficacy of Cheonwangbosimdan for mild cognitive impairment.

METHODS

This clinical trial would be a single-center, double-blinded, parallel-arm, prospective, randomized controlled trial. Forty-eight participants with mild cognitive impairment would be randomly allocated evenly to the placebo or Cheonwangbosimdan groups. Participants will be educated on self-management and exercise at baseline and will receive the trial medication (Cheonwangbosimdan group, Cheonwangbosimdan; placebo group, placebo) once daily for 24 weeks. Primary outcome would include the changes in the Montreal Cognitive Assessment scale scores at the end of the intervention. Secondary outcomes would include the changes in the Montreal Cognitive Assessment scale scores at 12 weeks following the first intervention and changes in the scores of the Alzheimer's Disease Assessment Scale-cognitive subscale-3, the European Quality of Life Five Dimension Five Level scale, Korean Instrumental Activities of Daily Living, Korean Activities of Daily Living, and Geriatric Depression Scale at 12 and 24 weeks following the first intervention.

DISCUSSION

The results of our trial would provide clinical trial data concerning the usefulness, safety, and efficacy of Cheonwangbosimdan in the management of mild cognitive impairment.

TRIAL REGISTRATION

Clinical Research Information Service (Date: November 26, 2021; Registration No. KCT0006787; https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&search_page=M&pageSize=10&page=undefined&seq=20869&status=5&seq_group=20869).

摘要

背景

开发有效的治疗方法来阻止轻度认知障碍向阿尔茨海默病的进展非常重要。穿心莲片已被广泛用于治疗心悸、焦虑、失眠和记忆力下降。我们旨在获得穿心莲片治疗轻度认知障碍的安全性和疗效的临床试验数据。

方法

这将是一项单中心、双盲、平行臂、前瞻性、随机对照试验。48 名轻度认知障碍患者将被平均随机分配到安慰剂或穿心莲片组。参与者将在基线时接受自我管理和运动教育，并在 24 周内每天接受试验药物（穿心莲片组，穿心莲片；安慰剂组，安慰剂）。主要结局将包括干预结束时蒙特利尔认知评估量表评分的变化。次要结局将包括首次干预后 12 周时蒙特利尔认知评估量表评分的变化，以及首次干预后 12 和 24 周时阿尔茨海默病评估量表认知分量表-3、欧洲生活质量五维五度量表、韩国日常生活活动工具、韩国日常生活活动和老年抑郁量表评分的变化。