Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change from the Mini-Mental State Examination scale (MMSE) at 12 weeks
研究概览
简要总结
This study conducted a retrospective analysis of 64 patients with mild cognitive impairment of the kidney deficiency phlegm and stasis type who underwent treatment with Naohuan Dan combined with Idebenone. The patients' cognitive function was evaluated using the Mini-Mental State Examination (MMSE) and the Montreal Cognitive Assessment (MoCA) before and after treatment. Daily living abilities were assessed using the Activities of Daily Living (ADL) scale, depression status was evaluated using the Geriatric Depression Scale (GDS), and the severity of Traditional Chinese Medicine (TCM) syndrome was assessed using the TCM diagnostic scale. Peripheral blood from the patients was also collected for analysis of neuron-specific enolase (NSE) and inflammatory factors. The aim was to evaluate the safety and feasibility of using Naohuan Dan combined with Idebenone for the treatment of mild cognitive impairment of the kidney deficiency phlegm and stasis type.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis in accordance with both Chinese medicine and Western medicine.
- •Age between 55 and 85 years, with no gender restrictions.
- •A score between 21 and 26 on the Mini-Mental State Examination (MMSE), with 1 point for primary school education.
- •Willingness to participate in the study and signing of the informed consent form.
排除标准
- •Patients with severely impaired heart, liver, kidney, or other organs functions.
- •Patients with neurological diseases that affect brain function and cognitive impairment.
- •Patients with severe depression or other mental illnesses.
- •Patients with poor compliance or cooperation who were unable to complete the study according to the protocol.
研究组 & 干预措施
The control group
The control group received Idebenone orally, at a dose of 30mg per time, three times a day, after meals for 12 consecutive weeks.
干预措施: Idebenone (Drug)
The treatmen group
The treatment group received Naohuan Dan combined with Idebenone. At a dose of one per day, delivered with warm water in the morning and evening, and taken orally for 12 consecutive weeks.
干预措施: Naohuan Dan and Idebenone (Drug)
结局指标
主要结局
Change from the Mini-Mental State Examination scale (MMSE) at 12 weeks
时间窗: The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.
The MMSE scale measures various cognitive domains, including orientation (10 points), memory (3 points), attention and calculation (5 points), recall ability (3 points) and language skills (9 points).
Change from the clinical efficacy at 12weeks
时间窗: The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.
The clinical efficacy was evaluated based on the MMSE scale, and the efficacy was calculated by comparing the scores before and after the therapy. The following criteria were used to determine the efficacy: (i) Markedly effective: ≥20% improvement in MMSE score. (ii) Effective rate: ≥12% improvement in MMSE score. (iii) Ineffective: \<12% improvement in MMSE score.
次要结局
- Change from the Activities of Daily Living scale (ADL) at 12 weeks(The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.)
- Change from the Geriatric Depression scale (GDS) at 12 weeks(The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.)
- Change from the Montreal Cognitive Assessment scale (MoCA) at 12 weeks(The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.)
- Change from the Serological indicators at 12 weeks(The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.)
- Change from the traditional Chinese medicine (TCM) syndrome score scale at 12 weeks(The time of measurement for the scale occurred twice, with the first measurement taking place before subjects were enrolled, and the second occurring at the end of their 12-week continuous medication period. Each assessment will last for one day.)