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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idebenone | Drug | The control group took Idebenone orally for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the Mini-Mental State Examination scale (MMSE) at 12 weeks | 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). | 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 clinical efficacy at 12weeks | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from the Montreal Cognitive Assessment scale (MoCA) at 12 weeks | The MoCA scale is a widely used screening tool for detecting mild cognitive impairment. The total score on the MoCA scale is 30, and a score of 26 or higher is considered to indicate normal cognitive function. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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The participants were selected at the Traditional Chinese Medicine's and Rehabilitation Medicine's out-patient clinic or inpatient department of Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital，Sun Yat-sen University，Guangzhou 510300，China | Guangzhou | Guangdong | 510220 | China |
All IPD that underlie results in a publication
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Starting 6 months after publication
If necessary, please request all data to the email address of the person in charge：hqhui84181833@sina.com
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2022 | Jun 17, 2023 |
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| Naohuan Dan and Idebenone |
| Drug |
The treatment group took Naohuan Dan combined with Idebenone for treatment. Naohuan Dan is a granular preparation taken once a day, while Idebenone is a tablet taken three times a day for a total of 12 weeks. |
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| Change from the Activities of Daily Living scale (ADL) at 12 weeks | The ADL scale is used to assess the participants' ability to perform daily living activities. The total score on the ADL scale is 100 points. | 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 GDS scale is a self-report assessment tool used to detect and measure the severity of depression in older adults. The total score on the GDS scale is 30 points. | 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 TCM clinical symptoms of the participants were evaluated using the TCM syndrome score scale. This tool assesses the severity of specific TCM symptoms and divides them into four grades: none, mild, moderate, and severe, with 0, 2, 4, and 6 points (for main symptoms) or 0, 1, 2, and 3 points (for secondary symptoms), respectively. | 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 | Blood samples were collected from the participants before and after the therapy via cubital venipuncture. Enzyme-linked immunosorbent assay (ELISA) was used to determine the serum levels of neuron-specific enolase (NSE), interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α). | 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. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form | Aug 30, 2022 | Jun 6, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C036619 | idebenone |
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