Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis

Mild Cognitive Impairment Clinical Trial

Official title:

Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931029
• Other study ID #: SYSKY-2022-332-01
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Idebenone
The control group took Idebenone orally for 12 weeks.
• Naohuan Dan and Idebenone
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.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510300,China	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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-a).	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.