Clinical trial NCT05931029: Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis
Official title: Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Cognitive Impairment
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 64
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from the Mini-Mental State Examination scale (MMSE) at 12 weeks
timeFrame: 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: Change from the clinical efficacy at 12weeks
timeFrame: 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 outcomes:
measure: Change from the Montreal Cognitive Assessment scale (MoCA) at 12 weeks
timeFrame: 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: Change from the Activities of Daily Living scale (ADL) at 12 weeks
timeFrame: 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: Change from the Geriatric Depression scale (GDS) at 12 weeks
timeFrame: 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: Change from the traditional Chinese medicine (TCM) syndrome score scale at 12 weeks
timeFrame: 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: Change from the Serological indicators at 12 weeks
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital，Sun Yat-sen University，Guangzhou 510300，China
state: Guangdong
Study officials:
References: