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

Sun Yat-sen University

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Drug: Idebenone; Drug: Naohuan Dan and Idebenone

Study type: Observational

Funder types: Other

Identifiers

NCT05931029

SYSKY-2022-332-01

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

64 participants in 2 patient groups

The control group

Description:

The control group received Idebenone orally, at a dose of 30mg per time, three times a day, after meals for 12 consecutive weeks.

Treatment:

Drug: Idebenone

The treatmen group

Description:

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.

Treatment:

Drug: Naohuan Dan and Idebenone