NCT05931029

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Idebenone	The control group took Idebenone orally for 12 weeks.
DRUG	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.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2023-07-05
• Last updated: 2023-07-05

Locations

1 site across 1 country: China