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

NCT05931029 | Completed

• 1 other identifier: SYSKY-2022-332-01
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (5)

• Change from the Montreal Cognitive Assessment scale (MoCA) at 12 weeks

  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 Activities of Daily Living scale (ADL) at 12 weeks

  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 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 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

  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.

Study Arms (2)

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.

Drug: Idebenone

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.

Drug: Naohuan Dan and Idebenone

Interventions

Idebenone DRUG

The control group took Idebenone orally for 12 weeks.

The control group

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.

The treatmen group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital，Sun Yat-sen University，Guangzhou 510300，China

Guangzhou, Guangdong, 510220, China

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

idebenone

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: July 5, 2023
• Study Start: May 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication
• Access Criteria: If necessary, please request all data to the email address of the person in charge：hqhui84181833@sina.com

Locations

CN (1)