Mild Cognitive ImpairmentNCT05931029
Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis
An observational study of Mild Cognitive Impairment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Idebenone and Naohuan Dan and Idebenone
- Type of treatment
- Pill or oral medicine
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital，Sun Yat-sen University，Guangzhou 510300，China
Guangzhou, Guangdong, 510220
About this study
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
- Being tested
- Idebenone, Naohuan Dan and Idebenone
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IdebenoneDrug
The control group took Idebenone orally for 12 weeks.
Naohuan Dan and IdebenoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Naohuan Dan and Idebenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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 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.
Measured: 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 ADL scale is used to assess the participants' ability to perform daily living activities. The total score on the ADL scale is 100 points.
Measured: 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 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.
Measured: 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 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.
Measured: 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
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-α).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 May 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931029
- Sponsor's protocol ID
- SYSKY-2022-332-01
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Therapeutic Effects of Naohuan Dan and Idebenone in Treating Mild Cognitive Impairment With Kidney Deficiency and Phlegm Stasis
- ClinicalTrials.gov ID
- NCT05931029
- Acronym / sponsor ID
- SYSKY-2022-332-01
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | Drug: IdebenoneThe control group received Idebenone orally, at a dose of 30mg per time, three times a day, after meals for 12 consecutive weeks. |
| The treatmen group | – | Drug: Naohuan Dan and IdebenoneThe 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IdebenoneThe control group took Idebenone orally for 12 weeks. | Drug | The control group |
| Naohuan Dan and IdebenoneThe 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. | Drug | The treatmen group |
Primary outcome
Change from the Mini-Mental State Examination scale (MMSE) at 12 weeks
Time frame: 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.
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).
Change from the clinical efficacy at 12weeks
Time frame: 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.
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.
5 secondary outcomes
Change from the Montreal Cognitive Assessment scale (MoCA) at 12 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the Mini-Mental State Examination scale (MMSE) at 12 weeks (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.