Clinical trial NCT05947396: Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
Official title: Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurodegenerative Diseases
Lead sponsor: Beijing University of Chinese Medicine
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 10
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Explore the effects of natural plant flavonoids on the positive intervention mechanism of neurotransmitter transmission physiological indicators changes (EEG) in the brain of the study subjects;
2. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.


Eligibility criteria: Inclusion Criteria:

1. Age: 25-70 years
2. Patients complaining of sleep disorders, mood disorders (unstable mood, irritability, depression, and anxiety), and cognitive decline (people with memory, decreased reaction time, BPSD symptoms) within one month
3. Montreal Cognitive Assessment Scale (MOCA) score ≤26; if the MOCA score is not satisfied, then Pittsburgh Sleep Quality Index (PSQI) score \>10 and Hamilton Anxiety Scale (HAMA) score \>14 or Hamilton Depression Scale (HAMD) score ≥8 are required
4. Patients who can understand and communicate in language, and complete aphasia patients are not included;
5. Patients who agree to participate in this clinical observation and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
2. Patients with severe uncontrolled hypertension;
3. Patients who have taken antipsychotic drugs within the past two weeks;
4. Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
5. Patients with various malignant tumors;
6. Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
7. Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
8. Pregnant or lactating women;
9. Patients allergic to the known ingredients used in this trial;
10. Patients with active ulcers or bleeding tendencies;
11. Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
12. Other patients who are deemed unsuitable to participate in this trial by the investigators.

Primary outcomes:
measure: Electroencephalogram (EEG)-Slow wave length
timeFrame: 4 weeks
measure: Electroencephalogram (EEG)-Slow wave frequency
timeFrame: 4 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 4 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 4 weeks
measure: Hamilton Anxiety Rating Scale (HAMA)
timeFrame: 4 weeks
measure: Hamilton Depression Scale(HAMD)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Numerry of participating with adverse events
timeFrame: baseline, 4 weeks
measure: Adverse event occurrence rate
timeFrame: baseline, 4 weeks
measure: Abnormality rate of routine blood tests
timeFrame: baseline, 4 weeks
measure: Liver function-Alanine aminotransferase#ALT#
timeFrame: baseline, 4 weeks
measure: Liver function-Aspartate aminotransferase (AST)
timeFrame: baseline, 4 weeks
measure: Liver function-Total Protein(TP)
timeFrame: baseline, 4 weeks
measure: Electrocardiogram
timeFrame: baseline, 4 weeks
measure: Body temperature
timeFrame: baseline, 4 weeks
measure: Heart rate
timeFrame: baseline, 4 weeks
measure: Number of breaths in 1 min
timeFrame: baseline, 4 weeks
measure: Blood pressure-Diastolic blood pressure(mmHg)
timeFrame: baseline, 4 weeks
measure: Blood pressure-Systolic blood pressure(mmHg)
timeFrame: baseline, 4 weeks
Locations:
Study officials:
References: