Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases

Neurodegenerative Diseases Clinical Trial

Official title:

Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05947409
• Other study ID #: SMARTO ONE-202305-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Beijing University of Chinese Medicine
• Contact: Li Liu
• Phone: 16619733315
• Email: lily0496[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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 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.

Related Conditions & MeSH terms

• Neurodegenerative Diseases

Intervention

Drug:
• SMARTO ONE
The SMARTO ONE® small molecule natural flavonoid compound product is provided by Beijing Jiafurui Biological Technology Co., Ltd. The intervention agent formula consists of extracts from Polygonum cuspidatum leaves, Fructus ligustri lucidi, Prunus mume, Semen ziziphi spinosae, celery, resistant maltodextrin, and steviol glycoside. Each package of the test product (3g) contains a total flavonoid content of 150mg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mei Han

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montreal Cognitive Assessment (MoCA)	This outcome measure assesses cognitive ability and memory, with evaluation based on a scoring system.The total score ranges from 0 to 30 points, with scores lower than 26 indicating the presence of cognitive impairment. The lower the score, the more severe the disease.	4 weeks
Primary	Pittsburgh Sleep Quality Index (PSQI)	The evaluation criteria for this outcome measure are as follows: 0-5 points indicate very good sleep quality; 6-10 points indicate average sleep quality; 11-15 points indicate poor sleep quality; 16-21 points indicate very poor sleep quality.	4 weeks
Primary	Hamilton Anxiety Rating Scale (HAMA)	The evaluation criteria for this outcome measure are as follows: 0-6 points indicate no anxiety symptoms; 7-14 points indicate possible anxiety; 15-21 points indicate definite anxiety; 22-29 points indicate significant anxiety; and scores exceeding 29 points suggest severe anxiety.	4 weeks
Primary	Hamilton Depression Scale(HAMD)	The evaluation criteria for this outcome measure are as follows:a score of less than 8 is normal, a score of 8-20 may indicate depression, a score of 21-35 may indicate depression, and a score of more than 35 may not indicate severe depression	4 weeks
Secondary	Numerry of participating with adverse events	This is a safety outcome.	baseline, 4 weeks
Secondary	Adverse event occurrence rate	This is a safety outcome.	baseline, 4 weeks
Secondary	Abnormality rate of routine blood tests	This is a safety outcome. Included in the outcome indicators are red blood cell count (WBC), haemoglobin concentration (Hb), white blood cell count (WBC), neutrophil count (Neut), lymphocyte count (Lymph), monocyte count (Mono), eosinophil count (Eos), basophil count (Baso) and platelet count (PLT). The abnormal blood count rate was obtained by dividing the number of people with abnormal blood counts by the total number of people with abnormal blood counts.	baseline, 4 weeks
Secondary	Liver function-Alanine aminotransferase#ALT#	This is a safety outcome.	baseline, 4 weeks
Secondary	Liver function-Aspartate aminotransferase (AST)	This is a safety outcome.	baseline, 4 weeks
Secondary	Liver function-Total Protein(TP)	This is a safety outcome.	baseline, 4 weeks
Secondary	Electrocardiogram	This is a safety outcome.This outcome measure primarily observes ST segment changes to evaluate the presence or improvement of myocardial ischemia.	baseline, 4 weeks
Secondary	Body temperature	This is a safety outcome.	baseline, 4 weeks
Secondary	Heart rate	This is a safety outcome.	baseline, 4 weeks
Secondary	Number of breaths in 1 min	This is a safety outcome.	baseline, 4 weeks
Secondary	Blood pressure-Diastolic blood pressure(mmHg)	This is a safety outcome.	baseline, 4 weeks
Secondary	Blood pressure-Systolic blood pressure(mmHg)	This is a safety outcome.	baseline, 4 weeks