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fNIRS Evaluation of JianNaoTongLuo Granules for Mild Cognitive Impairment in Elderly Patients with Phlegm-Dampness Obstruction

fNIRS Evaluation of JianNaoTongLuo Granules for Mild Cognitive Impairment in Elderly Patients with Phlegm-Dampness Obstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000484
Enrollment
Unknown
Registered
2024-09-26
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild cognitive impairment

Interventions

Test group (herbal group):Chinese herbal medicine
control group (placebo group):Take a placebo

Sponsors

Hubei Provincial Hospital of Integrated Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1: Meet the diagnostic criteria for MCI; meet the diagnostic criteria for the phlegm-turbidity-masking syndrome; 2: Be at least 60 years of age; 3: No severe hearing speech or comprehension impairments and can complete all cognitive assessments; 4: Those who do not have serious underlying diseases and can cooperate to complete the treatment; 5: No mental illness etc; 6: Informed consent to treatment and voluntary signing of the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1: Combined severe underlying disease unstable; CDR rating of dementia (=0.5 for suspected dementia; =1.0 for mild dementia; =2.0 for moderate dementia; =3.0 for severe dementia); 2: Those who have speech impairment severe vision loss hearing impairment and cannot cooperate with assessment and treatment; 3: Severe mental illness (e.g. depression schizophrenia) and epilepsy; taking medications that may affect cognition: e.g. antipsychotics sedative-hypnotics antihistamines theophyllines etc; 4: Those who are unable to complete daily activities independently due to various illnesses and physical weakness before the current illness which seriously affects the evaluation of the efficacy of the treatment; 5: Those who are allergic to the components of the test drug or have a history of alcohol or drug abuse; 6: 6. Women who are pregnant breastfeeding or planning a pregnancy in the last six months; 7: Those who are participating in other clinical trials or have participated in clinical trials of other drugs that have not been completed for more than 3 months; 8: patients who in the judgment of the investigator are not suitable for participation in this trial.

Design outcomes

Primary

MeasureTime frame
Montreal cognitive assessment scaleMoCA;

Secondary

MeasureTime frame
Instru-mental Activities of Daily Living Scale ADL;Intestinal microbiota testing;Mimi-Mental State ExaminationMMSE;PSQI;TCM Symptom Diagnosis Form;Functional near - infrared spectroscopyfNIRS;Trail Marking TestTMT;digit span testDST;

Countries

CHINA

Contacts

Public ContactXia Wenguang

Hubei Provincial Hospital of Integrated Chinese and Western Medicine

docxwg@163.com13377897278

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026