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Clinical trial for evaluation of efficacy on cognitive function of MT104

Single center, randomized, double-blind, placebo-controlled clinical trial for evaluation of efficacy on cognitive function and safety of MT104

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0006499
Enrollment
86
Registered
2021-08-25
Start date
2021-07-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

None listed

Interventions

Dietary Supplement : For 12 weeks, take MT-104(Cuscuta chinensis Lam, C. japonica Choisy and Lactobacillus paracasei) or Placebo, once a day, 1 capsule at a time, 30 minutes after breakfast.

Sponsors

Kyung Hee University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects of 50 to 80 years of age 2) Subjects with mild cognitive impairment - subjects or guardian claim cognitive impairment - subjects with decreased verbal or visual memory score of SNSB test below -1SD 3) Subjects who consent participation of study and write written consent

Exclusion criteria

Exclusion criteria: 1) Subjects who experienced allergy or adverse events when administered functional food or drugs 2) Subjects who diagnosed with dementia, brain tumor, hydrocephalus 3) Subjects with gastrointestinal disturbance, or have psychiatric disorders (schizophrenia, epilepsy, alcohol intoxication, anorexia, abnormally increased appetite 4) Subjects with stroke, heart disease (heart failure, angina pectoris, myocardial infarction), malignancy, narrow angle glaucoma, uncontrolled hypertension (blood pressure over 60/100mmHg), or pulmanary diseases 5) Subjects with severe renal diseases or hepatic diseases (serum creatinine> 2.0 mg/dl, ALT, AST, alkaline phosphatase> normal upper limit x 2.5) 6) Subjects with uncontrolled blood glucose with hypoglycemic drugs (fasting blood glucose over160mg/dL), platelet (under 150,000/mm3) hemoglobin (male 9.5g/dL, female 9.0g/dL) 7) Subjects who treated with oral steroids, thyroid hormones or administered drugs or functional food which can change absorption, metabolism, and excretion of test food, or subjects who participated with other clinical trial within 3 month 8) Subjects who undergo surgery within 6 month or treated with prohibited treatment (acupuncture or treatment & functional food for brain function or drugs with abuse potential) 9) Subjects who undergo stomach resection or surgery which can influence drug absorption 10) pregnant woman, lactating woman, or fertile woman who do not consent proper contraception (oral contraceptive agent, hormone, uterine device, spermicide) 11) Subjects who donate blood with in 2 month or donate blood fraction within 1 month 12) Subjects who cannot participate in the study by investigator

Design outcomes

Primary

MeasureTime frame
Improvement rate of total score of K-MMSE

Secondary

MeasureTime frame
Improvement rate of total score of K-MoCA;Improvement rate of Seoul Verbal Learning Test (SVLT) score ;Improvement rate of Rey Complex Figure Test (RCFT) score ;Improvement rate of SVLT (immediate recall, recognition) score ;Improvement rate of RCFT (immediate recall, recognition) score

Countries

Korea, Republic of

Contacts

Public ContactEunjeong Eo

Kyung Hee University Hospital

eoej07@gmail.com+82-2-958-9456

Outcome results

None listed

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