A human trial to evaluate the efficacy and safety of Gastrodia elata Blume extract on improvement of Cognitive Functio
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0006605
- Lead Sponsor
- Wonkwang University. Iksan Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1) Males and females aged 45-65 years over at the screening examination
2) Participants who have mini mental state examination score of 20 to 28.
3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions.
1) The patients who have a history of alcoholism dependency/abuse within the last 3 months before the screening examination.
2) The patients who take medicine, health functional foods or oriental medicine within the last 1 month before the screening examination.
3) Patients who have participated in other clinical trials within the last 3 months before the screening examination.
4) Patients who have laboratory test outcomes as follow.
? AST(Aspartate aminotransferase), ALT(Alanine Transaminase) > three times the normal limit
? Serum Creatinine > 2.0 mg/dL
5) Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ADAS-cog(Alzheimer’s Disease assessment Scale cognitive subscale)
- Secondary Outcome Measures
Name Time Method K-MMSE(Korean Mini-Mental Status Examination);Brain-derived neurotrophic factor;Amyloid ß