An interventional study of Fermented Codonopsis lanceolata 525mg and Fermented Codonopsis lanceolata 1050mg in Subjective Memory Complaints, sponsored by Ewha Womans University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-08-14.
Sponsored by Ewha Womans University · Not applicable, Interventional, and Treatment
The objective of this study is to demonstrate the cognitive enhancement effect and safety of Fermented Codonopsis lanceolata, using the cognitive and clinical indicators (e.g. memory, attention, and psychomotor speed) and the latest brain imaging methods for healthy adults suffering subjective cognitive impairment.
Ewha Womans University is the lead sponsor of 41 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fermented Codonopsis lanceolata 525mg/day
Dietary Supplement: Fermented Codonopsis lanceolata 525mg
Fermented Codonopsis lanceolata 1050mg/day
Dietary Supplement: Fermented Codonopsis lanceolata 1050mg
Placebo
Dietary Supplement: Placebo
Fermented Codonopsis lanceolata 525mg daily for 8 weeks
Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
Placebo daily for 8 weeks
Changes in standardized scores on a neuropsychological test battery
A composite z-scores were calculated from the scores of the neuropsychological test battery on attention and working memory. The test battery included Letter-number sequencing, Digit span (forward), and tasks from the Cambridge Neuropsychological Test Automated Battery (CANTAB) including the Match-to-Sample Visual Search, Reaction Rime, Rapid Visual Information Processing, and Stop Signal tasks.
Time frame: baseline, 4th week, 8th week
Changes in scores of the Subjective Memory Complaints Questionnaire
The Subjective Memory Complaints Questionnaire (SMCQ) contains 14 items and consists of two domains: global memory function and everyday memory function. The response to each item is rated as "yes" (1 point) or "no" (0 point). The total score ranges from 0 to 14 points, and higher points indicate larger degrees of subjective memory complaints.
Time frame: baseline, 4th week, 8th week
Number of participants with adverse events
Time frame: 4th week, 8th week
Changes of brain volume in magnetic resonance imaging assessed by computational approaches
Volumes of the clusters in the brain are reported in cubic millimeters
Time frame: baseline, 8th week
Changes of cortical thickness in magnetic resonance imaging assessed by computational approaches
Cortical thickness is measured in millimeters.
Time frame: baseline, 8th week
Functional brain changes in magnetic resonance imaging assessed by computational approaches
The Blood Oxygenation Level Dependent (BOLD) signal intensities in arbitrary units are measured in each voxel of the brain. These values are compared between the time points and groups, and the statistical values are presented as results.
Time frame: baseline, 8th week
Metabolic brain changes in magnetic resonance imaging assessed by computational approaches
Brain metabolite concentrations are assessed using the magnetic resonance spectroscopy and are estimated in mmol per liter.
Time frame: baseline, 8th week
Ran from Jul 2015 to primary completion in May 2016, 10 months.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Ewha Womans University