An interventional study of PICOZYME ET in Essential Tremor, sponsored by Pico Entech Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Pico Entech Co., Ltd. · Not applicable, Interventional, and Treatment
This is a sponsor-initiated, single-arm, single-center clinical trial designed to evaluate the efficacy and safety of an ALDH-containing food supplement (PICOZYME ET) in patients with Essential Tremor (ET). Participants will consume the investigational product daily for three months, and clinical outcomes will be assessed using the Clinical Rating Scale for Tremor (CRST) and the Activities of Daily Living (ADL) scale. Additional exploratory analyses will evaluate changes in metabolic biomarkers and brain function via imaging and blood tests.
Essential Tremor (ET) is one of the most common adult movement disorders, characterized by involuntary rhythmic tremors, primarily affecting the hands. Although not life-threatening, ET significantly impacts quality of life and daily functioning. Recent studies suggest that oxidative stress and impaired GABAergic inhibition may be involved in its pathophysiology, and aldehyde dehydrogenase (ALDH) is believed to play a role in mitigating these mechanisms.
This single-center, open-label, sponsor-initiated study is funded by PICO Entech Corp and conducted at Korea University Anam Hospital under the supervision of the institutional IRB. The trial aims to evaluate the efficacy and safety of an ALDH-containing food supplement (PICOZYME ET) in patients with ET. A total of 40 adult participants diagnosed with ET will be enrolled and instructed to consume the investigational food product twice daily for three months. Efficacy will be measured by changes from baseline in the Clinical Rating Scale for Tremor (CRST) and Activities of Daily Living (ADL) scores.
Secondary outcomes include safety and biomarker analysis through blood tests. Exploratory outcomes include changes in metabolic activity via FDG PET-CT imaging, levels of oxidative stress biomarkers (malondialdehyde, total aldehyde), and potential associations with GABA-related metabolic pathways.
The study has received IRB approval from Korea University Anam Hospital and includes oversight from a Data Safety Monitoring Board (DSMB). All participants will provide written informed consent before enrollment.
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's enrollment of 31 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.
Browse Essential Tremor studies →This is the only study on the registry with Pico Entech Co., Ltd. as lead sponsor.
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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.
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.
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.
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.
Participants in this arm will receive an ALDH-containing food supplement (PICOZYME ET) twice daily for 3 months. The study will assess changes in tremor severity, quality of life, and exploratory metabolic biomarkers.
Dietary Supplement: PICOZYME ET
The investigational product is a dietary supplement containing aldehyde dehydrogenase (ALDH), administered orally twice daily (one packet in the morning and one in the evening) for 3 months before meals.
Also known as: ALDH food supplement
Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months
The CRST is a validated clinical tool used to quantify tremor severity. It includes assessments of postural, action, and intention tremor, as well as functional disability. Total scores range from 0 to 160, with higher scores indicating more severe tremor.
Time frame: Baseline and 3 months
Change in Activities of Daily Living (ADL) score from baseline to 3 months
ADL will be assessed using the QUEST (Quality of Life in Essential Tremor) questionnaire. Higher scores indicate greater functional impairment.
Time frame: Baseline and 3 months
Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine)
Measurement of 24-hour urinary catecholamine levels (epinephrine, norepinephrine, dopamine) in µg/day at baseline and 3 months to evaluate oxidative stress.
Time frame: Baseline and 3 months
Change in Random Urinary Malondialdehyde
Semi-quantitative measurement of malondialdehyde in random urine using dipstick analysis (DFI FRC 50SF analyzer and Free RadiCheck test strips), with results reported as relative values.
Time frame: Baseline and 3 months
Change in Serum C-Reactive Protein (CRP) Level
Measurement of serum CRP concentration in mg/L at baseline and 3 months.
Time frame: Baseline and 3 months
Incidence of adverse events during the intervention period
Adverse events (e.g., nausea, gastrointestinal discomfort) will be monitored and recorded throughout the 3-month supplementation period to assess safety.
Time frame: Through study completion (up to 3 months)
Plan to share: No — Individual participant data (IPD) will not be shared. This study involves a small, single-site intervention, and data sharing is not planned due to institutional policy and privacy considerations.
Ran from Mar 2025 to primary completion in Jan 2026, 9 months.
Of 95 interventional studies with no phase under Essential Tremor, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 93. This study's 9 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Feb 2026 → Jan 2026 and completion Feb 2026 → Jan 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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