Actively Recruiting
Observation of Inhalation of CXMCI-01 Essential Oil on Patients With Mild Cognitive Impairment
Led by China Medical University Hospital · Updated on 2025-04-10
100
Participants Needed
2
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Memory declined and cognitive impairment are common complaints in neurology clinics. Before diagnosing as dementia, individuals will undergo a transition period, including mild cognitive impairment (MCI). Neuroinflammation is an important mechanism of memory problems. For patients with MCI, there are limited available medications. Currently, there is no standardized treatment in Taiwan. The purpose of this study is to explore alternative treatment with essential oil by inhalation to improve memory, sleep, mood, and quality of life for patients with MCI. This study will include patients who are clinically diagnosed as MCI by a neurologist. This is a double-blind randomized controlled trial, which will include 100 participants with 1:1 allocation into the intervention group and control group. The experimental group will receive 100% CXMCI-01-M Essential Oil every morning and 100% CXMCI-01-N Essential Oil by inhalation every night. The control group will receive 0.1% CXMCI-01-M Essential Oil every morning and 0.1% CXMCI-01-N Essential Oil by inhalation every night. The intervention method involves inhaling for 5 minutes, followed by wearing an essential oil necklace for 60 minutes. Examinations will be conducted before intervention (first visit, V1) and 28 days later (second visit, V2). After 28 days of finishing intervention, the third visit (V3) will be conducted. The primary outcome is the Contextual Memory Test (CMT). Secondary outcomes are Montreal Cognitive Assessment (MoCA), Taiwan Odd-Even Number Sequencing Test (TOENST), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Quality Index (PSQI), and 36-Item Short Form Health Survey (SF-36). Serum biomarkers of amyloid, tau protein, and metabolomics will be checked, as well as urine biomarkers related to neuroinflammation, including lipid peroxidation (LPO), 8-hydroxy-2-deoxyguanosine (8-OHdG), kynurenine, picolinate, quinolinate, and kynurenate. Changes in meridian energy will also be examined by M.E.A.D. and HRV before and after the intervention. It is expected that this study will contribute to the clinical application of CXMCI-01 Essential Oil in patients with MCI and improve their memory, mood, and sleep quality.
CONDITIONS
Official Title
Observation of Inhalation of CXMCI-01 Essential Oil on Patients With Mild Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older with memory and cognitive impairment
- Diagnosed with Mild Cognitive Impairment (MCI) by a neurologist based on clinical and psychological assessment
- Mini-mental state examination (MMSE) score of 23 or higher
- Clinical Dementia Rating (CDR) score of 0.5
- Completed neurological consultation including medical history, neurological exam, and olfactory function test
- No essential oil use within the past month
You will not qualify if you...
- Dementia caused by Alzheimer's disease, Parkinson's disease, vascular dementia, traumatic brain injury, CNS infections, or multiple sclerosis
- Cognitive impairment caused by brain lesions such as tumors, hydrocephalus, or severe brain atrophy
- Severe metabolic disorders affecting cognition including uncontrolled thyroid disease, electrolyte imbalance, liver dysfunction (ALT or AST > 1.5x normal), renal dysfunction (Creatinine > 1.5x normal), uncontrolled diabetes (random glucose > 200 mg/dL and HbA1c > 8%), uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg), uncorrected vitamin B12 or folate deficiency, severe anemia (Hb < 8 g/dL) or acute bleeding causing Hb < 8 g/dL
- Current severe infection (fever > 38°C, ongoing antibiotics, or abnormal white blood cell count)
- Body mass index (BMI) of 35 or higher
- Severe nasal or pharyngeal diseases affecting smell or asthma attacks in the past six months
- Substance or alcohol abuse within the past two years per DSM-5 criteria
- Diagnosis of major psychiatric disorders within the past year including major depression, schizophrenia, bipolar disorder
- Severe insomnia with symptoms over 50% of days per month for at least three months causing daytime fatigue or use of three or more sleep medications
- History of cancer under active treatment
- Use of anticholinergic or acetylcholinesterase inhibitor medications
- Concurrent use of other neuroprotective therapies including traditional Chinese medicine or dietary supplements (except long-term users over three months)
- Allergy to essential oils
- Inability to comply with essential oil inhalation procedures
- Other conditions deemed inappropriate by the principal investigator
- Inability to understand or comply with study procedures or failure to sign informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Everan Hospital
Taichung, Taiwan, 411001
Actively Recruiting
2
Everan Hospital
Taichung, Taiwan, 411
Not Yet Recruiting
Research Team
Y
Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio)
CONTACT
H
Hui-Hsuan Chen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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