💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Aged 50 years or older, presenting 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) ≥ 23 and Clinical Dementia Rating (CDR) = 0.5.
2. Neurological consultation: Participants must undergo a neurology consultation, including medical history review, neurological examination, and olfactory function testing.
3. No essential oil use within the past month.
Exclusion Criteria:
1. Dementia caused by other conditions, including: Alzheimer's disease, Parkinson's disease, vascular dementia, traumatic brain injury, central nervous system infections or multiple sclerosis
2. Cognitive impairment due to brain lesions, such as: brain tumors, hydrocephalus, severe brain atrophy
3. Severe metabolic disorders potentially affecting cognitive function, including:
1. Uncontrolled hyperthyroidism or hypothyroidism
2. Uncorrected electrolyte imbalance
3. Liver dysfunction (ALT or AST \> 1.5× normal upper limit)
4. Renal dysfunction (Creatinine \> 1.5× normal upper limit)
5. Uncontrolled or poorly managed diabetes (Random glucose \> 200 mg/dL and HbA1c \> 8%)
6. Uncontrolled or poorly managed hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg)
7. Uncorrected vitamin B12 or folate deficiency
8. Severe anemia (Hb \< 8 g/dL) or acute bleeding causing Hb \< 8 g/dL
9. Current severe infection (fever \> 38°C, ongoing antibiotic use, or abnormal WBC count)
10. Body Mass Index (BMI) ≥ 35
4. Severe nasal or pharyngeal diseases affecting olfactory function, or history of asthma attacks in the past six months.
5. Substance or alcohol abuse within the past two years, meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria.
6. Diagnosis of psychiatric disorders within the past year, including: Major depressive disorder, schizophrenia, bipolar disorder (DSM-5 criteria),
7. Severe insomnia, defined as:
(1) Experiencing insomnia symptoms for more than 50% of days per month for at least three months, causing daytime fatigue.
(2) Use of three or more sleep-related medications (e.g., benzodiazepines or Z-drugs).
8\. History of cancer under active treatment. 9. Use of anticholinergic or acetylcholinesterase inhibitor medications. 10.Concurrent use of other neuroprotective therapies, including traditional Chinese medicine or dietary supplements (except for long-term users exceeding three months).
11.Allergy to essential oils. 12.Inability to comply with essential oil inhalation procedures. 13.Other conditions deemed inappropriate by the principal investigator. 14.Inability to understand or comply with study procedures, or failure to sign the informed consent form.
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