CTRI/2026/07/113968进行中（未招募）4 期
A randomized, double-blind, placebo controlled, parallel group clinical study for the comparative evaluation of efficacy and tolerability of low molecular weight chondroitin sulfate in adult subjects with mild cognitive impairment MCI - NIL
DAEHAN CHEMTECH CO., LTD.0 个研究点目标入组 130 人开始时间: 2026年7月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male and female subjects aged between 50-70 years.
- •Subjects who self-report mild cognitive decline.
- •Subjects with Hindi Mental State Examination HMSE score between
排除标准
- •Subjects with a diagnosis of dementia as per the Diagnostic and Statistical Manual of Mental Disorders DSM
- •Subjects with a diagnosis of attention deficit hyperactivity disorder ADHD as per the Diagnostic and Statistical Manual of Mental Disorders DSM
- •Subjects who are currently undergoing structured exercise therapy or dietary therapy.
- •Subjects with cognitive impairment due to organic brain disease or mental or psychiatric illness.
- •Subjects with a Hospital Anxiety and Depression Scale HADS depression subscale score greater than
- •Subjects with a Hospital Anxiety and Depression Scale HADS anxiety subscale score greater than
- •Subjects with an Insomnia Severity Index ISI score greater than
- •Subjects with an Alcohol Use Disorders Identification Test AUDIT score greater than
- •Subjects with a history of antipsychotic medication use within the 3 months preceding the screening visit.
- •Subjects who are currently on or were in the past 4 weeks preceding the screening visit on any medications that could impair cognitive function, including anticholinergic medications diphenhydramine, atropine, benzodiazepines alprazolam, lorazepam, diazepam, antiepileptic drugs topiramate, levetiracetam, phenytoin, antihypertensive medications mlodipine, beta blockers, diuretics, opioids codeine, oxycodone, hydrocodone, antihistamines diphenhydramine, chlorpheniramine, cetirizine, and tricyclic antidepressants amitriptyline, imipramine, nortriptyline.
- •Subjects who have received treatment with any approved or investigational health supplements for improvement of cognition and memory within the past 1 month preceding the screening visit.
- •Subjects with a history of traumatic brain injury with loss of consciousness or convulsion.
- •Subjects with uncontrolled blood pressure, diabetes mellitus, or hypothyroidism.
- •Subjects with abnormal laboratory findings such as AST or ALT greater than 3 times the upper limit of normal, Hb less than or equal to 8 g per dL, platelet count less than 100000 per mm3, or TSH less than or equal to 0.1 microIU per mL or greater than or equal to 10 microIU per mL.
- •Subjects with serum creatinine greater than 3 times the upper limit of normal or with acute or chronic renal failure requiring dialysis.
- •Subjects participating in another clinical trial within the 3 months preceding the screening visit.
- •Subjects with severe hearing or vision impairment that prevents efficacy evaluation.
- •Subjects with any neurological, congenital or acquired, vascular, or systemic disorder that could affect the efficacy assessments.
- •Subjects with any clinically significant disease that, in the investigators opinion, may substantially affect the subjects overall well being, including cardiovascular, endocrine, immune, respiratory, renal, urinary, neuropsychiatric, musculoskeletal, inflammatory, hematological, or gastrointestinal diseases.
研究者
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