CTRI/2026/03/105341招募中不适用
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of SOBC-730 in improving memory function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The study is designed to evaluate the effect of SOBC-730 in improving memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test product or placebo. Participants will be assessed using memory assessment scales at Baseline. The participants will be given investigational products for 8 weeks at a dose of 350mg/day. Memory assessment will be done after Week 4 and Week 8, after intake of test product and placebo. Biomarkers were assessed at Baseline and end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female participant aged 18 to 65 years at the time of screening
- •Montreal Cognitive Assessment (MoCA) score between 22 and 26, inclusive, at screening
- •Subjective distractibility without ADHD diagnosis
- •Education level : over high school
- •Subjective complaints of memory difficulty, distractibility, or reduced cognitive performance without a diagnosis of dementia
- •Ability to understand and complete digital or paper-based cognitive assessments
- •Willingness to maintain usual lifestyle habits and refrain from initiating new cognitiveenhancing supplements or medications during the study
- •Ability and willingness to comply with all trial procedures and visit schedules
- •Provision of written informed consent prior to any trial-specific procedures.
排除标准
- •Diagnosis of dementia, Alzheimer’s disease, or other major neurocognitive disorder
- •History of significant neurological conditions, including but not limited to stroke, epilepsy, traumatic brain injury, brain tumor, or neurodegenerative disease
- •Severe psychiatric disorders, including major depressive disorder, schizophrenia, bipolar disorder, alcohol dependence, or substance abuse
- •Use of medications that may interfere with cognitive outcomes within 4 weeks prior to screening, including: Dementia treatment drugs, Thyroid hormone drugs, Central nervous system stimulants, Antipsychotics, Anticholinergic drugs, Brain metabolism enhancers
- •Diagnosed sleep disorders that may significantly affect cognitive function
- •Uncontrolled endocrine disorders, including uncontrolled diabetes or abnormal thyroid function
- •Clinically significant abnormal laboratory values at screening, including ALT or AST greater than 3 times upper limit of normal, Hb less than or equal to 8 g per dL or platelet count less than 100,000 per mm³, eGFR less than 60 mL/min/1.73 m²
- •Thyroid-stimulating hormone (TSH) levels outside the normal range for the institution.
- •Unstable angina, myocardial infarction, transient ischemic attack, or coronary interventions including coronary artery bypass surgery within 6 months prior to the consent date.
- •Acute stroke within 3 months prior to the consent date
- •Shift workers
- •Alcohol consumption exceeding WHO s daily intake guidelines greater than or equal to 40 g/day for men and greater than or equal to 20 g/day for women.
- •Heavy smokers (greater than or equal to 20 cigarettes/day)
- •Heavy use greater than 300 mg/day (greater than or equal to 3 cups coffee, energy drinks)
- •Pregnant, lactating, or planning pregnancy during the study period
- •Known hypersensitivity to any component of the investigational product
- •Participation in another clinical trial within 3 months prior to screening 20.
研究者
Dr Binu T Kuruvilla
Arjuna Natural Private Limited
研究点 (1)
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