CTRI/2025/07/091775
尚未招募
3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Pinorox® (Pine Bark Extract) Capsule (Group I: Test) Compared to Placebo Capsule (Group II: Reference) for Cognitive Impairment in subjects impaired by aging.
Ambe Phytoextracts Pvt Ltd2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2025年8月11日最近更新:
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Ambe Phytoextracts Pvt Ltd
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in cognitive function as measured by the Mini Mental State Examination (MMSE) score and CANTAB (Cambridge Neuropsychological Test Automated Battery) assessments.
概览
简要总结
A randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study designed to evaluate the efficacy and safety of Pinorox® (Pine Bark Extract) 100 mg capsules compared to placebo in subjects with age-related cognitive impairment.The study will be conducted over approximately 180 days at a minimum of two sites in India. It includes six scheduled visits during which participants will undergo periodic assessments to evaluate cognitive function using tools such as MSME, CANTAB, and relevant biomarkers.Safety will be monitored through routine laboratory tests and the documentation of any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects aged, fifty to eighty years inclusive, with a body mass index ranging from 18.5 to 29.9 kilograms per square meter inclusive.
- •2.Subjects with complaints of cognitive decline.
- •3.Subjects who have a Mini Mental State Examination score between eighteen and twenty three inclusive.
- •4.Subjects and or legally acceptable representative who provide written informed consent to participate in the study.
- •5.Subjects who have the ability to comprehend the full nature and purpose of the study including possible risks and adverse events the ability to cooperate with the investigator and comply with the entire study requirements.
- •6.Subjects who are willing to use appropriate birth control methods throughout the duration of the study.
排除标准
- •1.Subjects with psychiatric disorders (other than mild to moderate depression or anxiety with score greater than five on GDS SF with known neuropsychiatric conditions like Schizophrenia, Alzheimer’s disease (AD) or Parkinsons’s disease; Epilepsy, Mental retardation, Huntington’s disease, Picks disease etc.
- •2.Subjects who meet the definition of dementia according to the Diagnostic and Statistical Manual of Mental Disorders V.
- •3.Subjects who had the following medications within four weeks prior to the consent date (i.e., Medications used to treat Dementia, Brain Metabolism enhancers, Central nervous system stimulants, Antipsychotics, Anticholinergics, Anticoagulants, Tricyclic Antidepressants, Anxiolytics, Nootropics, etc.).
- •4.Subjects who have taken health supplements related to the study function within three months prior to the start of the study.
- •5.Subjects with abnormal laboratory findings Alanine aminotransferase or aspartate aminotransferase levels are greater than three times the upper limit of normal, hemoglobin is less than or equal to 8.5g per deciliter or platelet count is less than one hundred thousand per cubic millimeter, and estimated glomerular filtration rate is less than sixty milliliters per minute per 1.73 meters square.
- •6.Subjects with cognitive impairment due to brain disease or mental illness.
- •7.Subjects with uncontrolled hypertension Systolic Blood Pressure greater than 140 mmHg or Diastolic Blood Pressure greater than 90 mmHg at the time of screening, or those whose hypertension is not controlled with stable medication for at least three months.
- •8.Subjects with uncontrolled diabetes (i.e., Random blood sugar greater than 200 milligram per deciliter at the time of screening or those whose diabetes is not controlled with stable medication for at least three months.
- •9.Subjects with thyroid-stimulating hormone levels outside the normal range.
- •10.Subjects with a history of unstable angina, myocardial infarction, transient ischemic attack, or coronary artery interventions, including coronary artery bypass surgery, inflammatory or rheumatologic disease, cerebrovascular incident, chronic hepatic disease, within six months prior to the consent date.
结局指标
主要结局
Change in cognitive function as measured by the Mini Mental State Examination (MMSE) score and CANTAB (Cambridge Neuropsychological Test Automated Battery) assessments.
时间窗: MMSE: Baseline (Day 1), Week 6, Week 12, Week 18, and Week 24 | CANTAB: Baseline (Day 1), Week 12, and Week 24
次要结局
- Change in Sleep Quality(– Assessed using the Sleep Quality Scale (SQS))
研究者
Shaji Paulose
Vimta Labs Limited
研究点 (2)
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