CTRI/2024/09/074472尚未招募不适用
A Prospective, Randomized, Double-Blind, 4-Arm, Parallel Group, Active-Controlled Study to Evaluate The Efficacy of MA2/24 in Comparison with Caffeine on Mood, Energy, Focus,Attention and Fatigue in Healthy Working-Class Subjects.
Akay Natural Ingredients Private Limited,1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年9月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Effect of BF-24 arms compared to placebo in Cognitive Performance
研究概览
简要总结
This is a randomized, double-blind, active-controlled, 4-treatment arms, parallel group, clinical interventional study. Adult healthy males and/or females, working professionals, aged between 35 and 65 years old and meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. After the informed consent process, demographic details such as date of birth, sex, ethnicity and race will be obtained. Medical history including hypertension, diabetes mellitus, chronic liver, gastrointestinal and renal disorders, surgeries, any other clinically significant medical and medication history including dementia will be obtained. Subjects found eligible for study participation will be randomized into one of the 4 treatment arms (1:1:1:1) as per randomization schedule for a treatment period of 28 days. The study will be conducted over 6 visits on baseline, day 1, 3, 7, 14 and 28 and tests for cognitive assessments will be performed.
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
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects who are working-class professionals 2.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive) 3.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
- •4.Subjects willing to refrain from taking any medications or preparations to improve fatigue (herbal, dietary supplements, homeopathic preparations, etc.) during the study.
- •5.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days.
- •6.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.
- •7.Subjects willing to refrain from vigorous physical activity 12 hours prior to visit days.
- •8.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 9.Having basic computer literacy and exposure to computerized tests.
- •10.Must be willing and able to give informed consent and comply with the study procedures.
- •11.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Consumption of any cognition, energy and mood improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines.
- •2.Having hypersensitivity or history of allergy to the study product.
- •3.Subjects with moderate to severe fatigue or having chronic fatigue syndrome.
- •4.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection 5.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
- •6.Subjects with a psychiatric diagnosis other than anxiety or depression.
- •7.Subjects with sleep disturbances and or are taking sleep aid medication.
- •8.Subjects with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening.
- •9.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications.
- •10.Subjects with a history of drug and or alcohol abuse at the time of enrolment.
- •11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •12.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
- •13.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
- •14.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Effect of BF-24 arms compared to placebo in Cognitive Performance
时间窗: Day 1, Day 3, Day 7, Day 14, Day 28
次要结局
- Effect of BF-24 arms on Blood Biomarkers(Day 1, Day 3, Day 7, Day 14, Day 28)
- Overall Safety(Day 1, Day 3, Day 7, Day 14, Day 28)
研究者
Dr Mohan ME
BGS Global Institute of Medical Sciences
研究点 (1)
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