CTRI/2022/05/042770已完成不适用
A prospective, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy of enXtra on mental alertness and fatigue in human subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Improvement in Mental Alertness
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, cross-over, clinical interventional study. Adult healthy males and/or females, aged between 18 and 55 years 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 will be obtained. The study is divided into Acute and Chronic phases with cross-over of treatment in both the phases. During the study , subjects will visit the sites 7 times over a period of 78 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive) 2.Subjects with Fatigue Severity Scale score >
- •3.Subjects with post-lunch sleepiness as indicated by Epworth sleepiness score ≥11 and ≤
- •4.Subjects with history of consuming <3 cups of tea/coffee per day.
- •5.Subjects who agree to sleep for 8 ± 1 hours the night before the visit day.
- •6.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
- •7.Subjects willing to refrain from taking any medications or preparations to improve fatigue (herbal, dietary supplements, homeopathic preparations, etc.) during the study.
- •8.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days.
- •9.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.
- •10.Subjects willing to refrain from vigorous physical activity 12 hours prior to visit days.
- •11.Subjects who agree to stay weight stable during the study period.
- •12.Female subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence: Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
- •OR Postmenopausal for at least 1 year.
- •OR Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the subject).
- •13.Subjects willing to provide written consent.
- •14.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.Having hypersensitivity or history of allergy to the study product.
- •2.Subjects with moderate to severe fatigue or having chronic fatigue syndrome.
- •3.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 4.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.
- •5.Subjects with a psychiatric diagnosis other than anxiety or depression.
- •7.Subjects with uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening.
- •8.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
- •9.Subjects with a history of drug and /or alcohol abuse at the time of enrolment.
- •10.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •11.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
- •12.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
- •13.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
Improvement in Mental Alertness
时间窗: Day 1, Day 7, Day 13, Day 40, Day 51, Day 78
次要结局
- Mean change in Fatigue and Energy(Day 1, Day 7, Day 13, Day 40, Day 51, Day 78)
- Mean Change in Vigor Scale(Day 1, Day 7, Day 13, Day 40, Day 51, Day 78)
- Mean change in Epworth Sleepiness Scale(Day 1, Day 7, Day 13, Day 40, Day 51, Day 78)
研究者
研究点 (1)
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