None listed
Conditions
Interventions
Intervention1: enXtra, 300 mg Capsule: A single day single dose of 300mg enXtra in Acute phase and single dose of 300mg enXtra for 28 days during Chronic Phase
Control Intervention1: Placebo 300mg
Sponsors
OmniActive Health Technologies
Eligibility
Inclusion criteria
Inclusion criteria: 1.BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive) 2.Subjects with Fatigue Severity Scale score >4. 3.Subjects with post-lunch sleepiness as indicated by Epworth sleepiness score =11 and =17. 4.Subjects with history of consuming 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.
Exclusion criteria
Exclusion criteria: 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. 6.Subjects with sleep disturbances and/or are taking sleep aid medication. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Mental AlertnessTimepoint: Day 1, Day 7, Day 13, Day 40, Day 51, Day 78 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Epworth Sleepiness ScaleTimepoint: Day 1, Day 7, Day 13, Day 40, Day 51, Day 78;Mean change in Fatigue and EnergyTimepoint: Day 1, Day 7, Day 13, Day 40, Day 51, Day 78;Mean Change in Vigor ScaleTimepoint: Day 1, Day 7, Day 13, Day 40, Day 51, Day 78 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed