None listed
Conditions
Interventions
Intervention1: VL-G-A57: Dose: 700mg daily
Route: Oral
Regimen: 2 capsules in the morning with food and 2 capsules in the evening with food
Duration: 60 days
Intervention2: VL-G-E12: Dose: 700 mg dai
Sponsors
Vedic Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female subjects =18 and = 65 years’ old with active lifestyle, moderate physical activity level as per International Physical Activity Questionnaire – Short Form (IPAQ - SF) 2 BMI: 18 to 29.9 kg/m2 3 RSQ-W (Restorative Sleep Questionnaire-weekly version) score less than or equal to 50 4 PSS scores ranging from 27-40 5 All participants will be encouraged to not make any major lifestyle changes during the study period. 6 They will be informed that any major changes may result in exclusion from the study. 7 Participants willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1 Subjects with a medical history of heart disease, respiratory disorders, metabolic or lifestyle disorders, seizure disorders, or other chronic health conditions requiring medication were excluded. 2 Individuals who currently, or in the past 6 months suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 5.0.01) or were taking a psychotropic medication or other herbal preparation were also excluded from participating in the study. 3 Subjects with a blood pressure range of systolic = 140 mm Hg and diastolic = 90 mm Hg. 4 Subjects on any sleep medication since last 3 months 5 Subjects with a history of severe intrinsic sleep related disorders. 6 Subjects who have taken Ashwagandha or any sleep or other supplements within the last three months, 7 People with a known hypersensitivity to Ashwagandha 8 Subjects who work on a night shift 9 Nursing or pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the impact of the Investigational Product (IP) on stress levels by using the Perceived stress scale (PSS)from baseline.Timepoint: Day 0, Day 30 and Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess change in the total score of the restorative sleep questionnaire weeklyTimepoint: Day 0, Day 30 and Day 60;To assess changes in Adrenocorticotropic Hormone (ACTH) in plasmaTimepoint: Day 0, Day 30, and Day 60;To assess changes in morning Salivary CortisolTimepoint: Day 0, Day 30 and Day 60;To assess sleep quality using Pittsburgh Sleep Quality Index.Timepoint: Day 0, Day 30 and Day 60;To assess the impact of IP on Fatigue using the Fatigue Severity ScaleTimepoint: Day 0, Day 30 and Day 60;To assess the impact of the IP on the Mental alertness of the participants using a three-pointer scale after risingTimepoint: Day 0, Day 30 and Day 60;To assess the impact of the IP on total scores of Depression, Anxiety, Stress Scale-21Timepoint: Day 0, Day 30 and Day 60 | — |
Countries
India
Contacts
Public ContactZubair Ansari
Vedic Lifesciences Pvt Ltd
Outcome results
None listed