Study to assess the effect of multi-herb formulae and an Ashwagandha root formula on the stress and related symptoms
- Registration Number
- CTRI/2022/11/047635
- Lead Sponsor
- Vedic Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 186
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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