None listed
Conditions
Interventions
Intervention1: Polyherbal supplementation along with an AI-based lifestyle intervention tool (mobile app): Morning Supplement Capsule A- 1 capsule in morning after breakfast for 60 days.
Night Supplem
Sponsors
Swiss Econaturals AG.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Females between the ages of 40-55 years (Both inclusive);2.Body Mass Index (BMI) between 19 and 30 kg/m²;3.No history of clinically relevant premenstrual syndrome (PMS);4.Willingness to complete questionnaires, records, and diaries associated with the study and to complete all visits;5.Provided voluntary, written informed consent to participate in the study;6.Participants should be willing to comply with the study protocol and follow prescribed lifestyle changes and supplementation regimens;7.Participants not consuming any health supplement and those willing to stop vitamin and other nutraceutical supplements and undergo washout period.
Exclusion criteria
Exclusion criteria: 1.Participants with a history of cardiovascular disease, including stroke, myocardial infarction, or unstable angina; 2.Participants with uncontrolled hypertension (systolic blood pressure greater than or equal to 140 mmHg or diastolic blood pressure greater than or equal to 90 mmHg); 3.Participants with diagnosed diabetes mellitus (fasting blood glucose greater than or equal to 126 mg/dL); 4.Participants with diagnosed thyroid disorders or endocrine disorders requiring ongoing treatment; 5.Participants with severe dyslipidemia (extremely elevated total cholesterol, LDL, triglycerides, or very low HDL levels); 6.Participants with a history of psychiatric disorders or conditions that may interfere with study participation or compliance; 7.Participants with chronic kidney disease or liver disease; 8.Participants with a history of or active cancer or undergoing cancer treatment; 9.Participants using medications or supplements that may interfere with the study interventions or assessments; 10.Participants who have participated in another clinical trial within the last 30 days; 11.Participants with known allergy or hypersensitivity to any components of the investigational products; 12.Pregnant and/or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Assessment of change in Perceived Stress Scale (PSS) scores from baseline to day 60. 2.Assessment of change in Insomnia Severity Index (ISI) scores from baseline to day 60Timepoint: At baseline, Day 7, Day 15, Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of change in Energy Audit Questionnaire scores at baseline and day 60. 2.Changes in Profile of Mood State (POMS) questionnaire score at screening and day 60. 3.Assessment of change in serum cortisol levels at screening and day 60. 4.Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia on screening, day 7, 15, 30 and 60. 5.Assessment of onset of sleep, sleep latency, total sleep time, and number of awakenings from sleep diary from baseline to end of study. Assessment of sleep quality by actigraphy in 5-10 subjects FitBit Watch. 6.Assessment of changes in metabolic health parameters from screening to day 60.Timepoint: From screening to end of the study | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
Mprex Healthcare Pvt. Ltd
Outcome results
None listed