Study of herbal mixture supplement in reducing stress and improving energy levels in middle-aged women.

Phase 2

Not yet recruiting

• Registration Number: CTRI/2024/06/069224
• Lead Sponsor: Swiss Econaturals AG.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.Participantswithknownallergyor hypersensitivityto any components of the investigational products;

12.Pregnant and/or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified