None listed
Conditions
Interventions
Intervention1: Zenroot 125 mg Capsules: Subjects will be instructed to consume one capsule every morning after breakfast, at the same time every day, for 84 days (12 weeks).
Control Intervention1: Mi
Sponsors
OmniActive Health Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stressed male or female adults aged between 18 to 55 years (both limits inclusive). 2. BMI of 18.5 kg/m2 to 29.9 kg/m2 (both limits inclusive). 3. Subjects with mild to moderate stress as determined by a score =7 or =26 on the PSS. 4. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period. 5. Subjects willing to refrain from taking any medications or preparations for addressing stress or anxiety or mood (herbal, dietary supplements, homeopathic preparations, etc.) during the study. 6. Subjects willing to refrain from consuming alcohol 24 hours prior to the test days. 7. Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to test days 8. Subjects willing to refrain from vigorous physical activity 12 hours prior to test days. 9. Subjects who agree to stay weight stable during the study period. 10. Subjects who agree to have a minimum 7–8-hour sleep before the visit days and during the study period. 11. 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). 12. Subjects willing to provide written consent. 13. 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.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. 2. 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 3. Subjects with a psychiatric diagnosis including anxiety or depression 4. Subjects with sleep disturbances and/or are taking sleep aid medication 5. Subjects having hypersensitivity or history of allergy to the study product 6. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications 7. Subjects with a history of drug and /or alcohol abuse at the time of enrolment 8. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period 9. Subjects with positive Urine Pregnancy Test prior randomization 10. Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry 11. Subjects with severe stress based on PSS score greater than 26 12. Subjects with uncontrolled hypertension -systolic blood pressure greater 160 mm Hg or diastolic blood pressure greater 100 mm Hg at screening 13. Excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater than or equal to 3 cups of caffeinated coffee/day) throughout the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline on stress as assessed by Perceived Stress ScaleTimepoint: Baseline and End of Study (Day 84) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline on stress biomarkers - serum cortisol levels, and salivary alpha-amylase Mean change from baseline on stress as assessed by Mindfield eSense Skin Response and Mindfield eSense PULSE - Heart Rate Variability Mean change from baseline on anxiety as assessed by Beck Anxiety Inventory Mean change from baseline on mood as assessed by Profile of Mood States Mean change from baseline on overall sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) Mean change from baseline on safety as evaluated by hematology and biochemistry measures, adverse events, vital signs hair cortisol levelsTimepoint: Baseline and End of Study (Day 84) | — |
Countries
India
Contacts
Public ContactT Vijaya Bhaskar
Invitro Research Solutions Pvt. Ltd
Outcome results
None listed