None listed
Conditions
Interventions
Intervention1: Zenroot Ashwagandha 125 mg capsules: Subjects will be instructed to
consume one capsule every
morning after breakfast, at the
same time every day, for 56
days (8 weeks).
Control Interve
Sponsors
OmniActive Health Technologies
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects must have a BMI of 18.5 to 29.9 kilograms per square meter (both limits inclusive). 2. Subjects with moderate stress as determined by a score greater than or equal to fourteen and less than or equal to twenty-six on the PSS. 3. Subjects with morning (8-9 AM) serum cortisol levels of greater than twenty micrograms per deciliter. 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 who agree to refrain from consuming alcohol 24 hours prior to the visit days. 7. Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days. 8. Subjects willing to refrain from vigorous physical activity/ strenuous exercise 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 hours 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 having hypersensitivity or history of allergy to the study product. 2. Subjects with severe stress based on PSS score. 3. Subjects experiencing stress for more than 6 months prior to the date of screening 4. 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. 5. 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. 6. Subjects with a psychiatric diagnosis including anxiety or depression. 7. Subjects with sleep disturbances and/or are taking sleep aid medication. 8. Subjects with uncontrolled hypertension (SBP greater than 160 mmHg or DBP greater than 100 mmHg) at screening. 9. Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications. 10. Excessive habitual caffeine consumption More than 300 mg of caffeine per day or greater than or equal to 3 cups of caffeinated coffee per day) throughout the study period. 11. Subjects with a history of drug and /or alcohol abuse at the time of enrolment. 12. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 13. Subjects with positive Urine Pregnancy Test at Screening /Randomization Visit. 14. Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry. 15. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in serum cortisol levelsTimepoint: Baseline, Day 14, Day 28, Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in stress, anxiety, mood, overall sleep quality and safetyTimepoint: Baseline, Day 14, Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed