To understand the safety and effects of Ashwagandha in healthy adults with stress
- Registration Number
- CTRI/2024/03/063786
- Lead Sponsor
- OmniActive Health Technologies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline on stress as assessed by Perceived Stress ScaleTimepoint: Baseline and End of Study (Day 84)
- Secondary Outcome Measures
Name Time Method Mean change from baseline on stress biomarkers - serum cortisol levels, and salivary <br/ ><br>alpha-amylase <br/ ><br>Mean change from baseline on stress as assessed by Mindfield eSense Skin Response <br/ ><br>and Mindfield eSense PULSE - Heart Rate Variability <br/ ><br>Mean change from baseline on anxiety as assessed by Beck Anxiety Inventory <br/ ><br>Mean change from baseline on mood as assessed by Profile of Mood States <br/ ><br>Mean change from baseline on overall sleep quality as assessed by Pittsburgh Sleep <br/ ><br>Quality Index (PSQI) <br/ ><br>Mean change from baseline on safety as evaluated by hematology and biochemistry <br/ ><br>measures, adverse events, vital signs <br/ ><br>hair cortisol levelsTimepoint: Baseline and End of Study (Day 84)