None listed
Conditions
Interventions
None listed
Sponsors
3H LABS Co. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female individuals aged from 20-75 (both inclusive) 2. Those with a Perceived Stress Scale within the range of 13 to 16 scores(both inclusive) 3. Those with Beck Anxiety Inventory within the range of 8 to 45 scores(both inclusive) 4. Those who voluntarily agree to participate and sign an informed consent form 5. Literate Subjects
Exclusion criteria
Exclusion criteria: 1. Those with a history of hypersensitivity to drugs or food ingredients 2. Those diagnosed with stress disorders per the DSM-V scale 3. Those who are night-shift workers or a person with two jobs which may cause chronic physical fatigue 4. Those who have been taking stress, anxiety, depression, antipsychotic related drugs, health-functional food, or herbal medicine within 3 months before screening 5. Those who have been taking hormonal therapies or medicines within 4 weeks before screening 6. Those who have undergone surgery within 6 months before screening 7. Those with a BMI of less than 18.5 kg/m2 or greater than 35 kg/m2 8. Those with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.), and endocrine disease (Cushing Syndrome) within the last 6 months (However, those who are clinically stable may participate in the trial at the investigator s discretion) 9. Those with a serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 3 times the upper limit of normal) or kidney (Serum creatinine greater than 2.0 mg/dL) 10. Those with mellitus diabetes or HbA1c greater than 7.0 percentage 11. Those with abnormal TSH level 12. Those with hypertension (blood pressure greater than or equal to 140/90mmHg) 13. Those with malignant tumors diagnosed within 3 years before screening 14. Those with eating disorders (anorexia, bulimia, etc.) who had or are planning on an intentional weight loss of at least 5 percentage within 3 months before screening 15. Those with a psychologically significant medical history or current disease (schizophrenia, epilepsy, etc.) or a history of alcohol or other drug abuse 16. Those pregnant or lactating, women of childbearing age who do not agree to use contraception during the trial. 17. According to the investigators opinion, those who are deemed unable to comply with the test requirements or otherwise deemed unsuitablee deemed unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from pre and post treatment on Perceived Stress Scale PSSTimepoint: Baseline, Week 4 and Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from pre- & post-treatment as assessed by Beck Anxiety Inventory (BAI)Timepoint: Baseline and Week 8;Changes from pre- & post-treatment as assessed by the Beck Depression InventoryTimepoint: Baseline and Week 8;Changes from pre- & post-treatment as assessed by Plasma ACTHTimepoint: Baseline and Week 8;Changes from pre- & post-treatment as assessed by Plasma CortisolTimepoint: Baseline and Week 8;Changes from pre- & post-treatment as assessed by Salivary alpha-AmylaseTimepoint: Baseline and Week 8;6.Changes from pre-& post-treatment as assessed by Plasma DHEA.Timepoint: Baseline and Week 8;7.Changes from pre- & post-treatment as assessed by Plasma TNF alphaTimepoint: Baseline and Week 8;8.Changes from pre- & post-treatment as assessed by Plasma Interleukins-6Timepoint: Baseline and Week 8;9.Changes from pre- & post-treatment as assessed by Plasma Interleukins-1 betaTimepoint: Baseline and Week 8 | — |
Countries
India
Contacts
Public ContactArabinda Patnaik
Syncorp Health Pvt. Ltd.
Outcome results
None listed