Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
Green Chem
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and Female healthy adult subjects ranging in age from 18 to 54 years. 2.Adults Subjects willing to provide a written Informed Consent 3.Free of psychiatric conditions other than mild stress 4.Could read and write English.
Exclusion criteria
Exclusion criteria: 1.Subjects with insomnia, sleep disorders, or chronic stress 2.Chronic alcoholics (more than 2 standard pegs / day) 3.Subjects with known Hypertension and other diseases of the cardiovascular system 4.Subjects with known Liver diseases, Kidney diseases, Psychiatric diseases, Epilepsy and/or with any other relevant diseases 5.Subjects with the intention of non-compliance to the study-protocol 6.Subject participating in another clinical trial or has received any IP within 90 days prior to Visit 1 (Screening). 7.Retraction of the written informed consent 8.Subjects currently taking medications other than oral contraceptive pill 9.Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc. 10.Pregnant, attempting to conceive, or lactating women 11.Individuals with acute narrow-angle glaucoma, prostate hypertrophy, cardiovascular, endocrine or renal disease, or another chronic disease that could affect stress/anxiety or restrict normal, daily function were also ineligible to participate in the study. 12.Individuals who currently, or in the past 6 months, suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 6.0) or were taking a psychotropic medication or other herbal preparation were also excluded from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline - Sleep analysis by using Acti WatchTimepoint: Baseline, Day 14 and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study in Athens Insomnia ScaleTimepoint: Screening, Baseline, Day 14, 28, & 56;Change from baseline to the end of the study in Hs CRPTimepoint: Baseline, Day 14 and Day 56;Change from baseline to the end of the study in Perceived Stress ScaleTimepoint: Screening, Baseline, Day 14, 28, & 56;Change from baseline to the end of the study in Serum CortisolTimepoint: Baseline, Day 14 and Day 56;To assess the Safety and Tolerability of IPTimepoint: Baseline and Day 56 | — |
Countries
India
Contacts
Public ContactAbhinav Shukla
Ayurlife health solutions
Outcome results
None listed