Health Condition 1: F439- Reaction to severe stress, unspecified
Conditions
Interventions
None listed
Sponsors
Shree Divyanand Herbals
Eligibility
Inclusion criteria
Inclusion criteria: Subjects fulfilling all of the following criteria shall be considered eligible for inclusion in the study Age between eighteen and sixty five years inclusive of either sex Subjects with mild to moderate anxiety defined as Hamilton Anxiety Rating Scale score between eighteen and twenty four at the screening visit Subjects with elevated cortisol levels defined as cortisol level greater than or equal to thirteen micrograms per deciliter at the screening visit Subjects with poor sleep quality defined as Pittsburgh Sleep Quality Index score greater than five at the screening visit Subjects with Generalized Anxiety Disorder score between five and fourteen at the screening visit Subjects with Clinical Global Impression Severity score less than or equal to five at the screening visit Subjects who are able and willing to provide written informed consent Subjects who are willing and able to comply with all study procedures visit schedules and follow up assessments
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study Major psychiatric disorders eg major depressive disorder schizophrenia bipolar disorder Subjects meeting any of the following criteria shall be excluded from participation in the study Subjects with severe insomnia requiring pharmacological treatment Subjects with diagnosed sleep disorders including obstructive sleep apnea or narcolepsy Subjects with a history of controlled endocrine disorders including hyperthyroidism or Cushing syndrome Subjects with a history of serious hepatic or renal impairment defined as alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal or estimated glomerular filtration rate less than sixty milliliters per minute per one point seven three square meters Subjects currently using anxiolytics hypnotics sedatives or antidepressants Subjects undergoing ongoing psychotherapy or behavioural therapy for anxiety or sleep related disorders Subjects receiving ongoing psychotropic or hormonal medications during the study period Subjects who have participated in another clinical trial or used any investigational drug or device within three months prior to screening Subjects who are pregnant or lactating Women of childbearing potential who are not willing to use acceptable methods of contraception Subjects with a positive urine pregnancy test at screening or baseline Subjects with a history of hypersensitivity to Ashwagandha or any of the capsule ingredients Subjects with any condition which in the opinion of the investigator may interfere with study participation or pose an undue risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of Ashwagandha in reducing stress and anxiety scores using the Hamilton Anxiety Rating Scale (HAM-A).Timepoint: Baseline to (Day 45 1) and (Day 90 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess changes in serum cortisol levels To evaluate improvement in sleep quality using the Pittsburgh Sleep Quality Index To evaluate changes in anxiety symptoms using the Generalized Anxiety Disorder seven item scale To assess global improvement from the clinician perspective using the Clinical Global Impression Improvement scale To assess overall safety and tolerabilityTimepoint: Baseline to (Day 45 1) and (Day 90 1) | — |
Countries
India
Contacts
Public ContactBinay Kumar Naik
Indivirtus Global CRO PVT LTD
Outcome results
None listed