None listed
Conditions
Interventions
Intervention1: SanAshwa Capsule: oral, One Capsule Twice in a Day for 28 days
Control Intervention1: Placebo: oral, One Capsule Twice In a Day for 28 days
Sponsors
Sandhu Products Inc
Eligibility
Inclusion criteria
Inclusion criteria: •Healthy volunteers who are willing to give informed consent •Healthy volunteers who are able to comply with the study requirements •anxiety and depression score equal or below 12 and above 4 •Subjects with WHO-5 wellbeing index 14 •Standard safety biology •Subjects who are facing routine work stresses along with anxiety
Exclusion criteria
Exclusion criteria: •Pregnancy •Any current ongoing medical illness •HAD A results above 12 and below 4 •HAD D results above 12 •Neurologic or psychiatric pathology •Consumption of psychotropic •High level of caffeine consumption •Any important chronic pathology •Drugs which impairs concentration, anxiety and stress •Subjects who are having positive serology
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| â?¢The safety and tolerability were assessed by observation and by volunteered reports from the patients. Adverse events were documented with the concomitant medicationsTimepoint: Screening to End of treatment | — |
Primary
| Measure | Time frame |
|---|---|
| â?¢Evaluation of the changes in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21) â?¢Evaluation of the changes in the 7-item sub-scale measuring symptoms of stress. â?¢Evaluation of the changes in the Patient Health Questionnaire-9 (PHQ-9) â?¢Evaluation of the changes in the Generalized Anxiety Disorder-7 (GAD- 7) â?¢Evaluation of changes in the cortisol levelsTimepoint: Screening to End of treatment | — |
Countries
India
Contacts
Public ContactDr Harisha S
ICBio Clinical research Pvt Ltd
Outcome results
None listed