Prospective, Randomized, Double-Blind, Placebo controlled Human Clinical Study using SanAshwa
Table: Mean Demographic data of the study subjects
|Supplement Groups||Female||Male||Total subject in each Supplement group|
INCLUSION CRITERIA: The subjects were included based on following criteria
- Male or female, age 18 -50 years
- 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 index14
- Standard safety biology.
EXCLUSION CRITERIA: The subjects were excluded based on following criteria
- Any current ongoing medical illness
- Neurologic or psychiatric pathology,
- Consumption of psychotropic
- High level of caffeine consumption
- Any important chronic pathology
- Drugs which impairs concentration, anxiety and stress
- HAD-A results above 12 and below 4
TOTAL TREATMENT DAYS: 28 Days
SERVINGS PER DAY: 2 Capsules – One after breakfast and one after dinner
- Evaluation of changes in the Serum Cortisol levels from Screening to EOT
- Evaluation of the changes in Stress sub-scale of Depression Anxiety and Stress Scale-21 (DASS-21) from Screening to EOT
- Evaluation of the changes in the7-item sub-scale measuring symptoms of stress.
- Evaluation of the changes in the Patient Health Questionnaire-9 (PHQ-9) from Screening and EOT
- Evaluation of the changes in the Generalized Anxiety Disorder-7 (GAD-7)
- The safety and tolerability were assessed by observation and by volunteered reports from the patients. Adverse events were documented with the concomitant medications.
The data was analyzed with 5% significance level and 80 % power for study using SAS. The difference between the groups was assessed using paired t-test for Serum Cortisol levels and Wilcoxon Rank Sum Test was used to assess difference between the groups for rest of the parameters.
Ethical Conduct of the study
The study was initiated after written approval from Institutional Ethics Committee and also after registration of this trial in CTRI. The trial was conducted as per the ICMR Guidelines for Biomedical Research on Human subjects, ICH GCP Guidelines, Schedule Y, Declaration of Helsinki (Brazil, 2013) and in accordance with other applicable guidelines.