Health Condition 1: Z733- Stress, not elsewhere classified
Conditions
Interventions
None listed
Sponsors
Central council for research in Ayurvedic Sciences Ministry of Ayush Government of India
Eligibility
Inclusion criteria
Inclusion criteria: i. Participants of any gender in the age group 18 to 60 years. ii. Participants scoring a score of 0-26 in Perceived Stress Scale (PSS). iii. Willing to provide informed written consent.
Exclusion criteria
Exclusion criteria: I.Participants with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl) II.History of cardiovascular, pulmonary, neurological, endocrine diseases or other concurrent severe disease. III.Lifetime history of psychotic disorders of any type, bipolar disorder, schizophrenia or schizoaffective disorder and other psychiatric disorders such as other anxiety disorders, major depressive disorder, IV.A diagnosis of any organic brain disease, mental retardation, or other cognitive dysfunction that could interfere with their capacity to participate in the study V.Participants on any psychotropic medications, mood stabilizers or benzodiazepines VI.History of alcohol or drug dependence. VII.History of uncontrolled diabetes (HbA1c > 8 %), Uncontrolled Hypertension (Resting blood pressure � 160 systolic and/or 100 diastolic) VIII.Participants with uncontrolled Hypothyroidism/ hyperthyroidism even with medication. IX.Participants with sub-clinical hypothyroidism (TSH 4.5 to 10 mIU/L) which require active therapy X.Pregnant / lactating women. XI.Participants who have completed participation in any other clinical trial during the past 3 months. XII.Any other condition which the investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i.Change in subjective stress assessed through Perceived Stress Scale (PSS).Timepoint: at baseline, 30th, 60th and 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| i.Change in sleep quality assessed through Pittsburgh Sleep Quality Index (PSQI) scale. ii.Change in Brief Resilience Scale (BRS). iii.Tolerability as measured by Occurrence of treatment emergent adverse events during the study period. Timepoint: i at Baseline,30th ,60th and 90th day. ii.at Baseline, 30th ,60th and 90th Day. iii.at baseline, 30th, 60th and 90th day. | — |
Countries
India
Contacts
Public ContactDr Sunita Mata
Central Council for research in Ayurvedic sciences
Outcome results
None listed