Evaluation of effect of Ayush SR in Perceived stress

Phase 3

• Conditions: Health Condition 1: Z733- Stress, not elsewhere classified

• Registration Number: CTRI/2022/07/043667
• Lead Sponsor: Central council for research in Ayurvedic Sciences Ministry of Ayush Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
i.Change in subjective stress assessed through Perceived Stress Scale (PSS).Timepoint: at baseline, 30th, 60th and 90th day <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
i.Change in sleep quality assessed through Pittsburgh Sleep Quality Index (PSQI) scale. <br/ ><br>ii.Change in Brief Resilience Scale (BRS). <br/ ><br>iii.Tolerability as measured by Occurrence of treatment emergent adverse events during the study period. <br/ ><br>Timepoint: i at Baseline,30th ,60th and 90th day. <br/ ><br>ii.at Baseline, 30th ,60th and 90th Day. <br/ ><br>iii.at baseline, 30th, 60th and 90th day. <br/ ><br>