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EVALUATION OF AYUSH-SR TABLET IN OCCUPATIONAL STRESS AMONG NURSES

Phase 3
Conditions
Health Condition 1: Z566- Other physical and mental strain related to work
Registration Number
CTRI/2020/07/026276
Lead Sponsor
Central Council for Research in Ayurvedic Sciences Ministry of AYUSH Government of India
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

a.Nursing professionals with a work experience of more than 1 year, working at Dr. RML Hospital, New Delhi.

b.Subjects who are willing to participate in the clinical trial and signing the informed consent form.

c.Subjects of either sex in the age group 25 â?? 50 years irrespective of socioeconomic status.

d. Subjects fulfilling the diagnostic criteria â?? Professional Life Stress Scale score above 15 and below 46 (16-45).

e. Subjects not on any psychotropic or other drugs for at least four weeks prior to entering the study

Exclusion Criteria

a.Nurses suffering from other psychiatric disorders and using psychiatric therapy.

b. Nurses who are known cases of major systemic illness.

c.Women who are planning to conceive, Pregnant or lactating women.

d.H/o hypersensitivity to any of the trial drugs or their ingredients.

e. Nurses with Hypothyroidism and Hyperthyroidism.

f. Nurses 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 > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.

g.Diabetic patients with HbA1c value above 8

h.Nurses whose blood pressure is: systolic above 160 mm of Hg and diastolic more than 100 mmHg.

i. Nurses who have completed participation in any other clinical trial during the past 3 months.

j.Any other condition which the investigator thinks may jeopardize the subject and/or study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assessment of change in scores of PLSS (Professional Life Stress Scale)Timepoint: After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day.
Secondary Outcome Measures
NameTimeMethod
1.Assessment of the clinical safety of Ayurvedic intervention AYUSH-SR, in the management of Occupational stress. <br/ ><br>2.Changes in the scores of WHOQOL-BREF (Quality of Life) <br/ ><br>3.Changes in the scores of Manasa Bhava factors <br/ ><br>Timepoint: After enrollment on day 1 and assessment will be done on 30th, 60th and 90th day.
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