Effect of Ayush SR on psychological status and quality of life of the Elderly.

Phase 3

Completed

• Registration Number: CTRI/2022/06/043074
• Lead Sponsor: Ministry of Tribal Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-03-30
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

i.Apparently healthy elderly participants of age between 60 to 75 years of any sex,

ii.Participants who are clinically stable with or without medication

iii.Participants are willing to provide written informed consent for their participation in the study for 3 months.

iv.Participants scoring 5 or more in Katz Index of Independence in Activities of Daily Living

Exclusion Criteria

I.Known cases of uncontrolled Hypertension. (Average BP= 160/100 mm of Hg), uncontrolled Diabetes mellitus (HbA1c > 8%), uncontrolled Hypothyroidism with or without medication (S. TSH >10mIU/ml), severe cardiac dysfunction or Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit), renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),, Pulmonary Dysfunction (Asthmatic and COPD patients) and any severe cognitive or psychiatric illness, neurological disorders, hemorrhagic problems, coagulation, or bleeding issues within 90 days prior to the screening

II.Participants having body mass index (BMI) less than 22 or more than 32 kg/m2

III.Participants with a history of cancer or chronic inflammatory conditions, including but not limited to chronic infection like tuberculosis, leprosy, HIV, and collagen vascular diseases

IV.Participants on hormone replacement therapy, steroid therapy, chemotherapy, or immunosuppressive therapy

V.Participants with alcohol use disorder (AUD) (CAGE score >2)

VI.Any other condition that PI may think can jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in the Patient Health Questionnaire-9 (PHQ-9) score in both groups <br/ ><br>2.Change in Quality of life (QOL) of elderly assessed by Older People’s Quality of Life Questionnaire (OPQOL-35)Timepoint: 1.Time frame: Baseline, 30th day 60th day & 90th day <br/ ><br>2.

Secondary Outcome Measures

Name	Time	Method
1.Proportion of participants showing at least 5 point improvement in the score of Patient Health Questionnaire-9 in both groups <br/ ><br>2.Change in Quality of Sleep assessed by using the Pittsburgh Sleep Quality Index <br/ ><br>3.Change in the time required for Five Times Sit-to-Stand Test in both groups <br/ ><br>4.Change in the grading of shoulder joint mobility <br/ ><br>5.Any change in hematological and biochemical parameters <br/ ><br>6.Occurrence of treatment-emergent adverse events during the study periodTimepoint: 1.improvement in the score PHQ-9, in both groups(Baseline& 90th day) <br/ ><br>2.Change in PSQI (Baseline, 30th,60th & 90th day) <br/ ><br>3.Change in the time required for Five Times Sit-to-Stand Test in both groups (Baseline, 30th,60th & 90th day) <br/ ><br>4.Change in grading of shoulder joint mobility (Baseline, 30th,60th & 90th day) <br/ ><br>5.Any change in hematological and biochemical parameters(Baseline& 90th day) <br/ ><br> <br/ ><br>