Effectiveness of Ayurveda regimen on Quality of Life of elderly populatio

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

i.Elderly population of any sex, of age =60 to =75 years residing in the identified areas.

ii.Participants who are ambulatory and clinically stable with or without medication

iii.Participants 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.Participants with blood pressure = 160/100 mm of Hg),

ii.Participants with HBA1C = 8 %

iii.Participants with S. TSH >10 mIU/ml with or without medication, elevated liver enzymes (AST and/or ALT > 2 times of the upper normal limit), impairment of renal function (defined as S. creatinine > upper normal limit),

iv.Participants with history of serious cardiac dysfunction or Pulmonary Dysfunction (Asthmatic and COPD patients), any severe cognitive or psychiatric illness, neurological disorders, hemorrhagic diseases, coagulation disorders within 90 days prior to the screening

v.Participants having body mass index (BMI) less than 23 or more than 30 kg/m2

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

vii.Participants on Hormone Replacement Therapy, steroid therapy, chemotherapy or immunosuppressive therapy

viii.Participants with alcohol use disorder (AUD) (CAGE score >2) (Annexure III)

ix.Participants who are currently on any drugs that affect cognitive or physical function or on any nutritional supplements or any Ayush or folk medicine for maintaining quality of life

x.Any other condition which 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 Quality of life (QOL) of elderly assessed by Older People’s Quality of Life Questionnaire- Brief (OPQOL-BRIEF)Timepoint: Baseline, 34th day, 62nd day & 90th day <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Change in Katz Index of Independence in Activities of Daily LivingTimepoint: Time frame: Baseline & 90th day;2.Change in Quality of Sleep assessed by using Pittsburgh Sleep Quality Index (PSQI)Timepoint: Time frame: Baseline & 90th day;3.Change in the time required for Five Times Sit-to-Stand Test in bothTimepoint: Time frame: Baseline & 90th day;4.Change in grading of shoulder joint mobility assessed through 3 simple physical manoeuvres for active ROM of the shoulder joints (Active abduction, external rotation & internal rotation)Timepoint: Time frame: Baseline & 90th day;5.Any change in hematological & bio-chemical parameters (CBC, LFT and RFT)Timepoint: Time frame: Baseline & 90th day;6.Occurrence of treatment emergent adverse events during the study periodTimepoint: any time day 1to 90th day