None listed
Conditions
Interventions
None listed
Sponsors
Ministry of Tribal Affairs
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the Patient Health Questionnaire-9 (PHQ-9) score in both groups 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 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of participants showing at least 5 point improvement in the score of Patient Health Questionnaire-9 in both groups 2.Change in Quality of Sleep assessed by using the Pittsburgh Sleep Quality Index 3.Change in the time required for Five Times Sit-to-Stand Test in both groups 4.Change in the grading of shoulder joint mobility 5.Any change in hematological and biochemical parameters 6.Occurrence of treatment-emergent adverse events during the study periodTimepoint: 1.improvement in the score PHQ-9, in both groups(Baseline& 90th day) 2.Change in PSQI (Baseline, 30th,60th & 90th day) 3.Change in the time required for Five Times Sit-to-Stand Test in both groups (Baseline, 30th,60th & 90th day) 4.Change in grading of shoulder joint mobility (Baseline, 30th,60th & 90th day) 5.Any change in hematological and biochemical parameters(Baseline& 90th day) | — |
Countries
India
Contacts
Public ContactDrKalpana Kachare
Central Council for Research in Ayurvedic Sciences, Ministry of Ayush
Outcome results
None listed