A clinical study to see the Rasayana effect of an Ayurvedic formulation in the Elderly.

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. Apparently Healthy Males / Females of age between 50 and 75 years

2. Willing and able to participate for 16 weeks

Exclusion Criteria

1. Patients with evidence of malignancy

2. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)

3. Patients who have a past history of Atrial Fibrillation, Coronary Artery Disease (CAD), Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

4. Symptomatic patient with clinical evidence of Heart failure.

5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)

6. Patients on prolonged ( > 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

7. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL).

8. Patients with severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), Inflammatory Bowel Disease, Severe Dementia, Severe Infection(s), Non-ambulatory patient or any other condition that may jeopardize the study.

9. Prostate Specific Antigen (PSA) levels > 4 ng/mL

10. Alcoholics and/or drug abusers.

11. Pregnant / lactating woman

12 Patients suffering from Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% or HbA1c > 6.5%}.

13 H/o hypersensitivity to the trial drug or any of its ingredients.

14 Patients who have completed participation in any other clinical trial during the past six (06) months.

15 Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â?¢ Change in the clinical symptoms (using the Visual Analogue Scale). <br/ ><br>â?¢ Change in Quality of life using WHO-QOL-BREFTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. <br/ ><br>WHO-QOL-BREF is assessed only at Baseline, 84th day and at the end of follow up after 16 weeks.

Secondary Outcome Measures

Name	Time	Method
â?¢ Change in Hamilton Depression Rating Scale Score <br/ ><br>â?¢ Change in PGI Memory Scale <br/ ><br>â?¢ Change in the Laboratory parameters (markers for ageing). <br/ ><br>o ESR <br/ ><br>o IL-6 <br/ ><br>o Serum Cortisol <br/ ><br>o Serum Cholesterol <br/ ><br>o High Density Lipoprotein (HDLc) <br/ ><br>o Low Density Lipoprotein (LDLc) <br/ ><br>o hs CRP <br/ ><br>o TSHTimepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week. <br/ ><br>The laboratory parameters are assessed at Baseline and on 84th day.