A clinical trial to study the effects of 2 Ayurvedic formulations, containing Ashwagandha, Brahmi and Amalaki on the physical and emotional well-being of elderly subjects

INTERVENTION: Intervention1: Tablet containing Hydro‐alcoholic extract of Withania somnifera 150 mg and Bacopa monniera 50mg: 500 mg BD for 6 months Intervention2: Tablet PHP‐ Ageing containing hydro‐alcoholic extracts of Withania somnifera 150mg and Phyllanthus emblica 200 mg: 500 mg BD for 6 months Control Intervention1: Tablet Placebo: 500 mg BD for 6 months CONDITION: Quality of Life in elderly subjects PRIMARY OUTCOME: The primary outcome measures will be 10% improvement in the QOL score over and above that obtained in the group receiving placebo, 10% improvement in the symptom score over and above that obtained in the group receiving placebo and less than 10% difference in adverse events (including laboratory variables) between placebo and active treatment groups.‐‐‐‐‐‐Timepoint: SECONDARY OUTCOME: Not Applicable‐‐‐‐‐‐Timepoint: INCLUSION CRITERIA: Individuals satisfying all the following criteria will be included in the study 1. Individuals between the age group of 65 ‐ 75years of either sex 2. Those who fit into either Grades 1 or 2 on the Objective physical health scale (as described below) Objective physical health: Grade 1: without any irreversible illness Grade 2: minor irreversible illness that is neither life shortening nor disabling (e.g., treatable glaucoma, controlled primary hypertension, non‐crippling arthritis, controlled diabetes on oral anti‐diabetic agents) Grade 3: irreversible life‐threatening illness (e.g., coronary thrombosis or diabetic patients on insulin) Grade 4: irreversible illness with significant disability (e.g. multiple sclerosis, chronic congestive heart failure).1 3. Individuals ready to abide by trial procedures and to give informed consent.