A Randomized, Double-Blinded, Placebo-Controlled Clinical Study to evaluate the Safety and Efficacy of Rhodiola in Enhancing Physical, Mental and social wellbeing, in Physically Inactive elderly Adults.

This randomized double-blind placebo-controlled parallel clinical study will enroll 140 physically inactive adults aged 55 to 75 years into two equal groups of 70 participants each with an equal gender distribution. The study will span 15 months post-CTRI approval with each participant undergoing a 12-week intervention.

Inclusion Criteria: Eligible participants must be physically inactive with less than 150 minutes per week of moderate-intensity activity and no resistance training, postmenopausal for females, and exhibit early symptoms of muscle weakness with a SARC-F score of 4 or more and reduced muscle mass via BIA. Fatigue defined by a Chalder Fatigue Scale score of 4 or more, limited physical performance with gait speed less than 1 meter per second, BMI between 18 and 35, and a body weight of at least 50 kilograms are required.

Exclusion Criteria: Conditions causing fatigue, muscle loss, or weight reduction such as congestive cardiac failure, chronic kidney disease, cancer, and COPD, hs-CRP greater than 3 milligrams per liter, psychiatric disorders, smoking, alcohol use, uncontrolled diabetes with HbA1c greater than 10, and recent supplement use, surgery, or clinical study participation.

Endpoints: Primary outcomes include muscle mass, strength measured through grip test, bench press, leg press, and appendicular skeletal muscle mass index, and endurance measured through a six-minute walk and sit-stand test. Secondary endpoints assess lean body mass, VO2 max, quality of life using SF-36, fatigue using the Chalder Fatigue Scale, stress using the Perceived Stress Scale, sleep using the Jenkins Sleep Scale, balance using the Single-Leg Test, wellness using the Perceived Wellness Survey, social engagement using the Self-Efficacy for Social Participation Scale, and biomarkers including hsCRP and testosterone. Safety assessments include vitals, ECG, and blood parameters.