Effect of Rhodiola in elderly population

Phase 3

Not yet recruiting

• Conditions: Age-related physical debility,

• Registration Number: CTRI/2025/04/083930
• Lead Sponsor: Finzelberg GmbH and Co. KG,

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-19
• Study Start: 2025-11-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of Rhodiola on muscle mass (Anthropometry and BMI), muscle strength (Hand grip test), Bench Press, Leg Press, DOMS (Delayed onset muscle soreness) and Appendicular Skeletal Muscle Mass Index (ASMI).	Baseline, 8 weeks and 12 weeks
To evaluate the improvement in energy levels by measuring gait speed, chair stand test, Walking Capacity, measured as distance or speed, tested via a 6-minute walk test and 30-second sit-stand.	Baseline, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
1. To measure Lean Body Mass (LBM)	2. To evaluate the improvement in energy levels by measuring VO2 max through Treadmill test for those participants who will be able to do Treadmill test

Trial Locations

Locations (4)

Dr. Kennedys Saraswathy Multispeciality Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Madras Medical College and Rajiv Gandhi Government General Hospital; 🇮🇳 Chennai, TAMIL NADU, India

SRM Medical College and Research Institute; 🇮🇳 Chennai, TAMIL NADU, India

Vinayaka missions Medical College and Hospital; 🇮🇳 Karaikal, PONDICHERRY, India

Dr. Kennedys Saraswathy Multispeciality Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr Yogesh S MBBS MD

Principal investigator

9600128033

yeswhy20@gmail.com