CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/04/083930 [Registered on: 02/04/2025] Trial Registered Prospectively

Last Modified On:

19/06/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Nutraceutical

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Effect of Rhodiola in elderly population

Scientific Title of Study

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.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
RHO/02/25, Version:1.0, Date: 05-02-2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr S N Meenakshi Sundari MBBS MD
Designation	Principal Investigator
Affiliation	SRM Medical College Hospital and Research Centre
Address	SRM Medical College Hospital and Research Centre, Dept. of General Medicine, SRM Nagar, Kattankulathur Kancheepuram TAMIL NADU 603203 India
Phone	9444249933
Fax
Email	dr.meenakshisundari@gmail.com

Details of Contact Person
Scientific Query

Name	Dr M Sakthi Balan MBBS MD
Designation	Consultant and CI
Affiliation	Ki3 PRIVATE LIMITED
Address	Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai Chennai TAMIL NADU 600032 India
Phone	9443627722
Fax
Email	saheerose@gmail.com

Details of Contact Person
Public Query

Name	Dr Gayathri Sivakumar
Designation	Director
Affiliation	Ki3 PRIVATE LIMITED
Address	Room No 1, Ki3 Office, Regus Centre Level 2, Altius Block No 1, SIDCO Industrial Estate, Chennai No 5 3, Dr Jayalakshmi Street, Radha Nagar, Chrompet, Chennai Chennai TAMIL NADU 600032 India
Phone	9003109416
Fax
Email	drgayathri@ki3services.com

Source of Monetary or Material Support

Finzelberg GmbH and Co. KG, Koblenzer Str 48-56 , 56626 Andernach, Germany, Tel.: 49 2632 924-00

Primary Sponsor

Name	Finzelberg GmbH and Co. KG,
Address	Koblenzer Str. 48-56 , 56626 Andernach, Germany, Tel.: 49 2632 924-00
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 4
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Yogesh S MBBS MD	Dr. Kennedys Saraswathy Multispeciality Hospital	Consultation Room, General Medicine, 92/a, bazaar main road, sastri nagar, madipakkam, Chennai, Tamil Nadu 600091 Chennai TAMIL NADU	9600128033 yeswhy20@gmail.com
Dr Yogesh S MBBS MD	Madras Medical College and Rajiv Gandhi Government General Hospital	Consultation room, Internal Medicine, GH Post Office, Poonamallee High Road, 3, Grand Southern Trunk Rd, near Park Town, Near Chennai Central, Park Town, Chennai, Tamil Nadu 600003 Chennai TAMIL NADU	9600128033 yeswhy20@gmail.com
Dr S N Meenakshi Sundari MBBS MD	SRM Medical College and Research Institute	Department of General Medicine, SRM Nagar, Kattankulathur, Chengalpattu Chennai TAMIL NADU	09444249933 dr.meenakshisundari@gmail.com
Dr V Sakthivel MBBS MD	Vinayaka missions Medical College and Hospital	Department of General Medicine, Keezhakasakudimedu,Kottucherry, Karaikal Karaikal PONDICHERRY	9842426095 hodmedicine@vmmckkl.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 4
Name of Committee	Approval Status
Madras Medical College	Approved
Oxymed Ethics Committee	Approved
SRM Medical College and Research Institute	Approved
Vinayaka Missions Medical College and hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: R54\|\|Age-related physical debility,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Placebo - microcrystalline cellulose	One capsule /day every morning after food.
Intervention	Rhodiola capsule 400mg	One capsule /day every morning after food.

Inclusion Criteria

Age From	55.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	1. Age and Gender Male and female participants aged 55 years and older For female, post menopause period (Participants with an absence of menstruation for more than one year during the screening period.) 2. Physical Inactivity Individuals who have not engaged in regular physical activity in the past 6 months, defined as: Less than 150 minutes of moderate intensity activity per week No resistance or strength training during this period. 3. Early Symptoms of Muscle Weakness or Muscle Mass Loss Documented mild to moderate muscle weakness or loss of muscle mass , confirmed by SARC F questionnaire (positive for sarcopenia risk, e.g., score greater than or equal to 4). Anthropometric measurements (e.g., reduced muscle circumference or muscle mass as assessed by BIA). 4. Fatigue and Limited Physical Performance Fatigue , defined by a score of greater than or equal to 4 on the Chalder Fatigue Scale Self-reported or objectively measured limitations in physical performance (e.g., gait speed less than 1 m/s in a 4 meter walking test)- 5. No Significant Weight Loss The criterion of weight loss of more than 5 percentage of total body weight is excluded to include participants without significant weight loss but with signs of muscle weakness over a period of 3 months, BMI of 18 – 35 both are inclusive and minimum body weight of 50kg. 6. Motivation for Participation in an Intervention Willingness and motivation to participate in a structured exercise program (e.g., documented through self-report or screening questionnaires). 7. Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.

ExclusionCriteria

Details

1. Participants with known history of a disease condition causing clinically significant fatigue or weight reduction or muscle loss (e.g. congestive cardiac failure, sleep disorders, chronic kidney disease, chronic infections, COPD, hepatitis, musculoskeletal dystrophies, cancer, diagnosed sarcopenia).
2. Hs CRP levels more than 3 mg/L
3. Currently taking medications that cause fatigue (e.g. diuretics, beta blockers, narcotics).
4. History of psychiatric disorder (e.g. major depressive disorder, bipolar disorder, anxiety disorder, schizophrenia, drug and/or addiction abuse or dependence).
5. History of smoking and alcohol consumption.
6. History of any medical condition that limits exercise performance for selected participants (e.g. any condition with a ventilatory limitation during maximal exercise and Rheumatoid arthritis).
7. Participants with uncontrolled diabetes mellitus (HbA1c greater than 10) and uncontrolled hypertension.
8. Active participation in any other similar study or having been participated in any study within 30 days.
9. History of consumption of any other nutritional supplement in the last 3 months. And/or current intake of corrective treatment, plant- based products or dietary supplements that could interfere in the study.
10. Known hypersensitivity to one of the components of the experimental products
11. Participants who have undergone any surgery within the past 6 months during screening

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome

TimePoints

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).
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

Outcome

TimePoints

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
3. To measure the Quality of life using SF 36 Questionnaire.
4. To evaluate the reduction in tiredness and fatigue measured with Chalder Fatigue Scale.
5. To evaluate the reduction in stress measured with perceived stress scale.
6. To evaluate the improvement in quality of sleep measured with Jenkins sleep scale.
7. To evaluate functional strength and balance with Single-Leg Balance Test
8. To evaluate the improvement in overall wellness measured with Perceived wellness survey.
9. To measure participants’ social engagement with Self-efficacy for Social Participation Scale (SOSA)
10. To evaluate the improvement in biomarkers (HsCRP, Testosterone levels) at Day 0 and week 12 only
11. Adverse event monitoring

Baseline, 8 weeks and 12 weeks

Target Sample Size

Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

11/04/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

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.