A Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha® Capsule (300 mg) in Management of Frailty in Older Adults

Ixoreal Biomed0 sites50 target enrollmentStarted: TBDLast updated: June 24, 2024

Study Overview

No summary available.

•1.Community-dwelling =60 years of age
•2.Patient who can and willing to provide written Informed Consent
•3.Patient with Frailty score of =7 based on FAST with normal cognition
•4.Patient with at high risk for mobility disability/ functional limitations as assessed by the investigator
•5.Patient able to independently ambulate
•6.Patient who has received medical clearance from the investigator
•7.Patient having capability of complete compliance and completion of follow-up
•8.Patient who agree to take investigational product (IP) till Day 56
•9.Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements

•1. Patient is currently under the inpatient-care of a geriatrician
•2. Patient with significant cognitive impairment/Severe mental disorder determined by the investigator
•3. Patient receiving palliative/end of life care/ life expectancy =6 months
•4. Patients with MMSE score = 20 points
•5. Patient having a history or presence of clinically significant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour.
•6. Patients with history of alcoholism or substance abuse.
•7. Patient who is not willing to take investigational product.
•8.Patient who had recent hospitalization for major illness or elective surgery within 1-year of the start date of study.
•9.Patient with any acute illness at the time of enrolment
•10.Patient who has participated in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements, 1 month prior to this trial
•11.Patient having an history of allergic reactions or anaphylaxis to investigational product components
•12.Any other condition which the principal investigator thinks may jeopardize the safety of subjects—patients with uncontrolled, unstable comorbidities
•13.Patients who had participated in other clinical trials during previous 3 months

Sponsor

Ixoreal Biomed