None listed
Conditions
Interventions
None listed
Sponsors
Ixoreal Biomed
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the mean change of Frailty Score (FAST- Frailty Assessment and Screening Tool) between active and placebo groupsTimepoint: Baseline and Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in 6-MIN walk test between baseline and Day 56 2.Assessment of PSQI (Pittsburgh Sleep Quality Index) between groups 3.change in (CRP, CORTISOL, CREATININE Kinase) levels between groups 4.Assessment of Memory and Cognition level using MMSE questionnaire 5.Assessment of SF 12 (QoL) between the groups. Timepoint: Baseline and Day 56 | — |
Countries
India
Contacts
Public ContactMr Sohal Pendse
ProRelix Services LLP
Outcome results
None listed