Frail Elderly Syndrome
Conditions
Brief summary
The aim of this study is to determine the efficacy of turmeric and tulsi polyherbal formulation in the management of frailty in the elderly population.
Detailed description
Frailty is a wasting syndrome of old age that leaves a person vulnerable to falls, functional decline, morbidity and mortality. Reducing the severity of frailty will provide large benefits for individuals, their families and for the society. It is assumed that early intervention with frail people will improve quality of life and reduce the costs of care. This trial is testing the frailty intervention with herbal medicine. If this frailty intervention is shown to be effective, there are major potential benefits to the frail older population generally in terms of decreased disability. The interventions being examined are readily transferable to routine clinical practice and can potentially be applied routinely in aged care services.
Interventions
DRUGC. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
Polyherbal formulation along with standard of care
OTHERStandard of Care
Usual standard of care for consist of exercise, caloric and protein support, vitamin D, reduction of polypharmacy along with medical management of health condition, assessment of care needs and provision of care. These will be determined on case by case basis by research clinician.
Sponsors
Composite Interceptive Med Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label study
Intervention model description
Parallel follow up of two treatment groups randomly allocated through a central randomization process
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects above the age of 65 years, providing written informed consent. * Meeting three or more Cardiovascular health study frailty criteria * Mild or no cognitive impairment (defined as a Mini-Mental State Examination score \>23), * Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention program
Exclusion criteria
People will be ineligible to participate in the trial if they: * Live in a residential aged care facility * Severe audio-visual impairment * Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc. * Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months * History of alcohol abuse or any other substance abuse * Severely affect muscle/joint dysfunction resulting in disability * Hospital admission in the past 3 months * Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week * Undergoing therapeutic diet incompatible with nutritional supplementation * In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frailty Score | 3 months | To assess a change in frailty score from baseline in 3 months between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C reactive protein | 3 months | Change in C-reactive Protein (CRP) from baseline |
| Frequency of falls | 3 months | defined as an event resulting in a person coming to rest unintentionally on the ground or other lower level; near-falls would not be included |
| Health service utilization | 3 months | frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission |
| Mortality | 3 months | Death of study participant during study period |
Countries
India
Contacts
Primary ContactAlben Sigamani
Backup ContactSanjaya Chauhan
Outcome results
None listed