Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial

Conditions
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Frail Elderly Syndrome

Intervention / Treatment
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* Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel follow up of two treatment groups randomly allocated through a central randomization process
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Participants will receive turmeric and tulsi capsule with milk(100 ml) along with standard of care treatment as determined by research physician...Each participants has to take two capsules of turmeric formula and tulsi twice daily for the study period of 3 months | Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk<br>* Polyherbal formulation along with standard of care<br>* Other names: Turmeric formula and Tulsi capsule and Milk;Other: Standard of Care<br>* 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.<br>|
| Active Comparator: Standard Care Group<br>Participants will only receive the standard of care treatment as determined by research physician | Other: Standard of Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty Score | To assess a change in frailty score from baseline in 3 months between two groups | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein | Change in C-reactive Protein (CRP) from baseline | 3 months | 
| Frequency of falls | 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 | 3 months | 
| Health service utilization | frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission | 3 months | 
| Mortality | Death of study participant during study period | 3 months |