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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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 |
|
| Standard Care Group | Active Comparator | Participants will only receive the standard of care treatment as determined by research physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk | Drug | Polyherbal formulation along with standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frailty Score | To assess a change in frailty score from baseline in 3 months between two groups | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
People will be ineligible to participate in the trial if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alben Sigamani | Contact | 8884431444 | alben.sigamani.dr@nhhospitals.org | |
| Sanjaya Chauhan | Contact | 9611252350 | drsanjayachauhan49@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Sanjaya Chauhan | Composite Interceptive Med Science | Principal Investigator |
| Dr. Alben Sigamani | Narayana Hrudayalaya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mazumdar Shaw Medical Centre | Bangalore | Karnataka | 560099 | India |
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| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D008892 | Milk |
| C000713370 | holy basil leaf extract |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
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Parallel follow up of two treatment groups randomly allocated through a central randomization process
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open label study
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| Standard of Care | Other | 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. |
|
| 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 |
| D009930 |
| Organic Chemicals |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |