An interventional study of C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk and Standard of Care in Frail Elderly Syndrome, sponsored by Composite Interceptive Med Science. Status unknown at 1 site in India. Open to participants aged 65 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by Composite Interceptive Med Science · Not applicable, Interventional, and Treatment
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.
Composite Interceptive Med Science is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
People will be ineligible to participate in the trial if they:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Other: Standard of Care
Participants will only receive the standard of care treatment as determined by research physician
Other: Standard of Care
Polyherbal formulation along with standard of care
Also known as: Turmeric formula and Tulsi capsule and Milk
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.
Frailty Score
To assess a change in frailty score from baseline in 3 months between two groups
Time frame: 3 months
C reactive protein
Change in C-reactive Protein (CRP) from baseline
Time frame: 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
Time frame: 3 months
Health service utilization
frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission
Time frame: 3 months
Mortality
Death of study participant during study period
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Composite Interceptive Med Science