Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2018-07-30

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.

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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.

Conditions

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Frail Elderly Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel follow up of two treatment groups randomly allocated through a central randomization process

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

open label study

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk

Intervention Type DRUG

Polyherbal formulation along with standard of care

Standard of Care

Intervention Type 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.

Standard Care Group

Participants will only receive the standard of care treatment as determined by research physician

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type 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.

Interventions

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C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk

Polyherbal formulation along with standard of care

Intervention Type DRUG

Standard 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.

Intervention Type OTHER

Other Intervention Names

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Turmeric formula and Tulsi capsule and Milk

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes