Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Composite Interceptive Med Science

Status: Unknown

Conditions: Frail Elderly Syndrome

Treatments: Other: Standard of Care; Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk

Study type: Interventional

Funder types: Industry

Identifiers

NCT03365310

OI-007-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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

Treatment:

Other: Standard of Care

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

Standard Care Group

Active Comparator group

Description:

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

Treatment:

Other: Standard of Care