Clinical trial NCT03365310: Management of Frailty in Older Adults With Turmeric and Tulsi Supplements
Official title: Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frail Elderly Syndrome
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2017-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel follow up of two treatment groups randomly allocated through a central randomization process
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frailty Score
timeFrame: 3 months
Secondary outcomes:
measure: C reactive protein
timeFrame: 3 months
measure: Frequency of falls
timeFrame: 3 months
measure: Health service utilization
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Medical Centre
state: Karnataka
Study officials:
affiliation: Composite Interceptive Med Science
name: Dr. Sanjaya Chauhan
role: PRINCIPAL_INVESTIGATOR
affiliation: Narayana Hrudayalaya Hospital
name: Dr. Alben Sigamani
role: PRINCIPAL_INVESTIGATOR
References: