Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Not Applicable

• Conditions: Frail Elderly Syndrome
• Interventions: Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk; Other: Standard of Care

• Registration Number: NCT03365310
• Lead Sponsor: Composite Interceptive Med Science

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.

Study Timeline

• Study First Submitted: 2017-12-02
• Study First Submitted QC: 2017-12-02
• Study First Posted: 2017-12-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11
• Study Start: 2018-07-01
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk	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
Intervention Group	Standard of Care	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	Standard of Care	Participants will only receive the standard of care treatment as determined by research physician

Primary Outcome Measures

Name	Time	Method
Frailty Score	3 months	To assess a change in frailty score from baseline in 3 months between two groups

Secondary Outcome Measures

Name	Time	Method
Mortality	3 months	Death of study participant during study period
Health service utilization	3 months	frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission
C reactive protein	3 months	Change in C-reactive Protein (CRP) from baseline
Frequency of falls	3 months	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

Trial Locations

Locations (1)

Mazumdar Shaw Medical Centre; 🇮🇳 Bangalore, Karnataka, India