Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alben Sigamani; Phone Number: 8884431444; Email: alben.sigamani.dr@nhhospitals.org
• Study Contact Backup: Name: Sanjaya Chauhan; Phone Number: 9611252350; Email: drsanjayachauhan49@gmail.com

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560099
      • Mazumdar Shaw Medical Centre
      • Contact: Alben Sigamani, MD; Phone Number: 8884431444; Email: alben.sigamani.dr@nhhospitals.org
      • Contact: Sanjaya Chauhan, Pharm.D; Phone Number: 9611252350; Email: drsanjayachauhan49@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 88 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk; Polyherbal formulation along with standard of care; Other Names: Turmeric formula and Tulsi capsule and Milk; Other: 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.
Active Comparator: Standard Care Group; Participants will only receive the standard of care treatment as determined by research physician	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty Score	To assess a change in frailty score from baseline in 3 months between two groups	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Composite Interceptive Med Science
• Investigators: Principal Investigator: Dr. Sanjaya Chauhan, Composite Interceptive Med Science

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): July 30, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: December 2, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2018
• Last Update Submitted That Met QC Criteria: April 10, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: OI-007-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No