Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Frail Elderly Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365310
• Other study ID #: OI-007-2017
• Status: Not yet recruiting
• Phase: N/A
• First received: December 2, 2017
• Last updated: April 10, 2018
• Start date: July 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2018
• Source: Organic India
• Contact: Alben Sigamani
• Phone: 8884431444
• Email: alben.sigamani.dr[@]nhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly Syndrome

Intervention

Drug:
• C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
Polyherbal formulation along with standard of care

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.

Locations

Country	Name	City	State
India	Mazumdar Shaw Medical Centre	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty Score	To assess a change in frailty score from baseline in 3 months between two groups	3 months
Secondary	C reactive protein	Change in C-reactive Protein (CRP) from baseline	3 months
Secondary	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
Secondary	Health service utilization	frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission	3 months
Secondary	Mortality	Death of study participant during study period	3 months