Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03365310
Other study ID # OI-007-2017
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Completed NCT03271112 - Frailty Prevention in Elders From Reunion Island N/A
Recruiting NCT03141866 - Seated Physical Activity in Ageing N/A
Completed NCT03180606 - Enhanced Primary Care for Elderly
Recruiting NCT05940779 - Relationship Between the Risk of Falls and Frailty, and the Effect of a Physical Exercise Program on These Conditions in the Elderly: a Randomized Crossover Clinical Trial. N/A
Active, not recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Recruiting NCT04518423 - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Completed NCT03883425 - Frailty and Complexity Among Home Service Recipients
Recruiting NCT03657940 - Impact of a Multicomponent Exercise Program on Functional Capacity in Frail Aged Participants With Cognitive Decline N/A
Completed NCT03724461 - Effects of Resistance Training With High vs. Light-moderate Loads on Muscle-tendon Function in the Elderly N/A
Withdrawn NCT03176030 - Fortified Foods in Older Inpatients
Completed NCT04615533 - Validity Reliability of FrailBESTest in Older Adults
Recruiting NCT04238494 - Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study N/A
Active, not recruiting NCT06079762 - AGE SELF CARE: Promoting Healthy Aging Through a Group Visit Program N/A
Not yet recruiting NCT06019390 - eHealth for Screening Health Risks in Home-Based Older Adults: A Prospective Study N/A
Recruiting NCT03534765 - Frailty and Sarcopenia Outcomes in Emergency General Surgery
Active, not recruiting NCT03721471 - Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
Completed NCT03688932 - Effects of WBV Associated With IMT on Functionality N/A
Completed NCT03689322 - Effects of WBV Associated With IMT on Inflammatory Markers, Body Composition, Muscle Strength and Thickness N/A
Recruiting NCT03068299 - Effects of Music and Dance on Cognition, Frailty, and Burden in Elderly Caregivers Living in Rural Communities N/A