Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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
  • Active Comparator: Standard Care Group
    • Participants will only receive the standard of care treatment as determined by research physician

Clinical Trial Outcome Measures

Primary Measures

  • Frailty Score
    • Time Frame: 3 months
    • To assess a change in frailty score from baseline in 3 months between two groups

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Composite Interceptive Med Science
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Sanjaya Chauhan, Principal Investigator, Composite Interceptive Med Science
    • Dr. Alben Sigamani, Principal Investigator, Narayana Hrudayalaya Hospital
  • Overall Contact(s)
    • Alben Sigamani, 8884431444, alben.sigamani.dr@nhhospitals.org

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