Back to resultsManagement of Frailty in Older Adults With Turmeric and Tulsi Supplements
Primary Purpose
Frail Elderly Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Frail Elderly Syndrome
Eligibility Criteria
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.
Sites / Locations
- Mazumdar Shaw Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Standard Care Group
Arm Description
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
Participants will only receive the standard of care treatment as determined by research physician
Outcomes
Primary Outcome Measures
Frailty Score
To assess a change in frailty score from baseline in 3 months between two groups
Secondary Outcome Measures
C reactive protein
Change in C-reactive Protein (CRP) from baseline
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
Health service utilization
frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission
Mortality
Death of study participant during study period
Full Information
NCT ID
NCT03365310
First Posted
December 2, 2017
Last Updated
April 10, 2018
Sponsor
Composite Interceptive Med Science
1. Study Identification
Unique Protocol Identification Number
NCT03365310
Brief Title
Management of Frailty in Older Adults With Turmeric and Tulsi Supplements
Official Title
Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Composite Interceptive Med Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel follow up of two treatment groups randomly allocated through a central randomization process
Masking
None (Open Label)
Masking Description
open label study
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
Standard Care Group
Arm Type
Active Comparator
Arm Description
Participants will only receive the standard of care treatment as determined by research physician
Intervention Type
Drug
Intervention Name(s)
C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
Other Intervention Name(s)
Turmeric formula and Tulsi capsule and Milk
Intervention Description
Polyherbal formulation along with standard of care
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frailty Score
Description
To assess a change in frailty score from baseline in 3 months between two groups
Time Frame
3 months
Secondary Outcome Measure Information:
Title
C reactive protein
Description
Change in C-reactive Protein (CRP) from baseline
Time Frame
3 months
Title
Frequency of falls
Description
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
Time Frame
3 months
Title
Health service utilization
Description
frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission
Time Frame
3 months
Title
Mortality
Description
Death of study participant during study period
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alben Sigamani
Phone
8884431444
Email
alben.sigamani.dr@nhhospitals.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjaya Chauhan
Phone
9611252350
Email
drsanjayachauhan49@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Sanjaya Chauhan
Organizational Affiliation
Composite Interceptive Med Science
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Alben Sigamani
Organizational Affiliation
Narayana Hrudayalaya Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mazumdar Shaw Medical Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alben Sigamani, MD
Phone
8884431444
Email
alben.sigamani.dr@nhhospitals.org
First Name & Middle Initial & Last Name & Degree
Sanjaya Chauhan, Pharm.D
Phone
9611252350
Email
drsanjayachauhan49@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Management of Frailty in Older Adults With Turmeric and Tulsi Supplements
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