Frail Elderly SyndromeNCT03365310
Management of Frailty in Older Adults With Turmeric and Tulsi Supplements
A study testing C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk in people with Frail Elderly Syndrome, run by Composite Interceptive Med Science at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly Syndrome
- What is being tested?
- C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, 560099
Alben Sigamani, MD, 8884431444, alben.sigamani.dr@nhhospitals.org
Sanjaya Chauhan, Pharm.D, 9611252350, drsanjayachauhan49@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Frail Elderly Syndrome
- Being tested
- C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of MilkDrug
Also called Turmeric formula and Tulsi capsule and Milk
Polyherbal formulation along with standard of care
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk; Other: Standard of Care |
| Standard Care Group | Active comparator | Participants will only receive the standard of care treatment as determined by research physician Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Score
To assess a change in frailty score from baseline in 3 months between two groups
Measured: 3 months
Secondary outcomes (4)
C reactive protein
Change in C-reactive Protein (CRP) from baseline
Measured: 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
Measured: 3 months
Health service utilization
frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission
Measured: 3 months
Mortality
Death of study participant during study period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jul 2018 (estimated)
- Primary completion30 Jul 2018 (estimated)
- Study completion30 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel follow up of two treatment groups randomly allocated through a central randomization process
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Sanjaya Chauhan, Principal investigator, Composite Interceptive Med ScienceDr. Alben Sigamani, Principal investigator, Narayana Hrudayalaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365310
- Sponsor's protocol ID
- OI-007-2017
- Status last verified
- Apr 2018
- First submitted
- 2 Dec 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03365310
- Acronym / sponsor ID
- OI-007-2017
- Conditions
- Frail Elderly Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Jul 2018 (estimated)
- Study completion
- 30 Jul 2018 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel follow up of two treatment groups randomly allocated through a central randomization process
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk, Other: Standard of CareParticipants 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 |
| Standard Care Group | Active comparator | Other: Standard of CareParticipants will only receive the standard of care treatment as determined by research physician |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of MilkAlso: Turmeric formula and Tulsi capsule and MilkPolyherbal formulation along with standard of care | Drug | Intervention Group |
| Standard of CareUsual 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. | Other | Intervention Group, Standard Care Group |
Primary outcome
Frailty Score
Time frame: 3 months
To assess a change in frailty score from baseline in 3 months between two groups
4 secondary outcomes
C reactive protein
Time frame: 3 months
Frequency of falls
Time frame: 3 months
Health service utilization
Time frame: 3 months
Mortality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
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Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
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Feasibility and Effects of Inspiratory Muscle Training Combined With Blood Flow Restriction for Frail Older Adults
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Involvement of Muscle Mitochondrial Dysfunction in Frailty in Older Adults. Role of Exercise
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Sanjaya Chauhan principal investigator
Composite Interceptive Med Science
Dr. Alben Sigamani principal investigator
Narayana Hrudayalaya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk in people with Frail Elderly Syndrome, run by Composite Interceptive Med Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alben Sigamani (8884431444, alben.sigamani.dr@nhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.