Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 108 for:    Turmeric extract | Turmeric

Management of Frailty in Older Adults With Turmeric and Tulsi Supplements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03365310
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Composite Interceptive Med Science

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.

Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk Other: Standard of Care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk
Polyherbal formulation along with standard of care
Other Name: Turmeric formula and Tulsi capsule and Milk

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.

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




Primary Outcome Measures :
  1. Frailty Score [ Time Frame: 3 months ]
    To assess a change in frailty score from baseline in 3 months between two groups


Secondary Outcome Measures :
  1. C reactive protein [ Time Frame: 3 months ]
    Change in C-reactive Protein (CRP) from baseline

  2. 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

  3. Health service utilization [ Time Frame: 3 months ]
    frequencies of doctor visits, emergency room visit, hospitalization, nursing home admission

  4. Mortality [ Time Frame: 3 months ]
    Death of study participant during study period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365310


Contacts
Layout table for location contacts
Contact: Alben Sigamani 8884431444 alben.sigamani.dr@nhhospitals.org
Contact: Sanjaya Chauhan 9611252350 drsanjayachauhan49@gmail.com

Locations
Layout table for location information
India
Mazumdar Shaw Medical Centre Not yet recruiting
Bangalore, Karnataka, India, 560099
Contact: Alben Sigamani, MD    8884431444    alben.sigamani.dr@nhhospitals.org   
Contact: Sanjaya Chauhan, Pharm.D    9611252350    drsanjayachauhan49@gmail.com   
Sponsors and Collaborators
Composite Interceptive Med Science
Investigators
Layout table for investigator information
Principal Investigator: Dr. Sanjaya Chauhan Composite Interceptive Med Science
Principal Investigator: Dr. Alben Sigamani Narayana Hrudayalaya Hospital

Layout table for additonal information
Responsible Party: Composite Interceptive Med Science
ClinicalTrials.gov Identifier: NCT03365310     History of Changes
Other Study ID Numbers: OI-007-2017
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs