NCT03365310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 7, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

29 days

First QC Date

December 2, 2017

Last Update Submit

April 10, 2018

Conditions

Frail Elderly Syndrome

Outcome Measures

Primary Outcomes (1)

  • Frailty Score

    To assess a change in frailty score from baseline in 3 months between two groups

    3 months

Secondary Outcomes (4)

  • C reactive protein

    3 months

  • Frequency of falls

    3 months

  • Health service utilization

    3 months

  • Mortality

    3 months

Study Arms (2)

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

Drug: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of MilkOther: Standard of Care

Standard Care Group

ACTIVE COMPARATOR

Participants will only receive the standard of care treatment as determined by research physician

Other: Standard of Care

Interventions

C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of MilkDRUG

Polyherbal formulation along with standard of care

Also known as: Turmeric formula and Tulsi capsule and Milk
Intervention Group
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.

Intervention GroupStandard Care Group

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, 560099, India

Location

MeSH Terms

Interventions

DiarylheptanoidsMilkholy basil leaf extractStandard of Care

Intervention Hierarchy (Ancestors)

HeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsHydrocarbons, AromaticHydrocarbons, CyclicBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Dr. Sanjaya Chauhan

    Composite Interceptive Med Science

    PRINCIPAL INVESTIGATOR

  • Dr. Alben Sigamani

    Narayana Hrudayalaya Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alben Sigamani

CONTACT

8884431444alben.sigamani.dr@nhhospitals.org

Sanjaya Chauhan

CONTACT

9611252350drsanjayachauhan49@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
open label study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel follow up of two treatment groups randomly allocated through a central randomization process
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2017

First Posted

December 7, 2017

Study Start

July 1, 2018

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

IN(1)