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Integrative MedicineEarly Phase 1NCT05141097

Integrative Medicine Quality of Life Study

A Early Phase 1 study testing Integrative medicine approach in people with Integrative Medicine, run by University of Arizona.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Integrative Medicine is an approach to health that addresses a person's mental, physical, social, spiritual, and environmental factors. Chronic diseases are best treated if the root cause is addressed, improving one's overall health. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Integrative Medicine
What is being tested?
Integrative medicine approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 30 Aug 2022
Phase
Early Phase 1
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • The inclusion criteria are any healthy or non-healthy adult or child
  • English-speaking
  • Any ethnic background
  • Any socioeconomic status

Who cannot join

  • Pregnant women

About this study

Official title: Quality of Life for Patients Who Are Treated Using Integrative Medicine

Integrative Medicine is an approach to health that addresses a person's mental, physical, social, spiritual, and environmental factors. Chronic diseases are best treated if the root cause is addressed, improving one's overall health. Health is defined by the WHO as "a state of complete physical, mental and social wellbeing, and not merely the absence of disease or infirmity." Many national institutions, such as the American Heart Association, American College of Cardiology, American Diabetes Association, and more, all affirm that lifestyle modifications are the number one treatment and prevention for the most common disorders: high blood pressure, obesity, diabetes, high cholesterol, etc. The generic term "lifestyle modifications" encompasses many aspects that can be impacted by Integrative Medicine.

Patients present to be treated by Integrative Medicine practitioners frequently, and we would like to see how their quality of life is improving by being treated by this practice approach.

Read the detailed description

At the turn of the 19th century, medicine made great strides in the field of bacteriology. Development of antibiotics, pasteurization, sterilization and antiseptic techniques led to tremendous advances in the understanding of disease pathophysiology.

Unfortunately, with increased longevity came increased rates of chronic diseases, a shift referred to as the "epidemiological transition." Lifestyle risk factors have been directly linked to the increase in diseases, such as heart disease, cancer, and stroke - with these conditions overtaking infectious diseases such as TB, influenza, cholera, and pneumonia as the major sources of mortality in the developed countries.

These major external or modifiable factors contributing to US mortality were subsequently labeled the "actual causes of death" and included tobacco usage, physical inactivity, diet, alcohol, sexual behaviors, and others (McGinnis, 1993). This same analysis has persisted into the 21st century. An analysis by Mokdad published in JAMA, 2004 found that tobacco, poor diet, physical inactivity and alcohol use were the leading causes of death, collectively accounting for 36.8% of all deaths in 2000. In 2014, chronic diseases remain the leading cause of mortality and morbidity in the US and the main contributors to these diseases are tobacco use, poor diet, physical inactivity, alcohol use, hypertension and hyperlipidemia - all modifiable risk factors. As medical research shifted toward addressing these chronic health conditions linked to lifestyle risk factors, the clinical practice of medicine shifted to a disease-oriented model.

At the core of Integrative Medicine, physicia strive to delineate factors that have caused a person to be who they are at this current stage, all the way from when they were in utero until now.

Integrative Medicine is a practice approach to medicine that strives to achieve health, the definition of health being a state of complete physical, mental and social wellbeing, and not merely the absence of disease or infirmity, as defined by the WHO.

The Andrew Weil Center of Integrative Medicine has the following principals at the core of its practice: the patient and practitioner are partners in the healing process; all factors that influence health, wellness and disease are taken into consideration, including mind, spirit and community, as well as the body. Appropriate use of both conventional and alternative methods facilitates the body's innate healing response. Effective interventions that are natural and less invasive should be used whenever possible; the broader concepts of health promotion and prevention of illness are paramount.

Being tested
Integrative medicine approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrative medicine approachOther

    By treated by integrative medicine approaches instead of conventional medicine

Study groups in NCT05141097
Study groupRoleWhat they receive
TreatmentExperimentalBeing cared for by an Integrative Medicine provider
Receives: Other: Integrative medicine approach
ControlNo interventionBeing cared for by conventional medicine provider

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medical Symptoms Questionnaire

    Quantitative review of systems survey, with a maximum score of 280 indicating severe toxicity, and a minimum score of 0 indicating no toxicity. The score breakdown is as following: <10 optimal health, 10-50 mild toxicity, 50-100 moderate toxicity, >100 severe toxicity.

    Measured: through study completion, anticipated 6 months

  2. PROMIS Global Health Scale

    Qualitative quality of life survey, with a maximum score of 45 indicating great subjective quality of life, and minimum score of 0 indicating very poor subjective quality of life.

    Measured: through study completion, anticipated 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05141097
Sponsor's protocol ID
aahmed2
Status last verified
Nov 2021
First submitted
6 Nov 2021
Last updated
2 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Integrative medicine approach in people with Integrative Medicine, run by University of Arizona.

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 1 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 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medical Symptoms Questionnaire (time frame: through study completion, anticipated 6 months). The study lists 2 primary outcomes in all. 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 2 Dec 2021.

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