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.
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.
- Conditions
- Integrative Medicine
- 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 group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Being cared for by an Integrative Medicine provider Receives: Other: Integrative medicine approach |
| Control | No intervention | Being cared for by conventional medicine provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted2 Dec 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrative MedicineStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ambereen Ahmed, University of Arizona
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life for Patients Who Are Treated Using Integrative Medicine
- ClinicalTrials.gov ID
- NCT05141097
- Acronym / sponsor ID
- aahmed2
- Conditions
- Integrative Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 2 Dec 2021 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Integrative medicine approachBeing cared for by an Integrative Medicine provider |
| Control | No intervention | –Being cared for by conventional medicine provider |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- The inclusion criteria are any healthy or non-healthy adult or child
- English-speaking
- Any ethnic background
- Any socioeconomic status
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| Integrative medicine approachBy treated by integrative medicine approaches instead of conventional medicine | Other | Treatment |
Primary outcome
Medical Symptoms Questionnaire
Time frame: through study completion, anticipated 6 months
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.
PROMIS Global Health Scale
Time frame: through study completion, anticipated 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.