Auto-Immune DiseasesAlter-MAINCT04094259
Alternative Care in Patients With Auto-Immune Diseases
An observational study of Auto-Immune Diseases, run by University Hospital, Limoges at 1 site in France.
Trial summary
Patients followed in Internal Medicine bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auto-Immune Diseases
- What is being tested?
- Questionnaire.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 121 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2019to 1 Dec 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)
Who may be able to join
- Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)
- Patient with signed consent
Who cannot join
- Patients deprived of their liberty
- Minors and adults subject to legal protection measures
- Patients subject to a justice safeguard measure
- Patient unable to understand or adhere to the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proportion of the Use of Medicines and Alternative Care in Patients With Auto-Immune Diseases Alter-MAI
Patients followed in Internal Medicine bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with in the department of Internal Medicine A
Read the detailed description
Patients followed in Internal Medicine department bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with autoimmune diseases in the department of Internal Medicine .
At all times alternative medicine has existed. Internal Medicine deals with rare autoimmune diseases, of which there is not always a cure. Even when the treatment is optimal, there are often subjective complaints.Patients followed in Internal Medicine therefore have favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. This information will make it possible to target the patient's needs, and to be able to offer alternative medicines that are better focused, without calling into question their conventional treatment
- Conditions
- Auto-Immune Diseases
- Being tested
- Questionnaire.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire.Behavioural
patients will respond to a specific questionnaire regarding the use of alternative medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients using alternative medicine.
Counting the number of patients using alternative medicine.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start9 Sep 2019
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Auto-Immune DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094259
- Sponsor's protocol ID
- 87RI19-0020 (ALTER-MAI)
- Acronym
- Alter-MAI
- Status last verified
- Aug 2022
- First submitted
- 16 Sep 2019
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Couillard F, Parreau S, Dumonteil S, Ratti N, Palat S, Bezanahary H, Liozon E, Ly KH, Fauchais AL, Gondran G. Use of Complementary and Alternative Medicine by Patients Treated for Systemic Lupus Erythematosus, Primary Sjogren's Syndrome, or Systemic Sclerosis in a French Rural Region. Complement Med Res. 2024;31(3):234-240. doi: 10.1159/000536580. Epub 2024 Feb 12.
PubMed 38346411
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proportion of the Use of Medicines and Alternative Care in Patients With Auto-Immune Diseases Alter-MAI
- ClinicalTrials.gov ID
- NCT04094259
- Acronym / sponsor ID
- Alter-MAI / 87RI19-0020 (ALTER-MAI)
- Conditions
- Auto-Immune Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Sep 2019 (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.
Patients followed in Internal Medicine bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with in the department of Internal Medicine A
Detailed description
Patients followed in Internal Medicine department bring together favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. The main objective is the evaluation of the proportion of the use of alternative medicines in patients with autoimmune diseases in the department of Internal Medicine .
At all times alternative medicine has existed. Internal Medicine deals with rare autoimmune diseases, of which there is not always a cure. Even when the treatment is optimal, there are often subjective complaints.Patients followed in Internal Medicine therefore have favorable conditions for the use of alternative medicines. While some are recognized for their benefits, some can, on the contrary, harm the patient. It is therefore proposed to make a complete descriptive inventory of these practices, through an anonymized questionnaire. This information will make it possible to target the patient's needs, and to be able to offer alternative medicines that are better focused, without calling into question their conventional treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)
Key inclusion criteria (2 listed)
- Patient with systemic lupus erythematosus (ARA and/or SLICC criteria) OR with primary Sjögren's syndrome (revised Americano European criteria) OR with systemic scleroderma (ACR/EULAR 2012 criteria)
- Patient with signed consent
Key exclusion criteria (4 listed)
- Patients deprived of their liberty
- Minors and adults subject to legal protection measures
- Patients subject to a justice safeguard measure
- Patient unable to understand or adhere to the protocol
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 |
|---|---|---|
| Questionnaire.patients will respond to a specific questionnaire regarding the use of alternative medicine | Behavioural | – |
Primary outcome
The number of patients using alternative medicine.
Time frame: At day 1
Counting the number of patients using alternative medicine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 38346411Couillard F, Parreau S, Dumonteil S, Ratti N, Palat S, Bezanahary H, Liozon E, Ly KH, Fauchais AL, Gondran G. Use of Complementary and Alternative Medicine by Patients Treated for Systemic Lupus Erythematosus, Primary Sjogren's Syndrome, or Systemic Sclerosis in a French Rural Region. Complement Med Res. 2024;31(3):234-240. doi: 10.1159/000536580. Epub 2024 Feb 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auto-Immune Diseases, run by University Hospital, Limoges at 1 site in France.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 27 Mar 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients using alternative medicine. (time frame: At day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094259, which also lists 1 linked publication.
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 27 Mar 2026.