Chronic DiseaseMinervaNCT07040475
Effects of the Clinical Application of Traditional, Complementary and Integrative Medicine (TCIM) Procedures During Inpatient Stays in Germany
An observational study of Chronic Disease, run by Charite University, Berlin, Germany at 3 sites in Germany.
Trial summary
The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Inpatient TCIM therapy
- How many people
- 2,500 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients in TCIM wards are offered the opportunity to participate in this study.
Who may be able to join
- Beginning (first 24 hours) inpatient TCIM treatment at Immanuel Hospital Berlin, Bamberg Hospital, or Evangelische Kliniken Essen-Mitte
- Written consent form
Who cannot join
- Insufficient language skills
- Dementia or other severely impairing cognitive disorders
- Pregnancy or breastfeeding
- Participation in a clinical study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Holger Cramer, Prof. Dr. contact
Germany3 sites, 3 recruiting
- Recruiting
Sozialstiftung Bamberg, Klinikum Bamberg
Bamberg, 96049
Jost Langhorst, Prof. Dr.
- Recruiting
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
Berlin, 14109
Miriam Rösner, Study nurse, 00493080505682, m.roesner@immanuel.de
- Recruiting
Klinik für Naturheilkunde und Integrative Medizin, KEM
Essen, 45276
Marc Werner, Dr.
About this study
Official title: Effects of the Clinical Application of TCIM Procedures During Inpatient Stays in Germany - a Multicenter Observational Study
The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Kliniken Essen-Mitte, where inpatient TCIM therapies are to be systematically evaluated. This form of therapy, which is reimbursed by statutory health insurance providers (under certain conditions), is based on a combination of various evidence-based TCIM approaches. These include hyperthermia, exercise therapy, Mind-Body Medicine, phytotherapy, nutritional therapy, fasting therapy inter alia.
- Conditions
- Chronic Disease
- Being tested
- Inpatient TCIM therapy
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient TCIM therapyOther
This multicenter, prospective, uncontrolled observational study is evaluating the effects and safety of inpatient TCIM therapy (German: naturheilkundliche Komplextherapie) at three German clinics: Immanuel Hospital Berlin, Klinikum Bamberg, and Evangelical Clinics Essen-Mitte. This therapy, reimbursed by statutory health insurance under certain conditions, combines evidence-informed TCIM approaches such as hyperthermia, exercise therapy, phytotherapy, and dietary interventions including fasting i.a.
| Study group | Role | What they receive |
|---|---|---|
| TCIM | Not described Receives: Other: Inpatient TCIM therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Health Survey - 12 Items (SF-12)
0-100, higher scores indicate better health status.
Measured: Baseline, 3 months
Secondary outcomes (50)
Short Form Health Survey - 12 Items (SF-12)
0-100, higher scores indicate better health status.
Measured: Baseline, up to 14 days, 6 months, 12 months
EuroQol 5-Dimension 5-Level
0 (worst) to 1 (best), higher scores indicate better health-related quality of life.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Food Frequency List
Descriptive measure; not scored on a numeric scale.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
International Physical Activity Questionnaire - Short Form
MET-min/week (variable), higher scores indicate higher physical activity levels.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Hospital Anxiety and Depression Scale
0-21 per subscale (Anxiety and Depression), higher scores indicate more severe symptoms.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Work Productivity and Activity Impairment Questionnaire
0%-100%, higher scores indicate greater impairment (i.e., worse outcome).
Measured: Baseline, 3 months, 6 months, 12 months
Perceived Stress Scale - 4
0-16, higher scores indicate higher perceived stress.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Main complaint
Visual Analog Scale (0-100, higher scores mean a worse outcome)
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Fibromyalgia Impact Questionnaire
0-100, higher scores indicate greater impact of fibromyalgia (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Rheumatoid Arthritis Disease Activity Index
0-10, higher scores indicate greater disease activity (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Bath Ankylosing Spondylitis Disease Activity Index
0-10, higher scores indicate more active disease (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Bath Ankylosing Spondylitis Functional Index
0-10, higher scores indicate more functional limitation (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Western Ontario and McMaster Universities Osteoarthritis Index
0-100, higher scores indicate greater pain/stiffness/disability (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Irritable Bowel Syndrome Symptom Severity Score
0-500, higher scores indicate more severe IBS symptoms (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Short Inflammatory Bowel Disease Questionnaire
10-70, higher scores indicate better quality of life.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Pain Disability Index
0-70, higher scores indicate greater disability (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Roland Morris Disability Questionnaire
0-24, higher scores indicate more severe disability (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Maslach Burnout Inventory
Variable by subscale (Emotional Exhaustion: 0-54, Depersonalization: 0-30, Personal Accomplishment: 0-48) Higher scores on EE/DP = worse outcome; higher PA = better outcome.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Beck Depression Inventory-II
0-63, higher scores indicate more severe depressive symptoms (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Diabetes Distress Scale - 2
1-6, higher scores indicate greater emotional distress related to diabetes (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Dermatology Life Quality Index
0-30, higher scores indicate greater impact on quality of life (worse outcome).
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Functional Assessment of Cancer Therapy - General
0-108, higher scores indicate better quality of life.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Use of the healthcare system
Descriptive data (e.g., number of visits); not a scored scale.
Measured: Baseline,12 months
Expectations regarding inpatient TCIM treatment
5-point Likert scale, 1-5. Higher scores indicate stronger or more positive expectations.
Measured: Baseline
Chalder Fatigue Scale
0-33, higher scores mean a worse outcome
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Somatic Symptom Scale
0-32, higher scores mean a worse outcome
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Body weight [kg]
Measured: Baseline, up to 14 days
Height [in cm]
Measured: Baseline
BMI [kg/m2]
Measured: Baseline, up to 14 days
Systolic blood pressure [mmHg], diastolic blood pressure [mmHg]
Measured: Baseline, up to 14 days
Waist circumference [in cm]
Measured: Baseline, up to 14 days
Triglycerides [mg/dl]
Measured: Baseline, up to 14 days
Total cholesterol [mg/dl]
Measured: Baseline, up to 14 days
HDL [mg/dl]
Measured: Baseline, up to 14 days
LDL [mg/dl]
Measured: Baseline, up to 14 days
Glucose [mg/dl]
Measured: Baseline, up to 14 days
Uric acid [μmol/L]
Measured: Baseline, up to 14 days
Creatinine [mg/dl]
Measured: Baseline, up to 14 days
CRP [mg/l]
Measured: Baseline, up to 14 days
GPT [U/l]
Measured: Baseline, up to 14 days
HbA1c [mmol/mol]
Measured: Baseline, up to 14 days
HbA1c [%]
Measured: Baseline, up to 14 days
Headache Impact Test (HIT-6)
36-78. A higher value indicates a greater impairment due to headaches.
Measured: Baseline, up to 14 days, 3 months, 6 months, 12 months
Integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)
The integrity of the intestinal barrier is tested via CLE during routine esophagogastro-duodenoscopy to detect primary or secondary (food-induced) barrier defects.
By CLE, the intestinal mucosa and the epithelial lining can be analyzed in vivo with a 1000 x magnification. An intestinal barrier defect can be detected by the leakage of a contrast agent (fluorescein) from the blood vessels through the intestinal epithelial spaces into the intestinal cavity and the shedding of epithelial cells.
Measured: Baseline, within 3 to 12 months
Result of the esophagogastro-duodenoscopy
Participants undergo an esophagogastro- duodenoscopy with CLE when clinically indicated as part of their inpatient care. Thereby, the inflammatory status and the intestinal barrier is routinely analyzed.
Measured: Baseline, within 3 to 12 months
Histopathological analysis of duodenal biopsies
Intestinal biopsies, which are routinely taken during esophagogastroduodenoscopy, are processed for histopathological analysis of the mucosal and epithelial structure as well as of the immune cell compartment and to rule out inflammatory processes or intestinal infections.
Measured: Baseline, within 3 to 12 months
Immunohistochemical analysis of duodenal biopsies
Intestinal biopsies, which are routinely taken during esophagogastroduodenoscopy, are stained using immunohistochemistry and examined for the expression of specific marker proteins (e.g. CD3, eosinophils, Occludin, Claudins).
Measured: Baseline, within 3 to 12 months
IgE antibody titers
IgE screening of antibodies against typical food allergens (egg white, soy, milk, yeast, wheat) in the serum
Measured: Baseline, within 3 to 12 months
Analysis of fecal biomarkers, digestive parameters, intestinal flora
The concentrations of different fecal biomarkers are analyzed in stool samples:
Calprotectin, Lactoferrin, PMN-Elastase, EDN, Zonulin, Alpha-1-Antitrypsin, Beta-Defensin.
Furthermore, digestive parameters such as digestion residues and the intestinal flora are determined.
Measured: Baseline, within 3 to 12 months
Result of hydrogen breath tests
Lactose, fructose, and sorbitol intolerance is tested via hydrogen breath test
Measured: Baseline, within 3 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen, Universität Duisburg-Essen, Sozialstiftung Bamberg
- Responsible party
- Principal investigator, Michael Jeitler, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040475
- Sponsor's protocol ID
- Minerva
- Acronym
- Minerva
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Clinical Application of TCIM Procedures During Inpatient Stays in Germany - a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07040475
- Acronym / sponsor ID
- Minerva / Minerva
- Conditions
- Chronic Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Universität Tübingen, Universität Duisburg-Essen, Sozialstiftung Bamberg
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jun 2025 (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.
The aim of this healthcare research project is to evaluate the effects of routine inpatient TCIM (Traditional, Complementary and Integrative Medicine) care in Germany. The focus is on the TCIM centers at Immanuel Krankenhaus Berlin, Klinikum Bamberg und Evang. Kliniken Essen-Mitte, where inpatient TCIM therapies are to be systematically evaluated. This form of therapy, which is reimbursed by statutory health insurance providers (under certain conditions), is based on a combination of various evidence-based TCIM approaches. These include hyperthermia, exercise therapy, Mind-Body Medicine, phytotherapy, nutritional therapy, fasting therapy inter alia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCIM | – | Other: Inpatient TCIM therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in TCIM wards are offered the opportunity to participate in this study.
Key inclusion criteria (2 listed)
- Beginning (first 24 hours) inpatient TCIM treatment at Immanuel Hospital Berlin, Bamberg Hospital, or Evangelische Kliniken Essen-Mitte
- Written consent form
Key exclusion criteria (4 listed)
- Insufficient language skills
- Dementia or other severely impairing cognitive disorders
- Pregnancy or breastfeeding
- Participation in a clinical study
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 |
|---|---|---|
| Inpatient TCIM therapyThis multicenter, prospective, uncontrolled observational study is evaluating the effects and safety of inpatient TCIM therapy (German: naturheilkundliche Komplextherapie) at three German clinics: Immanuel Hospital Berlin, Klinikum Bamberg, and Evangelical Clinics Essen-Mitte. This therapy, reimbursed by statutory health insurance under certain conditions, combines evidence-informed TCIM approaches such as hyperthermia, exercise therapy, phytotherapy, and dietary interventions including fasting i.a. | Other | TCIM |
Primary outcome
Short Form Health Survey - 12 Items (SF-12)
Time frame: Baseline, 3 months
0-100, higher scores indicate better health status.
50 secondary outcomes
Short Form Health Survey - 12 Items (SF-12)
Time frame: Baseline, up to 14 days, 6 months, 12 months
EuroQol 5-Dimension 5-Level
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Food Frequency List
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
International Physical Activity Questionnaire - Short Form
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Hospital Anxiety and Depression Scale
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Work Productivity and Activity Impairment Questionnaire
Time frame: Baseline, 3 months, 6 months, 12 months
Perceived Stress Scale - 4
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Main complaint
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Fibromyalgia Impact Questionnaire
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Rheumatoid Arthritis Disease Activity Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Bath Ankylosing Spondylitis Disease Activity Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Bath Ankylosing Spondylitis Functional Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Irritable Bowel Syndrome Symptom Severity Score
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Short Inflammatory Bowel Disease Questionnaire
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Pain Disability Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Roland Morris Disability Questionnaire
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Maslach Burnout Inventory
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Beck Depression Inventory-II
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Diabetes Distress Scale - 2
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Dermatology Life Quality Index
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Functional Assessment of Cancer Therapy - General
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Use of the healthcare system
Time frame: Baseline,12 months
Expectations regarding inpatient TCIM treatment
Time frame: Baseline
Chalder Fatigue Scale
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Somatic Symptom Scale
Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months
Body weight [kg]
Time frame: Baseline, up to 14 days
Height [in cm]
Time frame: Baseline
BMI [kg/m2]
Time frame: Baseline, up to 14 days
Systolic blood pressure [mmHg], diastolic blood pressure [mmHg]
Time frame: Baseline, up to 14 days
Waist circumference [in cm]
Time frame: Baseline, up to 14 days
Triglycerides [mg/dl]
Time frame: Baseline, up to 14 days
Total cholesterol [mg/dl]
Time frame: Baseline, up to 14 days
HDL [mg/dl]
Time frame: Baseline, up to 14 days
LDL [mg/dl]
Time frame: Baseline, up to 14 days
Glucose [mg/dl]
Time frame: Baseline, up to 14 days
Uric acid [μmol/L]
Time frame: Baseline, up to 14 days
Creatinine [mg/dl]
Time frame: Baseline, up to 14 days
CRP [mg/l]
Time frame: Baseline, up to 14 days
GPT [U/l]
Time frame: Baseline, up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
Holger Cramer, Prof. Dr. contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Charite University, Berlin, Germany at 3 sites in Germany.
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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Jeitler, PD Dr. (03080505682, naturheilkunde@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form Health Survey - 12 Items (SF-12) (time frame: Baseline, 3 months). 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 26 Dec 2025.