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NCT Number: NCT07040475

Effects of the Clinical Application of Traditional, Complementary and Integrative Medicine (TCIM) Procedures During Inpatient Stays in Germany

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sozialstiftung Bamberg, Klinikum Bamberg, Bamberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Beginning (first 24 hours) inpatient TCIM treatment at Immanuel Hospital Berlin, Bamberg Hospital, or Evangelische Kliniken Essen-Mitte
  • Written consent form

Exclusion criteria

  • Insufficient language skills
  • Dementia or other severely impairing cognitive disorders
  • Pregnancy or breastfeeding
  • Participation in a clinical study

Treatment and study plan

Inpatient TCIM therapy

Other

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.

Primary outcomes

  1. Short Form Health Survey - 12 Items (SF-12)

    Time frame: Baseline, 3 months

    0-100, higher scores indicate better health status.

Secondary outcomes

  1. Short Form Health Survey - 12 Items (SF-12)

    Time frame: Baseline, up to 14 days, 6 months, 12 months

    0-100, higher scores indicate better health status.

  2. EuroQol 5-Dimension 5-Level

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0 (worst) to 1 (best), higher scores indicate better health-related quality of life.

  3. Food Frequency List

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    Descriptive measure; not scored on a numeric scale.

  4. International Physical Activity Questionnaire - Short Form

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    MET-min/week (variable), higher scores indicate higher physical activity levels.

  5. Hospital Anxiety and Depression Scale

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-21 per subscale (Anxiety and Depression), higher scores indicate more severe symptoms.

  6. Work Productivity and Activity Impairment Questionnaire

    Time frame: Baseline, 3 months, 6 months, 12 months

    0%-100%, higher scores indicate greater impairment (i.e., worse outcome).

  7. Perceived Stress Scale - 4

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-16, higher scores indicate higher perceived stress.

  8. Main complaint

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    Visual Analog Scale (0-100, higher scores mean a worse outcome)

  9. Fibromyalgia Impact Questionnaire

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-100, higher scores indicate greater impact of fibromyalgia (worse outcome).

  10. Rheumatoid Arthritis Disease Activity Index

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-10, higher scores indicate greater disease activity (worse outcome).

  11. Bath Ankylosing Spondylitis Disease Activity Index

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-10, higher scores indicate more active disease (worse outcome).

  12. Bath Ankylosing Spondylitis Functional Index

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-10, higher scores indicate more functional limitation (worse outcome).

  13. Western Ontario and McMaster Universities Osteoarthritis Index

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-100, higher scores indicate greater pain/stiffness/disability (worse outcome).

  14. Irritable Bowel Syndrome Symptom Severity Score

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-500, higher scores indicate more severe IBS symptoms (worse outcome).

  15. Short Inflammatory Bowel Disease Questionnaire

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    10-70, higher scores indicate better quality of life.

  16. Pain Disability Index

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-70, higher scores indicate greater disability (worse outcome).

  17. Roland Morris Disability Questionnaire

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-24, higher scores indicate more severe disability (worse outcome).

  18. Maslach Burnout Inventory

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    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.

  19. Beck Depression Inventory-II

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-63, higher scores indicate more severe depressive symptoms (worse outcome).

  20. Diabetes Distress Scale - 2

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    1-6, higher scores indicate greater emotional distress related to diabetes (worse outcome).

  21. Dermatology Life Quality Index

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-30, higher scores indicate greater impact on quality of life (worse outcome).

  22. Functional Assessment of Cancer Therapy - General

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-108, higher scores indicate better quality of life.

  23. Use of the healthcare system

    Time frame: Baseline,12 months

    Descriptive data (e.g., number of visits); not a scored scale.

  24. Expectations regarding inpatient TCIM treatment

    Time frame: Baseline

    5-point Likert scale, 1-5. Higher scores indicate stronger or more positive expectations.

  25. Chalder Fatigue Scale

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-33, higher scores mean a worse outcome

  26. Somatic Symptom Scale

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    0-32, higher scores mean a worse outcome

  27. Body weight [kg]

    Time frame: Baseline, up to 14 days

  28. Height [in cm]

    Time frame: Baseline

  29. BMI [kg/m2]

    Time frame: Baseline, up to 14 days

  30. Systolic blood pressure [mmHg], diastolic blood pressure [mmHg]

    Time frame: Baseline, up to 14 days

  31. Waist circumference [in cm]

    Time frame: Baseline, up to 14 days

  32. Triglycerides [mg/dl]

    Time frame: Baseline, up to 14 days

  33. Total cholesterol [mg/dl]

    Time frame: Baseline, up to 14 days

  34. HDL [mg/dl]

    Time frame: Baseline, up to 14 days

  35. LDL [mg/dl]

    Time frame: Baseline, up to 14 days

  36. Glucose [mg/dl]

    Time frame: Baseline, up to 14 days

  37. Uric acid [μmol/L]

    Time frame: Baseline, up to 14 days

  38. Creatinine [mg/dl]

    Time frame: Baseline, up to 14 days

  39. CRP [mg/l]

    Time frame: Baseline, up to 14 days

  40. GPT [U/l]

    Time frame: Baseline, up to 14 days

  41. HbA1c [mmol/mol]

    Time frame: Baseline, up to 14 days

  42. HbA1c [%]

    Time frame: Baseline, up to 14 days

  43. Headache Impact Test (HIT-6)

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

    36-78. A higher value indicates a greater impairment due to headaches.

  44. Integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)

    Time frame: Baseline, within 3 to 12 months

    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.

  45. Result of the esophagogastro-duodenoscopy

    Time frame: Baseline, within 3 to 12 months

    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.

  46. Histopathological analysis of duodenal biopsies

    Time frame: Baseline, within 3 to 12 months

    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.

  47. Immunohistochemical analysis of duodenal biopsies

    Time frame: Baseline, within 3 to 12 months

    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).

  48. IgE antibody titers

    Time frame: Baseline, within 3 to 12 months

    IgE screening of antibodies against typical food allergens (egg white, soy, milk, yeast, wheat) in the serum

  49. Analysis of fecal biomarkers, digestive parameters, intestinal flora

    Time frame: Baseline, within 3 to 12 months

    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.

  50. Result of hydrogen breath tests

    Time frame: Baseline, within 3 to 12 months

    Lactose, fructose, and sorbitol intolerance is tested via hydrogen breath test

Other outcomes

  1. Number of participants with diagnoses

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  2. Number of participants taking pain medication

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  3. Number of participants taking antidepressive medication

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  4. Number of participants taking anxiolytics

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  5. Number of participants taking migraine medication

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  6. Number of participants taking antihypertensive medication

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  7. Number of participants taking lipid-lowering medication

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  8. Number of participants taking corticosteroids

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  9. Number of participants taking antidiabetic medication

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  10. Number of participants taking biologics

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  11. Number of participants taking immunosuppressants

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

  12. Adverse events

    Time frame: Baseline, up to 14 days, 3 months, 6 months, 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Holger Cramer, Prof. Dr.

CONTACT

Michael Jeitler, PD Dr.

CONTACT

[email protected]

03080505682

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Sozialstiftung Bamberg
  • Universität Duisburg-Essen
  • Universität Tübingen

Registry information

Official study title

Effects of the Clinical Application of TCIM Procedures During Inpatient Stays in Germany - a Multicenter Observational Study

Acronym: Minerva

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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