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

NCT07040475 | Recruiting

• 1 other identifier: Minerva
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survey - 12 Items (SF-12)

  0-100, higher scores indicate better health status.

  Baseline, 3 months

Secondary Outcomes (50)

• Short Form Health Survey - 12 Items (SF-12)

  Baseline, up to 14 days, 6 months, 12 months

• EuroQol 5-Dimension 5-Level

  Baseline, up to 14 days, 3 months, 6 months, 12 months

• Food Frequency List

  Baseline, up to 14 days, 3 months, 6 months, 12 months

• International Physical Activity Questionnaire - Short Form

  Baseline, up to 14 days, 3 months, 6 months, 12 months

• Hospital Anxiety and Depression Scale

  Baseline, up to 14 days, 3 months, 6 months, 12 months

Other Outcomes (12)

• Number of participants with diagnoses

  Baseline, up to 14 days, 3 months, 6 months, 12 months

• Number of participants taking pain medication

  Baseline, up to 14 days, 3 months, 6 months, 12 months

• Number of participants taking antidepressive medication

  Baseline, up to 14 days, 3 months, 6 months, 12 months

Study Arms (1)

TCIM

Other: Inpatient TCIM therapy

Interventions

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.

TCIM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in TCIM wards are offered the opportunity to participate in this study.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Universität Tübingen: collaborator
• Universität Duisburg-Essen: collaborator
• Sozialstiftung Bamberg: collaborator

Study Sites (3)

Sozialstiftung Bamberg, Klinikum Bamberg

Bamberg, 96049, Germany

RECRUITING

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus, Institut für Sozialmedizin, Epidemiologie und Gesundheitsökonomie, Charité - Universitätsmedizin Berlin

Berlin, 14109, Germany

RECRUITING

Klinik für Naturheilkunde und Integrative Medizin, KEM

Essen, 45276, Germany

RECRUITING

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michael Jeitler, PD Dr.

CONTACT

03080505682; naturheilkunde@charite.de

Holger Cramer, Prof. Dr.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

DE (3)