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Recruiting NCT07040475

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

— Observational Chronic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inpatient TCIM therapy.
Who it may be relevant to
Registry conditions: Chronic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Inpatient TCIM therapy
    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

Primary outcome measures

  • Short Form Health Survey - 12 Items (SF-12) [Time frame: Baseline, 3 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 3 centers
  • Sozialstiftung Bamberg, Klinikum Bamberg — Bamberg
  • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus, Institut für Sozialm — Berlin
  • Klinik für Naturheilkunde und Integrative Medizin, KEM — Essen

Identifiers

NCT: NCT07040475 · Minerva

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗