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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCharite University, Berlin, Germany

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Written consent form

Disqualifiers

Insufficient language skills

Dementia or other severely impairing cognitive disorders

Pregnancy or breastfeeding

Participation in a clinical study

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Inpatient TCIM therapy

    Other intervention

    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.

Treatment groups

2,500 Participants
are divided into 1 treatment group
Group A: TCIM1 intervention

Trial outcomes

Primary outcomes

1

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

0-100, higher scores indicate better health status.

Time frame
Baseline, 3 months

Secondary outcomes

1

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

0-100, higher scores indicate better health status.

Time frame
Baseline, up to 14 days, 6 months, 12 months
2

EuroQol 5-Dimension 5-Level

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

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

Food Frequency List

Descriptive measure; not scored on a numeric scale.

Time frame
Baseline, up to 14 days, 3 months, 6 months, 12 months
4

International Physical Activity Questionnaire - Short Form

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

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Universität Tübingen

Collaborator

Universität Duisburg-Essen

Collaborator

Sozialstiftung Bamberg

Collaborator