Brief Summary

The observational study aims to investigate the extent to which a two-week stay in an internal medicine clinic for integrative medicine and naturopathy results in an improvement of complaints, impairments, quality of life, anxiety/depressiveness, stress perception and well-being in chronic gastroenterological patients and chronic rheumatological/pain patients. In addition, previous experiences with complementary naturopathic procedures, expectations of treatment, perceived benefits and implementation of instructed techniques and procedures in everyday life will be investigated. Since May 2021, patients with Post Covid-19 Syndrome have been treated as inpatients during a stay that usually lasts 14 days. Since January 2022 these patients are evaluated in the substudy "StaPoCo". Since 2022 Post Covid-19 Syndrome day clinic patients were also evaluated. Sub-Study "Intestinal barrier dysfunction" - Gastroenterological patients who undergo routine gastroscopy and/or colonoscopy with confocal laser endomicroscopy (cLE) and tissue biopsies at the beginning of their inpatient stay are explicitly examined for the presence of a barrier disorder. Since May 2021 patients can take part in the day clinic programme one day weekly for ten or eleven weeks. In this programme also patients with oncological disorders take part. Starting in the fall of 2022, the integrative medicine/naturopathic day clinics at the Immanuel Hospital in Berlin and the Ev. Kliniken Essen-Mitte will be included in the evaluation.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach

1 country

3 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 years study duration

Study Start

First participant enrolled

January 4, 2021

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed

2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed

Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

April 13, 2021

Last Update Submit

January 30, 2023

Conditions

Chronic Disease

Keywords

irritable bowel syndromeulcerative colitisCrohn's diseasepain patientsrheumatismfibromyalgia syndromeintegrative medicinenaturopathyirritable bowel diseasechronic pain syndromecomplementary medicinepost Covid syndromeoncological diseasesday clinic

Outcome Measures

Primary Outcomes (3)

Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
week 0
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
week 2 (inpatient), week 10/11 (day clinic)
Generic quality of life
SF-12, Short Form 36 Health Survey Questionnaire
week 24 (inpatient), week 34/35 (day clinic)

Secondary Outcomes (120)

anxiety and depression
week 0
anxiety and depression
week 2 (inpatient), week 10/11 (day clinic)
anxiety and depression
week 24 (inpatient), week 34/35 (day clinic)
sex
week 0
age
week 0
+115 more secondary outcomes