Condition category
Digestive System
Date applied
29/05/2002
Date assigned
29/05/2002
Last edited
16/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Detlef Schuppan

ORCID ID

Contact details

Krankenhausstrasse 12
Erlangen
91054
Germany
+49 (0)9131 853 33 98
detlef.schuppan@med1.imed.uni-erlangen.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CHM-Crohn

Study information

Scientific title

Acronym

CHM-Crohn

Study hypothesis

Not provided at time of registration.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Crohn's disease

Intervention

1. Chinese Herbal Medicine Preparation (capsuled pulverised Chinese Medicinal Recipe; 11 drugs) to be taken for 12 weeks; 9 g daily
2. Placebo (identical in taste and flavour); 12 weeks, 9 g daily

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/04/2000

Overall trial end date

30/04/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. 60 participants
2. Disease duration greater than 1 year
3. Crohn's Disease Activity Index (CDAI) 150 - 450
4. Aged 18 - 60 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/04/2000

Recruitment end date

30/04/2002

Locations

Countries of recruitment

Germany

Trial participating centre

Krankenhausstrasse 12
Erlangen
91054
Germany

Sponsor information

Organisation

Friedrich-Alexander-University of Erlangen-Nuremberg (Germany)

Sponsor details

Postfach 3520
Erlangen
D-91023
Germany
+49 (0)9131 85 0

Sponsor type

University/education

Website

http://www.uni-erlangen.org/

Funders

Funder type

Research organisation

Funder name

Rut- and Klaus-Bahlsen-Foundation (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Hospital of Erlangen (Germany) - Erlanger Leistungsbezogene Anschubfinanzierung und Nachwuchsforderung (ELAN) fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes