Randomised, controlled, double-blind trial of Chinese Herbal Medicine as adjuvant treatment in patients with Crohn's disease
| ISRCTN | ISRCTN69696725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69696725 |
| Secondary identifying numbers | CHM-Crohn |
- Submission date
- 29/05/2002
- Registration date
- 29/05/2002
- Last edited
- 16/04/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Detlef Schuppan
Scientific
Scientific
Krankenhausstrasse 12
Erlangen
91054
Germany
| Phone | +49 (0)9131 853 33 98 |
|---|---|
| detlef.schuppan@med1.imed.uni-erlangen.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study acronym | CHM-Crohn |
| Study objectives | Not provided at time of registration. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration. |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/04/2000 |
| Completion date | 30/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/04/2000 |
| Date of final enrolment | 30/04/2002 |
Locations
Countries of recruitment
- Germany
Study participating centre
Krankenhausstrasse 12
Erlangen
91054
Germany
91054
Germany
Sponsor information
Friedrich-Alexander-University of Erlangen-Nuremberg (Germany)
University/education
University/education
Postfach 3520
Erlangen
D-91023
Germany
| Phone | +49 (0)9131 85 0 |
|---|---|
| Website | http://www.uni-erlangen.org/ |
"ROR" |
https://ror.org/00f7hpc57 |
Funders
Funder type
Research organisation
Rut- and Klaus-Bahlsen-Foundation (Germany)
No information available
University Hospital of Erlangen (Germany) - Erlanger Leistungsbezogene Anschubfinanzierung und Nachwuchsforderung (ELAN) fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
