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 |
| Protocol serial number | CHM-Crohn |
| Sponsor | Friedrich-Alexander-University of Erlangen-Nuremberg (Germany) |
| Funders | Rut- and Klaus-Bahlsen-Foundation (Germany), University Hospital of Erlangen (Germany) - Erlanger Leistungsbezogene Anschubfinanzierung und Nachwuchsforderung (ELAN) fund |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Not provided at time of registration. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 30/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
