Application of Dan-Chi-Liu-Wei combination in systemic lupus erythematosus patients to taper steroid use and to prevent disease flare
| ISRCTN | ISRCTN73842582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73842582 |
| Protocol serial number | CCMP95-TP-025 |
| Sponsor | Department of Health (Taiwan) |
| Funder | Department of Health (Taiwan) (ref:CCMP95-TP-025) |
- Submission date
- 05/01/2007
- Registration date
- 09/02/2007
- Last edited
- 09/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Chung-Jen Chen
Scientific
Scientific
Chang Gung Memorial Hospital
Kaohsiung Medical Center
Chang Gung University College of Medicine
No. 123, Ta-Pei Road
Niao-Sung Hsiang
Kaohsiung Hsien
833
Taiwan
| chungjen@adm.cgmh.org.tw |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Application of Dan-Chi-Liu-Wei combination in systemic lupus erythematosus patients to taper steroid use and to prevent disease flare |
| Study objectives | We hypothesise that Dan-Chi-Liu-Wei (DCLW) Chinese herbal combination would provide a novel complimentary therapy in assisting the tapering of steroid (by approximately 10 mg/day) and decreasing the frequency of disease flare in Systemic Lupus Erythematosus (SLE) patients (by more than 50%) after six months of therapy. |
| Ethics approval(s) | Approval received from the Chang Gung Memorial Hospital: CGMH 95-0951B (9 Nov 2006) and Kaohsiung Medical University Hospital: KMUHCTC-950003 (17 Oct 2006). |
| Health condition(s) or problem(s) studied | Systemic Lupus Erythematosus |
| Intervention | Use of Dan-Chi-Liu-Wei (DCLW) Chinese herbal combination (full strength) versus control (receive a 10% placebo). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dan-Chi-Liu-Wei Chinese herbal combination |
| Primary outcome measure(s) |
Dosage of steriods after six months of combined therapy (DCLW and regular drugs) |
| Key secondary outcome measure(s) |
1. Frequency of disease flares after six months of combined therapy (DCLW and regular drugs) |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 160 |
| Total final enrolment | 53 |
| Key inclusion criteria | 1. Using the 1997 revised criteria for the classification of SLE over four categories: patients with mild to moderate activity (Systemic Lupus Erythematosus Disease Activity Index [SLEDAI] grade two to 12) will be recruited 2. Prednisolone use below 20 mg/day |
| Key exclusion criteria | 1. Currently pregnant, or plan to be pregnant (subjects who become pregnant during study at any time will be excluded) 2. Less than or equal to 18 years of age 3. More than or equal to 60 years of age 4. Serum creatinine more than or equal to 1.4 mg/dl |
| Date of first enrolment | 01/02/2007 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Chang Gung Memorial Hospital
Kaohsiung Hsien
833
Taiwan
833
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2011 | 09/05/2019 | Yes | No |
Editorial Notes
09/05/2019: Publication reference and total final enrolment added.
