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
Secondary identifying numbers 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

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

Email chungjen@adm.cgmh.org.tw

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific titleApplication of Dan-Chi-Liu-Wei combination in systemic lupus erythematosus patients to taper steroid use and to prevent disease flare
Study objectivesWe 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) studiedSystemic Lupus Erythematosus
InterventionUse of Dan-Chi-Liu-Wei (DCLW) Chinese herbal combination (full strength) versus control (receive a 10% placebo).
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dan-Chi-Liu-Wei Chinese herbal combination
Primary outcome measureDosage of steriods after six months of combined therapy (DCLW and regular drugs)
Secondary outcome measures1. Frequency of disease flares after six months of combined therapy (DCLW and regular drugs)
2. Immunologic index (C3, C4, anti-ds-DeoxyriboNucleic Acid [DNA]) after six months of combined therapy (DCLW and regular drugs)
Overall study start date01/02/2007
Completion date31/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants160
Total final enrolment53
Key inclusion criteria1. 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 criteria1. 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 enrolment01/02/2007
Date of final enrolment31/12/2007

Locations

Countries of recruitment

  • Taiwan

Study participating centre

Chang Gung Memorial Hospital
Kaohsiung Hsien
833
Taiwan

Sponsor information

Department of Health (Taiwan)
Government

The Committee on Chinese Medicine and Pharmacy
Executive Yuan
-
-
Taiwan

Email webmaster@ccmp.gov.tw
Website http://www.ccmp.gov.tw/en/index.asp
ROR logo "ROR" https://ror.org/0225asj53

Funders

Funder type

Government

Department of Health (Taiwan) (ref:CCMP95-TP-025)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.