Contact information
Type
Scientific
Primary contact
Prof Chung-Jen Chen
ORCID ID
Contact details
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
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CCMP95-TP-025
Study information
Scientific title
Acronym
Study hypothesis
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
Approval received from the Chang Gung Memorial Hospital: CGMH 95-0951B (9 Nov 2006) and Kaohsiung Medical University Hospital: KMUHCTC-950003 (17 Oct 2006).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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 names
Dan-Chi-Liu-Wei Chinese herbal combination
Primary outcome measures
Dosage of steriods after six months of combined therapy (DCLW and regular drugs)
Secondary outcome measures
1. 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 trial start date
01/02/2007
Overall trial end date
31/12/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant 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
Recruitment start date
01/02/2007
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Taiwan
Trial participating centre
Chang Gung Memorial Hospital
Kaohsiung Hsien
833
Taiwan
Sponsor information
Organisation
Department of Health (Taiwan)
Sponsor details
The Committee on Chinese Medicine and Pharmacy
Executive Yuan
-
-
Taiwan
webmaster@ccmp.gov.tw
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (Taiwan) (ref:CCMP95-TP-025)
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