Condition category
Musculoskeletal Diseases
Date applied
05/01/2007
Date assigned
09/02/2007
Last edited
12/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ccmp.gov.tw/en/index.asp

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

Publication citations

Additional files

Editorial Notes